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Manager, Quality Systems & Operations
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eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
OVERVIEW
The Manager, Quality Systems & Operations (QSO) is responsible for leading the day-to-day operation, governance, and continuous improvement of the organization’s Quality Management System (QMS) within a regulated clinical technology environment. This role serves as the operational backbone (“engine room”) of the Quality & Compliance function and ensures quality processes are efficient, inspection-ready, risk-based, and aligned with the needs of a clinical trial software / technology-enabled services organization.
The Manager, QSO will oversee core quality system processes including document control, SOP lifecycle management, training administration and effectiveness support, quality events and CAPA management, quality metrics and management reporting, and cross-functional process improvement initiatives. This role partners closely with Product, Engineering, Information Security, Operations, Client Services, Audits & Assurance (AA), and Systems & Regulatory Compliance (SRC) to support GxP expectations, customer requirements, and operational excellence.
KEY TASKS & RESPONSIBILITIES
➢ Quality Management System (QMS) Ownership
- Own the administration, maintenance, and continuous improvement of the enterprise QMS supporting a clinical trial software / vendor services environment.
- Manage controlled documentation processes including SOPs, policies, work instructions, templates, validation documentation, and periodic reviews.
- Ensure document control practices meet internal governance, client expectations, and applicable GxP / computerized systems requirements.
- Maintain version control, approvals, archival, training linkage, and retention controls for quality records.
➢ Quality Operations / Day-to-Day Oversight
- Serve as operational lead for daily quality system workflows, requests, escalations, and prioritization.
- Ensure timely execution of quality deliverables including document approvals, event reviews, CAPA follow-up, training assignments, and management reporting.
- Coordinate core quality activities across business and technical functions in a fast-paced SaaS / vendor setting.
➢ Quality Events, Investigations & CAPA
- Oversee quality events including deviations, incidents, customer quality issues, audit observations, system/process nonconformances, and supplier quality concerns as applicable.
- Manage CAPA lifecycle from initiation through closure, including root cause analysis, action tracking, due dates, evidence review, and effectiveness verification.
- Facilitate governance reviews for aging items, repeat issues, overdue actions, and systemic trends.
- Support quality investigations involving validated systems, software releases, data integrity concerns, or service delivery issues.
➢ Training Program Support & Effectiveness
- Support administration of the quality training program and learning compliance processes.
- Ensure role-based training matrices align with regulated responsibilities and controlled procedures.
- Provide guidance on training effectiveness assessments, retraining triggers, and onboarding quality training.
- Monitor completion rates, overdue training, and training-related KPIs.
➢ Metrics, KPIs & Management Reporting
- Develop and maintain enterprise quality dashboards, KPIs, and trend reports.
- Report on QMS health including document control cycle times, CAPA status, training compliance, audit observations, quality events, and recurring risks.
- Use data to identify improvement opportunities and inform management review activities.
➢ Continuous Improvement / Operational Excellence
- Identify opportunities to streamline, automate, and mature quality processes while maintaining compliance.
- Lead initiatives to improve user experience and adoption of quality systems/tools.
- Support implementation, configuration, or enhancement of electronic QMS (eQMS), LMS, issue management, and workflow tools.
➢ Cross-Functional Partnership
- Partner with Product, Engineering, DevOps, Security, and Operations teams to embed practical quality controls into business processes.
- Collaborate with Audits & Assurance (AA) on internal/external audit readiness, observations, and remediation.
- Collaborate with Systems & Regulatory Compliance (SRC) on GxP requirements, supplier/customer obligations, validation governance, and regulatory commitments.
- Support client due diligence requests, quality questionnaires, and customer audits as needed.
➢ Other duties as assigned
Education & Experience
➢ Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, Business, or related discipline preferred
➢ 12+ years of experience in Quality Systems, Quality Operations, Compliance, or related roles within a regulated environment preferred
➢ Experience in a clinical trial software vendor, SaaS healthcare technology, CRO, life sciences technology, eClinical, or related GxP-supporting organization
➢ ASQ, Six Sigma, ISO, GxP, or related certifications preferred
Professional Skills
➢ Working knowledge of GxP principles, computerized systems controls, data integrity expectations, and risk-based quality management
➢ Experience supporting customer audits, supplier audits, or regulatory inspections preferred
➢ Experience managing CAPA, investigations, document control, training systems, and quality metrics
➢ Strong communication, organization, and stakeholder management skills
➢ Familiarity with CSV / CSA concepts and validation documentation for regulated systems preferred
Technical Skills
➢ Experience using electronic QMS platforms and workflow systems
➢ Experience with tools such as Qualio, Veeva, MasterControl, TrackWise, Jira, or similar platforms preferred
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
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Consultant - Insights COE
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ClearView Healthcare Partners is a premier life sciences strategy consulting firm headquartered in Boston, with offices in San Francisco, New York City, London and Gurgaon. Serving clients in the biopharmaceutical, medical device, and diagnostic spaces, we provide world-class strategic decision-making support across a diverse range of business issues. Our goal is to inform actionable recommendations that allow companies to achieve their business objectives.
Role Overview:
As an Insights/Secondary research - CoE team member, you will partner closely with global consulting teams to deliver high quality secondary research, market insights, and targeted analyses that inform strategic recommendations for our life sciences clients. You will develop a strong foundation in the life sciences industry and exposure to a diverse set of strategic questions across the product lifecycle. The work will span questions related to clinical development, commercialization, pricing and market access, launch planning, corporate and investor strategy, diagnostics, and new product planning.
Key Responsibilities:
- Conduct targeted secondary research on diseases, therapies, competitors, clinical pipelines, and market dynamics using public and proprietary data sources (e.g., EvaluatePharma, GlobalData, Navlin, MMIT, AnswerSuite, company filings, HTA portals).
- Synthesize research findings into clear, structured, and slide‑ready deliverables, including market landscapes, analytical frameworks, and concise written insights.
- Develop disease, assets, and company overviews; treatment algorithms; guideline and standard of care maps; and epidemiology driven market context summaries to support a broad range of strategic work.
- Perform analog research and benchmarking across launch, uptake, access, pricing, evidence generation, and go‑to‑market strategies to inform strategic decision‑making
- Summarize HTA, payer, and reimbursement decisions, identifying key value messages, evidence expectations, pricing and access outcomes, and drivers of payer decisions across markets.
- Prepare structured competitor and payer relevant profiles, including strategy, evidence, positioning, and deal or funding activity, to support both project and internal business development needs.
- Build and maintain reusable research assets, including competitive landscapes, analog libraries, launch timelines, and technology and policy trend trackers.
- Support qualitative research efforts by helping prepare discussion guides, synthesizing interview notes, and organizing insights for hypothesis testing.
- Work with global consulting colleagues to clarify problem statements, refine research questions, and iteratively improve output based on feedback.
- Contribute to the creation of templated outputs that integrate research insights into overall project deliverables (e.g., storyline aligned slides, appendices, and supporting materials).
- Ensure quality and consistency of research outputs by adhering to internal standards, referencing guidelines, and formatting best practices.
- Participate in internal knowledge building initiatives, including upkeep of internal knowledge repositories, templates, and best practice examples.
Qualifications & Requirements:
- 4-6 years of experience in life sciences consulting, market research, competitive intelligence, HTA / HEOR support, or similar insights focused roles.
- Undergraduate or master’s degree in a life science discipline (e.g., biology, biochemistry, pharmacology, biotechnology, pharmacy) or related field.
- Demonstrated interest in the global biopharmaceutical industry and strategic questions related to R&D, commercialization, pricing & access, launch and lifecycle management, diagnostics, and corporate / investor strategy.
- Ability to independently execute well-scoped research workstreams (e.g., literature scans, competitive profiles, basic epidemiology/market sizing desk research) with moderate oversight.
- High attention to detail in referencing, data checking, and ensuring consistency of narratives and exhibits across multiple sources.
- Strong written and verbal communication skills in English, with the ability to translate complex scientific and commercial concepts into accessible, actionable insights.
- Highly analytical and structured approach to organizing information and building logical narratives from evidence.
- Enthusiasm for collaborating with distributed global teams and comfort working across time zones.
- Strong proficiency in Microsoft PowerPoint and Excel; familiarity with common life science data and literature sources (e.g., clinical trial registries, scientific literature, company reports, analyst reports) is a plus.
- Ability to work in a hybrid setup, with 3 days per week from the Gurgaon office.
What We Value
We recognize that not every candidate will meet every qualification listed. If you’re excited about this role and believe you have relevant experience or transferable skills, we encourage you to apply. We value curiosity, a growth mindset, and a commitment to collaboration.
Equal Opportunity Employer
ClearView Healthcare Partners ("CV") is an Equal Opportunity employer. All qualified applicants will be considered for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law.
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ABOUT OLIPOP
At OLIPOP, we’re on a mission to positively impact consumer health at scale. And we’re doing it through something simple: soda. But not just any soda, a new kind of soda: one that’s delicious, refreshing, and actually good for you.
This mission is deeply personal for our CEO, Co-Founder, and Formulator, Ben Goodwin. Like many of us, Ben grew up consuming the Standard American Diet: lots of soda and processed foods that prioritized convenience over nutrition. But at 14, he took his health into his own hands. After making significant changes to his nutrition and exercise, he lost 50 pounds and saw a transformation in his energy, mood, and emotional clarity.
Those changes sparked a deep curiosity about the connection between nutrition and health. Ben became a relentless student of the gut microbiome and the ways it supports overall wellness. The more he discovered, the more passionate he became about finding credible, science-backed ways to make consumer health accessible to everyone.
The mission was clear. The vehicle? Less so. After exploring the possibilities, Ben landed on an unexpected yet familiar choice: soda. It was something he loved as a kid, and he knew millions shared that same nostalgia. But this wouldn’t be just any soda. With most Americans falling short on daily fiber, Ben set out to create a version with more fiber and less sugar, one that was perfectly balanced. The result? A deliciously refreshing soda with 6 to 9 grams of fiber and 2 to 5 grams of sugar, delivering science-backed benefits without sacrificing the classic taste people crave.
In 2018, the first OLIPOP cans hit the shelves, bringing Ben’s vision to life with a functional soda that anyone could enjoy. And by reimagining soda, we’re also reshaping culture. That means creating products that support health for all and building a business grounded in humanistic values: empathy, integrity, and a belief in better for everyone. From the ingredients we source to the culture we foster, we’re committed to proving that business (and beverage!) can be a force for good, and that soda has the power to bring people together.
So join us, and let’s write a new American soda story together. One we can all feel good about. One OLIPOP at a time.
ABOUT THE ROLE
As a Field Marketing Manager, you will be the face of OLIPOP in your region, driving grassroots awareness and trial through local guerrilla marketing efforts, event activations, and in-store sampling programs. This role requires a dynamic, entrepreneurial mindset and strong leadership skills to supervise a team of Brand Ambassadors and execute high-impact marketing initiatives that connect national strategy with local execution.
Location: Dallas–Fort Worth Metroplex (Dallas preferred). Ideal candidates will be based on the Dallas side of the metro, including areas such as Plano or Frisco. Ability to travel within the DFW area as needed (up to 1–2 hours). Approximately 45 minutes from Dallas–Fort Worth International Airport.
This role requires a strong local presence, with an average of 4 days per week committed to in-market activities in these regions.
RESPONSIBILITIES
Local Marketing & Sampling
- Plan and execute guerrilla sampling programs to drive brand awareness and trial.
- Build relationships with local businesses, influencers, and event organizers to maximize impact.
- Adapt national marketing campaigns for local audiences.
Event Activation & Sponsorships
- Coordinate OLIPOP presence at major events (e.g., festivals, marathons, trade shows).
- Negotiate sponsorships and evaluate strategic fit for events—consider frequency, ROI, and unique consumer segments to ensure differentiation and maximize impact.
- Manage logistics: permits, staffing, product delivery, and on-site setup (including tents and equipment).
Brand Ambassador Team Management
- Recruit, train, and oversee part-time Brand Ambassadors.
- Ensure compliance with brand guidelines and sampling protocols.
- Track ambassador hours, performance, and KPIs.
Cross-Functional Collaboration
- Partner with Sales on account activations, blitzes, and merchandising.
- Work closely with Marketing to report on localized campaigns and consumer insights.
Budget & Reporting
- Track budgets for sampling and events; report on performance metrics.
- Identify creative opportunities to reach new consumer profiles.
QUALIFICATIONS
- 2–5 years in field and sales marketing, event marketing, and brand ambassador management (beverage experience preferred).
- Strong organizational skills; ability to manage multiple projects.
- Proven ability to work independently in a fast-paced, remote environment.
- Excellent interpersonal and communication skills.
- Proficiency in KPI tracking and reporting.
- Clean driving record; background check required for leased vehicle use.
- Creative and resourceful in identifying local marketing opportunities.
- Results-driven with a proactive, problem-solving mindset.
- Sales experience or mindset is a plus.
Travel & Physical Requirements
- Frequent travel within region; occasional overnight stays (approx. 6-8 nights/month).
- Comfortable working nights, weekends, and holidays for events.
- Ability to lift and transport event materials (up to 50 lbs).
Driving Requirements
- Must be comfortable driving a Sprinter van as part of the role.
- Prior experience driving larger vehicles (e.g., Sprinter vans, box trucks, or similar) strongly preferred.
- Valid driver’s license required
REPORTS TO: Director, Field Marketing
COMPENSATION: $95,000-$120,000 base salary + bonus
HOW WE WORK
We may be fully remote, but we’re anything but disconnected. OLIPOP has grown from a few passionate people around a table to a nationwide team, and we’ve done it without losing our collaborative spirit or sense of purpose.
Connection here is intentional. From cross-functional projects and IRL offsites to thoughtful Slack threads and spontaneous gifs, we make the effort to stay close, even across time zones. Sure, we move quickly, but we lead with trust, transparency, and a shared commitment to doing work that matters.
We value thoughtful debate. We give feedback with care and receive it with curiosity, knowing that real growth, both personal and collective, comes from listening as much as leading. Because at OLIPOP, it’s not just about getting things done. It’s about growing together, staying true to what matters, and building something with lasting impact.
WHAT WE VALUE
At OLIPOP, our values aren’t just posters on a wall. They shape how we show up: for each other, for our customers, and for the mission we’re chasing together.
- Mission Connectivity: Everything we do ladders up to our shared goal: supporting human health. Whether launching a new flavor or conducting clinical research, the mission stays front and center.
- Indomitable Spirit: When things get messy, we get inventive. We stay curious, adapt quickly, and find the path forward, most likely with a dedicated Slack thread and a beautifully overbuilt deck.
- Lead at Every Level: Leadership isn’t about titles, it’s about ownership. We speak up, follow through, and lift each other up. If you’ve got ideas and initiative, you’ve got influence.
- Courageous Humility: We’re confident in what we bring and curious about what we don’t know (yet). We give feedback with care, take it with grace, and know that real growth takes both.
WHAT WE’RE LOOKING FOR
Success at OLIPOP doesn’t come from checking boxes; it comes from living our values, staying curious, and finding energy in both the pace and the purpose. We’re building something big, and we’re looking for people who:
- Think big, move fast, and take thoughtful risks
- Thrive in a high-performance, feedback-rich environment
- Value real human connection and honest collaboration
- Are fired up by building something new, and making it better every day
Startup life at OLIPOP is equally fun and fast-paced. If you’re energized by a dynamic environment, eager to grow, and excited to help shape something meaningful from the inside out, OLIPOP is a one-of-a-kind ride.
We are committed to providing reasonable accommodations to qualified individuals with disabilities or other needs during the application process and employment. To request an accommodation, please contact The People Team at recruiting@drinkolipop.com.
We are proud to be an Equal Opportunity Employer. OLIPOP will consider all qualified applicants without regard to race, religion, gender (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, veteran status, or any other characteristics protected by law.
Submission of Application Materials
Applicants are required to submit only the materials specifically requested as part of the application process. Please do not include any unsolicited materials, as they will not be reviewed or considered.
Unsolicited materials may include, but are not limited to:
- Marketing or promotional concepts
- Business ideas or strategies
- Photographs, videos, or other media
- Presentations, designs, or other creative content
By submitting any materials beyond those explicitly requested, you agree that:
- You are voluntarily providing such materials;
- You irrevocably assign all rights, title, and interest in and to those materials to Olipop Inc.; and
- Olipop Inc. may use, reproduce, modify, distribute, or otherwise exploit such materials for any purpose anywhere in the world, without restriction or compensation.
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Senior Clinical Trial Manager
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Your work will change lives. Including your own.
The Impact You’ll Make
Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking a highly motivated, skilled, and adaptable Clinical Trial Manager within our Clinical Operations team who will manage the conduct and execution of one or more clinical trials from study start-up to study closure in close collaboration with the Clinical Project Manager and/or Associate Director/Director of Clinical Operations.
In this role, you will:
- Support the Clinical Project Manager in the execution of trial operations across diverse therapeutic areas to deliver transformative, new medicines to patients
- Manage and track clinical trial activities, timelines, and deliverables
- Engage and build relationships with clinical CRO and trial partners to support the successful execution of clinical trial activities
- Proactively identify opportunities for operational and process improvements within the Clinical Operations team
- Contribute to the advancement of the Recursion development portfolio
The Team You’ll Join
Reporting to an Associate Director/Director of Clinical Operations, you will be an essential member of the Clinical Operations team within Development and work closely with cross-functional study teams. You will impact all phases of Development clinical trials. The team is dedicated to ensuring operational excellence across our clinical programs.
The Experience You’ll Need
- Bachelor’s degree or equivalent experience
- 6+ years of experience in a clinical operations role in the biopharmaceutical industry, with at least 2+ years experience as a regional CTM or similar operations role required
- Preferred experience: monitoring experience, automating trial activity tracking through Smartsheet or other CTMS/tracking tools
- Early phase (Phase 1, 2) oncology and/or rare disease experience at a Sponsor or CRO is required
- Strong working knowledge of FDA, ICH, GCP regulations and guidelines
- Effective collaboration in a fast-paced team environment
- Excellent interpersonal and communication skills, and an understanding of principles of relationship management across diverse internal and external stakeholders
- Detail-oriented with effective organizational and problem-solving abilities.
- Experience in managing multiple priorities and able to accomplish tasks within a timeframe, setting milestones to meet deadlines and to achieve goals
- Proficient in using various software applications related to clinical trials, such as, but not limited to: smartsheet, clinical trial management systems, project management tools, document management systems, and electronic data capture tools
- Willingness to travel to sites, conferences, and/or Recursion offices (NYC and SLC) as needed
Working Location & Compensation:
This position is open to both remote and hybrid models. The hybrid position would be office-based at either our office located in New York City, New York or Salt Lake City, Utah. Employees are expected to work in the office at least 50% of the time. Relocation support can be provided for candidates not local to either geographical location.
At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is $136,200 to $192,200. You will also be eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package.
#LI-DB1
#LI-REMOTE
The Values We Hope You Share:
- We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
- We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
- We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
- We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
- We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
- We are One Recursion. True cross-functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.
Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.
More About Recursion
Recursion (NASDAQ: RXRX) is a clinical-stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI-native, end-to-end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better, and at scale — for patients who are waiting.
Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com, or connect on X and LinkedIn.
Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
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Senior Clinical Data Manager
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Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Senior Clinical Data Manager (Sr. CDM) is responsible for leading end-to-end data management activities across one or more complex clinical trials. This role ensures high-quality, reliable clinical data that meets regulatory standards and supports timely clinical development decisions. The ideal candidate is a proactive problem solver with experience in data standards, EDC systems, and cross-functional collaboration.
Responsibilities
Study Planning & Start-Up
- Serve as the data management lead for assigned clinical studies, providing strategic input into protocol design and data collection strategy.
- Develop and manage Data Management Plans (DMPs), CRF/ eCRF specifications, edit check specifications, and data validation plans.
- Lead EDC system set-up, UAT, and deployment; coordinate with external vendors and internal biometrics teams.
Execution & Oversight
- Oversee all data review activities, including query management, data cleaning, discrepancy resolution, and ongoing data quality monitoring.
- Ensure adherence to CDISC/CDASH/SDTM standards where appropriate, as well as applicable regulatory requirements (ICH-GCP, FDA, EMA).
- Track study metrics, identifying risks and implementing mitigation strategies to maintain high-quality and timely deliverables.
- Manage interactions with CROs, central labs, imaging vendors, and other data contributors.
Close-Out & Reporting
- Lead database lock activities, ensuring audit readiness and complete documentation.
- Support statistical programming and medical writing teams in delivering data for interim analyses, CSR outputs, and regulatory filings.
- Contribute to process improvements and knowledge sharing within the data management function.
Qualifications
- Bachelor’s degree in relevant field
- A minimum of 5 years of Clinical Data Management experience in the biotech/pharma industry. Oncology experience is strongly preferred.
Knowledge and Skills
- Demonstrated expertise with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva CDMS).
- Understanding of clinical trial methodology, regulations, and data standards.
- Experience leading data management activities for Phase I–III global clinical trials.
- Vendor oversight experience and ability to drive cross-functional alignment.
- Knowledge of FDA, ICH-GCP, and 21 CFR Part 11 compliance.
- Excellent communication, documentation, and project management skills.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
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Senior EDC Programmer
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Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Senior EDC (Electronic Data Capture) Programmer (Sr. EDCP) is responsible for leading the design, development, and maintenance of clinical trial databases in an EDC system. This role will work closely with Clinical Data Management, Biostatistics, Clinical Operations, and external vendors to ensure high-quality, compliant data collection systems that support efficient trial execution.
Responsibilities
- Lead the design, build, validation, and deployment of a study build within an EDC system.
- Develop and maintain edit checks, custom functions, derivations, and integrations.
- Review study protocols and provide input on CRF design and database structure.
- Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable).
- Perform User Acceptance Testing (UAT) and support database releases and migrations.
- Ensure EDC systems comply with regulatory requirements (FDA, ICH-GCP, 21 CFR Part 11).
- Troubleshoot and resolve database issues in a timely manner.
- Oversee and/or mentor junior programmers or external vendors.
- Contribute to SOP development and process improvements.
- Support data integrations with external systems (IRT, ePRO, labs, etc.).
- Maintain documentation including specifications, validation records, and audit trails.
Qualifications
- Bachelor’s degree in relevant field.
- A minimum of 5 years of EDC programming experience in the biotech/pharma industry. Oncology experience is preferred.
Knowledge and Skills
- Strong hands-on experience with at least one major EDC platform (Medidata Rave preferred).
- Solid understanding of clinical trial processes and data flow.
- Experience with CDISC standards (SDTM, CDASH) is preferred.
- Familiarity with regulatory requirements (ICH-GCP, 21 CFR Part 11).
- Strong problem-solving skills and attention to detail.
- Ability to manage multiple studies and priorities.
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
Ready to apply?
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Senior Site Contracts Manager - FSP
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Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
Reasonable estimate of the current range for Poland: 230,200 - 287,800 PLN
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
Reasonable estimate of the current range for Poland: 230,200 - 287,800 PLN
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia, or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision for Medicine
Senior Site Contracts Manager - FSP
Share this job
Precision for Medicine is looking for a Senior Site Contracts Manager to join our FSP group in Europe. We are looking for someone with extensive site contracts and budgets experience across European region. This position can be covered fully remotely from Hungary, Poland, Romania, Serbia or United Kingdom.
Position Summary:
Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendments. Works closely with Clinical Operations study teams and plays a key role to ensure deliverables are in alignment with defined study timelines. The Senior Contracts Manager will serve as a subject matter expert within the department and company regarding site contract management..
Essential functions of the job include but are not limited to:
- Establish process and procedures for overall site contract management in the organization.
- Review, draft and negotiate a variety of agreements including site contracts, confidentiality agreements, and other client contracts. .
- Escalate and resolve complex issues with clients and internal stakeholders.
- Negotiate site budget.
- Provide guidance to business teams regarding operational implications of contract terms.
- Ensure adherence to company policies, procedures and contracting standards.
- Update relevant study team members regarding the status of contract negotiations and execution.
- Establish, track, report and manage site contract metrics.
- Coordinate execution of agreements and track agreement expirations and other obligations
- Support the maintenance of contract files and databases, including contract archiving.
- Assist in designing and implementing policies and procedures to affect the timely execution of contracts.
- Recognize where processes can be improved and take corrective action.
- Mentor and/or Ambassador for new SCMs and Precision for Medicine staff
- Other tasks, as assigned.
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree
- Equivalent experience ideally in a scientific or healthcare discipline
- Previous CRO experience
- 5+ years Oncology experience
- Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements and site Budget negotiations, but no less than 7 years’ experience.
- Experienced leading interactions with US/European/APAC or other regions institutions
- Experienced leading interactions with Study Teams and Sponsor
Preferred:
- Bachelors in law, scientific fields, business administration or equivalent degree
- Excellent organizational and communication skills and attention to detail
- Experienced on setting up Contracting Plans - Guides for CTA & Budget negotiations
- Experienced dealing with Kick-Off Meetings (KOM) and Bid Defense Meetings (BDM)
- Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines
Skills:
Competencies
- Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment.
- Executes time-sensitive matters while maintaining accuracy and attention to detail.
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Displays sound business judgment and a proactive, independent work style.
- Proficient in MS Office software programs and computer applications
- Handles sensitive issues with discretion.
- Works well independently and cooperatively with others to achieve common goals in a virtual environment.
- Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support.
#LI-Remote
#LI-TB1
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
About Loyal
Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.
We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress in our mission to develop the first FDA-approved drugs to extend canine lifespan: as of early 2026 we've completed two of three major FDA review sections for our lead program, LOY-002, and are targeting submission of the third and final section later this year.
Loyal is a well-funded startup with teams of scientists, veterinarians, engineers, operators, and creatives. You'll help us continue on our path of earning FDA approval for the first lifespan extension medicine for any species, and change what's possible for the dogs we love.
About the role
The Senior Director of Clinical Development leads the team responsible for design, execution, and strategic direction of clinical programs across Loyal’s veterinary product portfolio. This role is responsible for driving end-to-end clinical strategy, from target product profile to study design and regulatory-facing protocol development through field execution, data interpretation, and evidence package generation.
This is a highly cross-functional role that partners closely with R&D, Clinical Operations, Project Leadership, Regulatory (FDA-CVM),CMC, and Commercial to ensure our studies are scientifically sound, operationally feasible, and aligned with pathways to approval.
You will be reporting to our VP, Clinical and Veterinary Medicine .
Your daily work will include:
Clinical Strategy & Program Development
- Own the clinical development strategy for our portfolio of veterinary drug programs, including target product profiles, pivotal pathway planning, and key endpoints aligned with CVM expectations.
- Build and manage detailed timelines for product development
- Communicate strategy and development timelines across multiple teams within Loyal
Study Design & Protocol Development
- Design companion animal clinical trials (pilot, field safety, and pivotal effectiveness studies) with appropriate statistical powering, endpoint justification, inclusion/exclusion parameters, and handling of operational constraints (e.g., heterogeneous populations, compliance variability).
- Develop protocols, investigator brochures, SAP inputs, and essential documents tailored for investigators and staff in veterinary practice settings.
- Work closely with statisticians on statistical design, randomization schemes, interim analyses, and data quality plans.
- Partner with clinical operations to execute protocols with GCP compliance and serve as medical expert throughout in-life phase.
Study Execution & Medical Oversight
- Provide medical and scientific oversight for all clinical studies, including:
- Eligibility decisions
- Case reviews and AE/SAE reporting
- Protocol deviations and issue escalation
- Interpretation of clinical data trends during trial execution
- Support Clinical Operations with site engagement strategy, investigator training, and owner-facing communication frameworks.
- Partner with Veterinary Affairs on real-world applicability, disease models, and clinician feedback loops.
Regulatory Leadership (FDA-CVM)
- Lead clinical components of regulatory interactions, including:
- Pre-Submission meetings
- Technical section responses
- Study protocol reviews with regulators
- Evidence summaries for FOI packages
- Ensure that all clinical components meet VICH, GCP, and CVM guidance standards.
Cross-Functional Collaboration
- Work tightly with:
- R&D to vet new drug targets and mechanisms and interpret pre-clinical data
- Regulatory to align development plans with CVM requirements.
- Veterinary Affairs to ensure clinic workflows and veterinary input shape study design.
- Clinical Operations on execution strategy, site selection, and quality.
- Commercial to ensure label-enabling claims are supported by data.
Data Interpretation & Evidence Generation
- Lead clinical data review, analyses, and messaging strategy.
- Develop authoritative veterinary medical clinical narratives for regulatory submissions, publications, and scientific communications.
- Author study reports, abstracts and external presentations as needed.
Team Leadership
- Build and mentor a growing, high-functioning clinical development team with both veterinary medical and technical backgrounds.
- Foster a culture of scientific excellence, operational pragmatism, and veterinary investigator-centered study design
About you:
- DVM or equivalent.
- 10 -12+ years of experience in clinical development in animal health clinical development.
- Demonstrated experience designing and leading clinical trials, including protocol authorship, data review, and cross-functional collaboration.
- Prior oversight of safety evaluation, study conduct, and interpretation of clinical endpoints.
- Strong understanding of evidence requirements for regulatory approval.
- Ability to lead in a fast-paced, high-accountability biotech environment.
Required
- Direct experience with FDA-CVM VICH guidelines.
- Experience in companion animal medicine, bonus if experience is in aging/longevity or quality-of-life endpoints.
- Background working with veterinary clinics, practice networks, or decentralized trial models.
Salary range: $230,000 - $270,000
Loyal benefits
- Full-coverage health insurance — medical, dental and vision — for you and your dependents
- $1,000 home office equipment stipend
- $1,200/year learning budget for books, courses, etc.
- $250/month wellness budget for gym, cleaners, spa, food, etc.
- All 3-day weekends are turned into 4-day weekends 🎉
- Unlimited vacation and paid holidays
- Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
- Competitive salary
- Company equity options grant for new hires
Loyal is founded and led by a first-gen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.
Our values
Lean into moonshots
We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have.
Opportunity is at the intersection
We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.
Expertise without ego
Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it.
Learning by doing
Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes.
Lead with context
We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed.
Empathy and respect for all life
Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.
Ready to apply?
Apply to Loyal
Manager, Global Clinical Monitoring
Share this job
Position Summary:
- The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
- This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction
Essential functions of the job include but are not limited to:
- Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
- Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
- Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
- Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
- Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
- Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
- Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
- Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
- Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency, and efficiency in execution.
- Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
- Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
- Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas.
- Represent Precision for Medicine in a professional manner
- Manage CRA staff in accordance with Precision for Medicine’s values and policies.
- Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.
- Perform other duties as assigned by Leadership
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
Other Required:
- At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
- Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
- 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:
- Experience creating effective development programs for clinical staff.
- Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards
- Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.
Preferred:
- Experience in the Therapeutic area/country of the staff assigned to manage
Skills:
Competencies:
- Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
- High capacity for Emotional Intelligence and a passion for people management and development.
- As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
- Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
- Demonstrates understanding and ability to work with EMRs and EDCs
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Motivates other members of the project team to meet timelines and project goals.
- Highly organized, ability to set priorities and possesses excellent problem-solving skills.
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
- Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Ability to develop, coach and mentor CRA staff.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Communicates both verbally and in written form in an acceptable manner.
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
- Possesses practical knowledge of IT tools and systems in use on project teams.
- Values system and work ethic consistent with Precision Values and Company Principles
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
Ready to apply?
Apply to Precision Medicine Group
Manager, Global Clinical Monitoring
Share this job
Position Summary:
- The Manager Global Clinical Monitoring (GCM) offers an additional development path for clinical research professionals. Responsibilities are focused on the management and career development of the organization’s Clinical Research Associate (CRA) workforce as well as supporting the development of departmental initiatives to strengthen the quality and productivity of GCM operations.
- This position requires the ability to independently lead, manage, and motivate a team of CRAs (employee and/or consultant) to a standard consistent with Precision for Medicine’s values and overall focus on quality. Specific focus will be to ensure the right resources are assigned to projects and that those resources have the tools necessary to be successful. In addition, this position will provide the CRAs with career development and support, to minimize turnover and maintain high levels of employee satisfaction
Essential functions of the job include but are not limited to:
- Generate action plans and provide developmental/strategic oversight to optimize CRA services, with a focus on high quality delivery of individual/team/departmental goals.
- Assist with and contribute to project resourcing to ensure proper level and allocation resource is assigned for each project within their hierarchy (with respect to project phase). Update tracking systems and interface with project teams.
- Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
- Develop, mentor, manage and coach CRA staff to progress their skills so that Precision for Medicine quality standards are maintained. Advocate individual career development, and individual responsibility/accountability.
- Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project specific issues.
- Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
- Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
- Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
- Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency, and efficiency in execution.
- Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
- Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
- Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training and other functional areas.
- Represent Precision for Medicine in a professional manner
- Manage CRA staff in accordance with Precision for Medicine’s values and policies.
- Secondary responsibilities include assisting with the planning, assigning, and directing of work as well as gathering performance feedback to contribute to appropriate action plans.
- Perform other duties as assigned by Leadership
Qualifications:
Minimum Required:
- Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline
Other Required:
- At least 7 years or more in clinical operations, data management or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
- Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
- 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:
- Experience creating effective development programs for clinical staff.
- Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision for Medicine quality standards
- Ability to drive and availability for domestic and international travel including overnight stays, with an expectation of travel approximately 25%.
Preferred:
- Experience in the Therapeutic area/country of the staff assigned to manage
Skills:
Competencies:
- Demonstrates mastery knowledge of ICH-GCP, applicable local regulatory requirements, relevant Precision for Medicine SOPs, technical CRA knowledge of all phases of study (including remote monitoring and clinical data review) as well as regulatory guidance.
- High capacity for Emotional Intelligence and a passion for people management and development.
- As part of overall line management responsibilities, ability to develop training plans and hold personnel accountable to achieving training goals or addressing training needs
- Deep knowledge of how clinical research centers operate along with the ability to teach CRAs to solve site and execution related problems at the site level.
- Demonstrates understanding and ability to work with EMRs and EDCs
- Exhibits high self-motivation and is able to work and plan independently as well as in a team environment.
- Motivates other members of the project team to meet timelines and project goals.
- Highly organized, ability to set priorities and possesses excellent problem-solving skills.
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective.
- Understands clinical trials methodology, including a working knowledge of protocols and indications being studied.
- Ability to develop, coach and mentor CRA staff.
- Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills.
- Communicates both verbally and in written form in an acceptable manner.
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency.
- Possesses practical knowledge of IT tools and systems in use on project teams.
- Values system and work ethic consistent with Precision Values and Company Principles
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
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Vice President, Development Data Science
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Why Join Us?
As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.
Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered “undruggable” despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and ARON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.
What’s the opportunity?
The VP, Development Data Science will build and lead a cross functional data centric matrix to accelerate drug development, support regulatory submissions and guide the Real-World Data (RWD) / Real-World Evidence (RWE) function at Parabilis. This role is responsible for end-to-end strategy and execution of RWD/RWE and clinical data science to inform trial design, contextualize clinical results, support biomarker and translational work, and optimize site and patient selection.
The VP will partner closely with Clinical Development, Clinical Operations, Biostatistics, Translational/Computational Biology, Regulatory, and the broader Data Science & Engineering team to maximize the probability of success of our clinical programs.
- Strategy & Leadership
- Define and own the Clinical Data Science strategy.
- Serve as the senior Clinical Data Science leader and primary point of contact for RWD/RWE across programs aligned with portfolio and corporate objectives.
- Represent Clinical Data Science on cross-functional governance and portfolio forums.
- RWD/RWE & Clinical Analytics
- Design and oversee RWE studies to contextualize clinical trials, including synthetic/external control arms, patient matching, and trial emulation.
- Use RWD to inform clinical trial design (eligibility criteria, endpoints, enrichment strategies), dose/regimen selection, and go/no-go decisions.
- Contribute data science insights for feasibility and site selection, including epidemiology, patient journeys, referral patterns, and diversity/access.
- Integrate RWD with internal clinical and biomarker data to support forward and reverse translation, target and indication strategy, and mechanism-of-resistance analyses.
- Establish and maintain best practices in causal inference, comparative effectiveness, and time-to-event modeling relevant to RWE in oncology.
- Data Assets, Partnerships & Infrastructure
- Identify, evaluate, and prioritize RWD sources (EHR, claims, registries, genomic/omic datasets, imaging, PROs) to support current and future clinical needs.
- Lead collaboration and contracting with RWD providers and academic/industry partners in coordination with Commercial, Business Development, Legal, and Procurement.
- Partner with Engineering and Data Science to define requirements for secure, scalable, compliant RWD infrastructure and analytic environments.
- Ensure data quality, interoperability, and governance suitable for regulatory-grade analyses.
- Team Building & Management
- Build and lead a high-performing Clinical Data Science team (e.g., RWE epidemiologists, clinical data scientists, etc).
- Set clear objectives, provide regular feedback, and support growth and succession planning.
- Foster a culture of scientific rigor, transparency, and effective collaboration with Clinical Development, Biostatistics, and other partners.
- Cross-Functional Collaboration & Communication
- Work in an integrated way with Clinical and Development teams to define key questions and translate them into analytic and RWE plans.
- Communicate complex methods, assumptions, and results clearly to clinical, technical, and executive stakeholders.
- Support regulatory and payer/Health Technology Assessment interactions where RWE and clinical analytics contribute to program strategy (e.g., briefing documents, responses, meeting preparation).
- Collaborate with Translational and Computational Biology to align biomarker and patient selection strategies with integrated clinical and RWD analytics.
- Governance, Quality & Compliance
- Ensure RWD/RWE activities meet regulatory, ethical, and privacy standards (e.g., GCP, data de-identification and privacy requirements).
- Implement documentation, reproducibility, and quality standards for Clinical Data Science analyses.
- Monitor evolving external expectations for use of RWE in regulatory and payer settings and adapt internal practices accordingly.
What you’ll need to be successful:
- PhD, MD, PharmD, or MS in Epidemiology, Biostatistics, HEOR, Data Science, or a related quantitative field.
- 12–15+ years of experience in pharma/biotech, healthcare technology, or related sectors, with significant focus on RWD/RWE and clinical development; oncology experience strongly preferred.
- Proven track record designing and delivering impactful RWE studies to inform clinical, regulatory, or payer decision-making.
- Strong understanding of clinical trial design, biostatistics fundamentals, and translational/biomarker concepts, ideally in oncology or immuno-oncology.
- Demonstrated experience building, leading, and developing high-performing quantitative teams in a matrixed environment.
- Hands-on familiarity with major RWD types (EHR, claims, registries, genomic/omic datasets) and key vendors/platforms.
- Proficiency with modern analytic tools and programming environments (e.g., R, Python, SQL) and with guiding development of robust, reproducible analytic workflows.
- Excellent communication and influencing skills with the ability to engage effectively with clinicians, statisticians, senior leaders, and external partners.
Core Values
Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.
- Growth-Minded. We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
- In(ter)dependent. We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
- Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
- All-In. We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.
The base salary range for this position is $325,000-$380,000 per year, depending on experience, qualifications, and internal practices. Parabilis’s total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees’ overall well-being.
As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com
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Clinic Supervisor (RN)
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At Habitat Health, we envision a world where older adults experience an independent and joyful aging journey in the comfort of their homes, enabled by access to comprehensive health care. Habitat Health provides personalized, coordinated clinical and social care as well as health plan coverage through the Program of All-Inclusive Care for the Elderly (“PACE”) in collaboration with our leading healthcare partners, including Kaiser Permanente.
Habitat Health offers a fully integrated experience that brings more good days and a sense of belonging to participants and their caregivers. We build engaged, fulfilled care teams to deliver personalized care in our centers and in the home. And we support our partners with scalable solutions to meet the health care needs and costs of aging populations.
Habitat Health is growing, and we’re looking for new team members who wish to join our mission of redefining aging in place. To learn more, visit https://www.habitathealth.com.
Role Scope:
- Supervise daily clinic operations within the PACE clinic, ensuring high-quality, participant-centered care
- Assign duties, mentor nursing staff, and provide clinical guidance during shifts
- Responsible for clinic performance excellence inclusive of clinic team coaching, adherence to clinical process flows / standard operating procedures and annual team evaluations
- Manage clinic staff schedules to maintain coverage
- Monitor supply levels and handle day-to-day operational needs including vendor management, supply ordering, and facility/equipment issues
- Ensure adherence to quality and compliance standards of Habitat Health and other regulatory agencies
- Provide clinical care as needed such as nurse triage, emergency response, vaccine and medication administration, wound care, home care, and patient education
Qualifications:
- Must hold a current, unrestricted RN license in state of California
- Proven ability to lead nursing teams, delegate tasks, and manage clinic operations
- Experience in staff scheduling, conflict resolution, and mentoring is essential
- Experience with geriatric population, chronic conditions, dementia, and functional decline is ideal
- Knowledge of clinical quality and compliance standards
- Ability to identify problems, find root causes, and trial/evaluate solutions
- Aligns with our purpose and our values, and is excited about living those out in daily practice
- Ability to lead with influence
Nice to have:
- Spanish fluency, ideally certified in medical translation
Compensation:
We take into account an individual’s qualifications, skillset, and experience in determining final salary. This role is eligible for medical/dental/vision insurance, short and long-term disability, life insurance, flexible spending accounts, 401(k) savings, paid time off, and company-paid holidays. The expected salary range for this position is $110,000 - $130,000 and is bonus eligible. The actual offer will be at the company’s sole discretion and determined by relevant business considerations, including the final candidate’s qualifications, years of experience, skillset, and geographic location.
Vaccination Policy, including COVID-19
At Habitat Health, we aim to provide safe and high-quality care to our participants. To achieve this, please note that we have vaccination policies to keep both our team members and participants safe. For covid and flu, we require either proof of vaccination or declination form and required masking while in participant locations as a safe as an essential requirement of this role. Requests for reasonable accommodations due to an applicant’s disability or sincerely held religious beliefs will be considered and may be granted based upon review. We also require that team members adhere to all infection control, PPE standards and vaccination requirements related to specific roles and locations as a condition of employment.
Our Commitment to Diversity, Equity, and Inclusion:
Habitat Health is an Equal Opportunity employer and is committed to creating a diverse and inclusive workplace. Habitat Health applicants are considered solely based on their qualifications, without regard to race, color, religion, creed, sex, gender (including pregnancy, childbirth, breastfeeding or related medical conditions), gender identity, gender expression, sexual orientation, marital status, military or veteran status, age, national origin, ancestry, citizenship, physical or mental disability, medical condition, genetic information or characteristics (or those of a family member), or other status protected by applicable law.
Habitat Health is committed to the full inclusion of all qualified individuals. In keeping with our commitment, Habitat Health will take steps to provide people with disabilities and sincerely held religious beliefs with reasonable accommodations in accordance with applicable law. Accordingly, if you require a reasonable accommodation to fully participate in the job application or interview process, to perform the essential functions of the position, and/or to receive all other benefits and privileges of employment, please contact us at careers@habitathealth.com.
Beware of Scams and Fraud
Please ensure your application is being submitted through a Habitat Health sponsored site only. Our emails will come from @habitathealth.com email addresses. If you feel that you have been the victim of a scam such as this, please report the incident to the Federal Trade Commission by selecting the ‘Rip-offs and Imposter Scams’ option: https://reportfraud.ftc.gov/#/.
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Clinical Research Coordinator II, Nurse
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Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Research Coordinator II - Nurse
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced Clinical Research Coordinator - Level II (CRC II). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
- Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management. Able to manage an increased number of studies and/or more complex studies
- Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies
- Schedule all patient research visits and procedures consistent with protocol requirements
- Conduct patient visits as outlined within each study protocol
- Dispense study medication, collect vital signs and perform ECGs
- Perform blood draws, process and ship specimens per study protocol and IATA regulations
- If assigned, place IVs, administer IV medication, and fluids according to protocol. Monitor patients’ IV medications and tubing. Give intramuscular and subcutaneous injections according to protocol. Monitor patients during infusion and discharge patients as policies indicate.
- Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
- Act as point of contact for study participants
- Adhere to Research SOPs, Good Clinical Practices, and the study protocols
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
- Ensure all safety data is reviewed by the PI in a timely manner
- Maintain inventory of study equipment and supplies onsite at all times
- Participate actively in communication of status and results to management; contribute and implement ideas to improve site performance
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Meet requirements for data query resolution times and quality
- Schedule and prepare for monitor visits
- Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
- Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
- Perform quality work within deadlines with or without direct supervision
- Interact professionally with other employees, customers and suppliers
- Work effectively as a team contributor on all assignments
- Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
- Registered Nurse
- Solid nursing background, concentration, or willingness to obtain advanced knowledge in GI specialty
- Minimum 3 years of clinical research experience
- Ability to own issues and problem solve independently
- Experience in phlebotomy preferred
- Strong written and verbal communication skils
- Ability to read, interpret, and apply clinic policies and research protocols
- Ability to use standard office software
- Must be able to lift up to 25 pounds
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Ready to apply?
Apply to Iterative Health
Clinical Research Coordinator I
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Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Clinical Research Coordinator I
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 80+ global clinical research sites accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
We are seeking a full-time, experienced Clinical Research Coordinator (CRC). The CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
Responsibilities:
- Administratively and clinically manage industry-sponsored clinical trials including problem solving, communication and protocol management.
- Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation
- Schedule all patient research visits and procedures consistent with protocol requirements
- Conduct patient visits as outlined within each study protocol
- Dispense study medication, collect vital signs and perform ECGs
- Perform blood draws, process and ship specimens per study protocol and IATA regulations
- Ensure relevant study and subject specific information is entered into the CTMS system on a regular basis; complete and maintain documentation study files including, but not limited to, consent forms, source documentation, progress notes if applicable, case report forms, and investigational accountability forms.
- Act as point of contact for study participants
- Adhere to Research SOPs, Good Clinical Practices, and the study protocols
- Maintain ongoing communication with the CRO, sponsor, research participants, Site Manager and PI throughout course of the study
- Ensure all safety data is reviewed by the PI in a timely manner
- Maintain inventory of study equipment and supplies onsite at all times
- Participate actively in communication of status and results to management
- Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol
- Schedule and prepare for monitor visits
- Assists Study Team in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations
- Cooperates with site compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance
- Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
Iterative Health Expectations
All employees are expected to:
- Perform quality work within deadlines with or without direct supervision
- Interact professionally with other employees, customers and suppliers
- Work effectively as a team contributor on all assignments
- Work independently while understanding the necessity for communicating and coordinating work efforts with other employees and organizations
Qualifications
- Medical Assistant, LPN, Associates or Bachelor’s degree in a clinical or scientific-related discipline preferred
- Minimum 1-2 years of clinical research experience
- Able to execute on research tasks with guidance from more experienced staff, PIs, and management
- Strong written and verbal communication skils
- Ability to read, interpret, and apply clinic policies and research protocols
- Ability to use standard office software
- Must be able to lift up to 25 pounds
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
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Apply to Iterative Health
This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.
The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.
PRIMARY RESPONSIBILITIES:
-
Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.
-
Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.
-
Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
-
Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor. Collaborate on manuscripts for publications.
QUALIFICATIONS:
-
Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
-
4+ years of experience in clinical trial biostatistics.
-
Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
-
Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
-
Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
-
Proficient in R.
KNOWLEDGE, SKILLS, AND ABILITIES:
-
Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.
-
Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.
-
Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.
-
Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.
Preferred qualifications:
- Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
- Experience with non-inferiority studies.
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Ready to apply?
Apply to Natera
This is an exciting opportunity for a highly experienced, independent clinical biostatistician to advance adoption of Natera’s oncology portfolio of cutting-edge molecular diagnostic tests. As a Lead Biostatistician, you will independently lead the design, analysis, and reporting for multiple practice-changing oncology clinical trials. You will propose efficient, fit-for-purpose study designs with broad impact across the oncology portfolio.
The ideal candidate brings deep statistical expertise, strong scientific communication skills, and a proven track record of applying innovative methodologies to oncology clinical trial design in a fast-paced, cross-functional environment.
PRIMARY RESPONSIBILITIES:
-
Study Design and Statistical Strategy: Lead the statistical design and analytical planning for oncology clinical utility studies. Provide technical expertise in complex study design methodologies and data analyses. Propose and justify efficient study designs tailored to complex oncology use cases.
-
Cross-Functional Collaboration: Serve as study statistician for multiple studies. Collaborate with clinical, medical, and translational partners to influence study planning, development, and execution. Identify risks, proactively communicate concerns, and champion solutions to interdisciplinary teams and executive leaders.
-
Documentation and Reporting: Author and review high-quality statistical deliverables, including statistical analysis plans (SAPs), and reports (TLFs, CSRs, publications) for cross-functional collaborators and stakeholders.
-
Innovation and Improvement: Recommend and apply novel statistical approaches where appropriate. Mentor early career statisticians and support continuous improvement of departmental processes, tools, and templates to enhance team efficiency and analytical rigor. Collaborate on manuscripts for publications.
QUALIFICATIONS:
-
Advanced degree in Biostatistics, Statistics, or a related quantitative field (Ph.D. preferred).
-
4+ years of experience in clinical trial biostatistics.
-
Strong expertise in time-to-event analysis, including handling of censoring, competing risks, and advanced survival modeling approaches commonly used in oncology.
-
Expertise with innovative study design (e.g. adaptive and biomarker-informed designs), power calculations, and endpoint evaluation.
-
Working knowledge of ICH and GCP guidelines as well as CDISC standards (e.g. SDTM, ADaM).
-
Proficient in R.
KNOWLEDGE, SKILLS, AND ABILITIES:
-
Expert-level ability to independently design clinical studies, grounded in deep domain knowledge and a nuanced understanding of complex, oncology-specific challenges.
-
Experience with biomarker enabled clinical study designs, sample size determination, and endpoint evaluation.
-
Demonstrated ability and enthusiasm for working in fast-paced, cross-functional environments with collaborators from diverse technical backgrounds.
-
Ability to communicate complex statistical concepts clearly to both technical and non-technical audiences.
Preferred qualifications:
- Working-knowledge of NGS-based diagnostics and ctDNA/MRD.
- Experience with non-inferiority studies.
Compensation & Total Rewards
This range reflects a good-faith estimate of the base pay we reasonably expect to offer at the time of hire. Final compensation will vary based on experience, qualifications, and internal equity considerations.
This position is also eligible for additional compensation and benefits through Natera’s robust Total Rewards program, including:
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Annual performance incentive bonus
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Long-term equity awards
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Comprehensive health benefits (medical, dental, vision)
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401(k) with company match
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Generous paid time off and company holidays
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Additional wellness and work-life benefits
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Ready to apply?
Apply to Natera
Real World Evidence/HEOR Contractor
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Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
This Real World Evidence (RWE)/Health Economics (HEOR) Contractor role supports the RWE/HEOR Senior Director in leading RWE execution for pipeline assets. The role is fun and flexible with a mix of both study execution and data analytics. This person will be accountable for developing and delivering components of the evidence generation plan (including RWE and economic value evidence), and driving high-quality deliverables that inform internal decision-making during product development, pre-launch readiness, and lifecycle planning. The role is anchored to 1–2 priority pipeline assets/indications.
This is a remote role based with flexible hours. We are currently seeking an individual with 20-30 hours of weekly availability with potential to increase hours in late 2026/2027.
Responsibilities
- Evidence strategy and planning: Maintain US RWE & HEOR plans for 1–2 priority pipeline assets/indications, aligned to US medical, payer, and access needs; translate strategy into actionable workplans, timelines, and resourcing proposals.
- Study leadership (RWE/HEOR): Own day-to-day leadership for assigned real-world evidence and health outcomes studies (e.g., real-world evidence studies, cost-effectiveness/budget impact analyses, burden of illness, treatment patterns, patient-focused outcomes) including design and execution in partnership with internal functions and external vendors.
- Scientific communication and quality: Draft/review project specifications, protocols, statistical analysis plans, study reports, abstracts, posters, and manuscripts; ensure adherence to SOPs and high scientific/operational quality.
- Analytic execution and statistics: Execute ad hoc analyses in clinical trial, claims and PCOR data as needed for ad hoc and protocol/SAP driven analyses. This may include feasibility or full protocol execution.
- Governance, compliance, and capability building: Complete required training, adhere to company/department SOPs, and contribute to continuous improvement of processes that enable efficient planning, execution, and dissemination of RWE & HEOR deliverables.
Required Qualifications
- Master’s degree or PhD in epidemiology, health economics and outcomes research, public health, biostatistics, or related discipline.
- At least 1+ years of experience in the pharmaceutical industry and/or managed care, hospital, academic, or healthcare consulting environment with exposure to HEOR/RWE strategy and application
- Proficiency with SAS and/or R for statistical programming. Preference for experience in clinical trials OR claims data.
- Expertise in RWE and study designs/methods evidenced by publications and/or contributing to study concept sheets and protocols, reviewing/authoring key sections of statistical analysis plans and study reports, and ensuring publication/disclosure readiness in accordance with ICJME criteria
- Strong communication and presentation skills, demonstrated by developing and presenting clear, decision-oriented materials (e.g., evidence strategy slides, executive readouts) and summarizing outcomes/next steps for senior audiences
Preferred Qualifications
- Demonstrated success developing and executing health outcomes research plans and delivering high-quality data generation outputs.
- Experience managing real-world data sources and vendors (e.g., claims, EHR, registries) and translating findings into actionable insights and value messages.
- Demonstrated ability to influence without authority in a matrix environment, evidenced by aligning cross-functional stakeholders on objectives/trade-offs, documenting decisions, and driving actions to closure.
- Experience in PCOR implementation and validation
Work Location and Condition
- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Hawaii, Michigan and Tennessee.
- You must have access to work in setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communication via video conference, etc.) at your remote location
Compensation
The hourly pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Sr. Product Manager - Data & Applied AI (Patient Experience & Commercial Operations Focus)
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Role Overview
We are seeking a Sr. Technical Product Manager to lead the strategy and execution of data product, AI/ML system, AI-powered tooling, and automation initiatives across Patient Experience and Commercial Operations functions. This role is focused on improving how patients navigate testing and billing while enabling operational teams to efficiently progress cases from order to completion. You will play a crucial part in supporting initiatives to reduce friction, improve patient trust, and increase operational efficiency, ultimately driving better conversion, collections, and experience.
This role focuses on building, scaling, and leveraging platforms and products that power decision intelligence and activity orchestration across these domains. You will work in close collaboration with domain leaders while building through centralized Data & AI organization platforms, standards, and governance. You will own the full product lifecycle from discovery through production, ensuring solutions are adopted, trusted, and deliver measurable business impact. In doing so, you will work hands-on as an empowered builder of AI and software solutions to improve workflow efficiency, productivity, and quality for the teams you support.
This is a technical product role requiring fluency in data systems, modern data platforms, ML, and AI implementation patterns (and the ability and drive to build with them directly), combined with strong experience and stakeholder intuition across the associated functions. The role has direct ownership of high-impact initiatives that deeply influence organizational success.
What You’ll Do
Strategy & Roadmap
- Define and own the Data & AI product strategy and roadmap for the Patient Experience + Commercial Operations pod by deeply partnering with business leaders to proactively identify high-impact opportunities, shape problem definitions, and drive aligned priorities
- Translate ambiguous business problems (e.g., stuck cases, fragmented patient communication, support inefficiencies, billing friction) into clear product direction and measurable outcomes
- Own the line between 'what the business needs' and 'what gets built' end-to-end
Discovery, Experimentation, & Requirements
- Develop deep context on the domain so you can proactively propose solutions rather than field requests
- Be hands-on with data: query datasets, review schemas, and validate assumptions through analysis
- Lead end-to-end product discovery with interviews, workflow mapping, data assessments, ROI modeling, etc.
- Define clear product requirements (PRDs, user stories, acceptance criteria) and success metrics
- Design and run experiments to validate product performance and measure causal impact
- Establish leading indicators and KPIs for proactive product and process health assessments
Delivery, Data, & ML Lifecycle
- Partner with data and AI/ML engineering resources to deliver scalable products and capabilities
- Guide development of robust data pipelines and unified data models (360° views across key entities)
- Own the end-to-end ML lifecycle: feature definition, evaluation, deployment, monitoring, drift detection, and retraining
- Ensure training–serving consistency, model versioning, and clear deployment decision gates
- Establish strong observability across data pipelines and models (data quality, latency, reliability, cost)
AI Productization & Hands-On Building
- Define and implement AI product patterns, including agentic workflows and tool/function-calling integrations
- Build process automations and internal tools that improve workflow efficiency, productivity, and output quality for the teams you support
- Establish evaluation frameworks for LLM-powered features (faithfulness, relevance, safety, cost, latency)
- Implement prompt strategies, guardrails, and continuous evaluation pipelines
Governance, Compliance, & Data Quality
- Ensure products meet regulatory and compliance requirements
- Champion data quality, lineage, and reliability through data contracts and observability standards
- Maintain strong documentation practices (e.g., model cards, dataset documentation, audit trails)
- Partner with governance teams (Security, Legal, Compliance, AI Governance) to operationalize AI responsibly
Adoption, Change Management, & Impact
- Launch products with supporting enablement activities to ensure solutions are embedded in workflows with confidence
- Partner with stakeholders to integrate products into proactive, day-to-day decision-making
- Monitor product usage, performance, and business outcomes to iterate based on data and feedback
- Quantify and communicate impact (e.g., revenue lift, cost reduction, cycle time improvements, case completion turnaround)
- Influence Patient Experience and Commercial Operations stakeholders through delivery, not authority
Qualifications
Required
- 7+ years of relevant experience (e.g., product management, applied AI/ML engineering, technical founder, forward-deployed engineering), including 3+ years building data products, AI/ML systems, or related platforms
- Demonstrated domain fluency in Patient Experience and/or Commercial Operations
- Strong understanding of patient journeys, support channels (e.g., chat, voice, call centers), and operational workflows that drive conversion and test completion
- Familiarity with key domain-relevant tooling (e.g., patient portals, support platforms) and associated data
- Strong technical capability (e.g., comfortable scripting, performing EDA, with AI-aided application development)
- Hands-on experience shipping LLM-powered features or automations (e.g., prompting, RAG, tool/function calling, agentic orchestration, evals)
- ML/MLOps literacy (evaluation metrics, experimentation, feature stores, CI/CD, monitoring, drift)
- Familiarity with modern data stacks (e.g., Snowflake, dbt, AWS/SageMaker, Airflow/Dagster)
- Strong stakeholder leadership and communication skills, with the ability to work across technical and business teams
- Experience working in regulated environments (e.g., healthcare, life sciences, fintech)
Preferred
- Experience in healthcare, diagnostics, life sciences, and/or digital health
- Familiarity with healthcare data domains and systems, including patient, provider, payer, claims, billing, and clinical trial data
- Experience with vendor evaluation, platform selection, or external AI tooling ecosystems
- Advanced degree in a technical and/or business discipline
What Success Looks Like
- Production-grade data and AI products are deployed and embedded in day-to-day decision-making workflows
- Process automations and internal tools you build are reducing manual effort and improving output quality across the teams you support
- Measurable improvements seen in key business metrics (e.g., case completion turnaround time, patient satisfaction, cost-to-serve)
- Reliable, high-quality data foundations connect patient, provider, clinical, operational, and billing/financial insights end-to-end
- AI systems are continuously monitored, evaluated, and improved with measurable business impact
- Stakeholders trust and adopt implemented solutions across both corporate and business-unit teams
- Internal teams have transparent access to the function's roadmap, trust in delivery against it, and visibility into the evaluation logic that prioritizes initiatives based on their impact to organizational goals
OUR OPPORTUNITY
Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.
The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
WHAT WE OFFER
Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!
For more information, visit www.natera.com.
Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.
All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.
If you are based in California, we encourage you to read this important information for California residents.
Link: https://www.natera.com/notice-of-data-collection-california-residents/
Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.
For more information:
- BBB announcement on job scams
- FBI Cyber Crime resource page
Ready to apply?
Apply to Natera
Contracts and Legal Systems Manager
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Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.
What You’ll Do:
An exciting new opportunity has opened up for a Contracts and Legal Systems Manager to assist with our day-to-day legal systems and contracting needs, including for clinical trials, supply, commercial, finance, and other key contracting areas. Reporting to the Company’s Sr. Director, Corporate Counsel, this individual will play a key role in a growing legal team, with many opportunities to grow their career with the company.
The ideal candidate should have significant experience working with contracts management systems, including acting as the key legal point of contact for business users, training clients, and managing contracts workflows within a cross-functional team. The ideal candidate should also have significant experience drafting, negotiating, and managing agreements for clinical and commercial-stage pharmaceutical and life sciences companies, including non-disclosure agreements, master services agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements, and other commercial agreements. Experience as a corporate paralegal or legal support analyst at life sciences companies or law firms is considered a plus.
The successful candidate must be able to take ownership of the legal function’s role in a company’s legal, procurement, and financial systems architecture, as well as work independently to draft, revise and negotiate agreements, with a flexible and collaborative approach.
Responsibilities:
- Be responsible for the operation and administration of the company’s contract management system, acting as the key point of contact for the business
- Coordinate and assist in developing policies, procedures and systems to support and facilitate efficient contract development and analysis
- Draft, review and negotiate a variety of day-to-day contracts, including non-disclosure agreements, master service agreements, consulting agreements, manufacturing and supply agreements, clinical trial agreements and other clinical documents, independently and with limited supervision
- Negotiate to conclude agreements as efficiently as possible while meeting client needs and safeguarding MapLight’s interests
- Effectively manage outside vendors, including working with and supervising outside counsel, as required
- Create, improve, and implement applicable forms, templates, processes, and procedures to improve efficiency
- Obtain and maintain a strong working knowledge of the Company’s business, scientific capabilities, and key strategic business objectives
Other Skills and Abilities:
- Solid business judgment and strategic thinking. Ability to recognize risk and develop practical, workable strategies to mitigate such risk
- Flexibility and willingness to work on a broad variety of matters
- Strong written and oral communications skills required to work both internally and externally.
- Ability to independently work with minimal day-to-day oversight
- Ability to meet deadlines while managing a substantial workload in a fast-paced environment
- Ability to engender confidence when advising clients at all levels
- Ability to work with the highest level of integrity
- Willingness to travel when required
Qualifications:
- Bachelor’s degree with a minimum of 5 years of progressive responsibility with recent experience in contract negotiation, administration and/or management
- Experience with pharmaceutical and life sciences companies
- Familiarity with design and administration of contracts management systems (e.g., Ariba, Coupa, Concur, NetSuite)
- Paralegal certification or equivalent legal education or training is considered a plus
- Comprehensive computer skills including Microsoft Office
Key MapLight Behaviors:
We consider these behaviors we seek in all MapLight employees.
- You can participate and work effectively with multiple cross-functional teams.
- You have strong interpersonal skills and understand relationships are key to being successful.
- You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Location: Candidates for this role must be within commuting distance of MapLight’s Burlington, MA office.
Travel: Minimal travel (1-2 times per year) is expected.
Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave.
EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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Legal Operations Manager, Contracts & Privacy
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Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Legal Operations Manager, Contracts & Privacy as part of the Legal team based in Bridgewater, NJ.
Role Overview
The Legal Operations Manager, Contracts & Privacy supports the Legal Department by managing day-to-day contract lifecycle administration, coordinating operational aspects of the company’s Global Privacy program and assisting with legal operations processes and tools. This role is highly execution-oriented and works closely with attorneys and cross-functional partners to ensure efficient, compliant, and well-organized legal workflows in a fast-paced biotech environment. The position will coordinate closely with Legend Biotech’s Chief Privacy Officer and reports to Legend Biotech’s Deputy General Counsel.
Key Responsibilities
Contract Lifecycle Administration
- Coordinate the end-to-end contract process, including intake, routing, approvals, execution, and filing
- Maintain and update contract records in the company’s CLM system, ensuring accuracy and completeness of data
- Ensure contracts comply with company standards, regulatory requirements, and approval processes
- Populate basic contract template agreements (e.g. NDAs, consulting agreements, etc.)
- Track contract status, key dates (e.g., expirations, renewals), and obligations
- Assist in maintaining contract templates, standard forms and clause libraries
- Respond to internal inquiries regarding contract status and process
- Perform other contracts-related activities and tasks as assigned
Privacy Program Support
- Support day-to-day operations of the company’s Global Privacy program
- Assist with privacy impact assessments, security risk assessments and other privacy reviews and documentation
- Maintain records related to data processing activities and ensure compliance with data subject right requests
- Help coordinate privacy training, awareness initiatives and policy updates
- Track and escalate privacy-related issues and requests to appropriate stakeholders
- Organize and coordinate privacy champions meetings to ensure privacy requirements are understood and implemented
- Coordinate implementation of data mapping plan to maintain up to data inventory, liaising with system/business owners, and assist with other EU GDPR operational matters
- Track key privacy metrics (e.g., breaches report, PIAs conducted, DSARs received)
- Assist with clinical trial privacy matters, including informed consent (ICF) updates, investigator/HCP notice, and related matters
Legal Operations Support
- Maintain organized legal files, databases, and corporate records
- Support subsidiary management across US & EU jurisdictions
- Support reporting efforts by compiling basic KPIs, metrics and data for the Legal Team
- Assist with invoice processing and vendor onboarding as needed
- Support implementation and ongoing management of legal systems and tools
Requirements
- Bachelor’s degree or equivalent experience required
- 4+ years of experience in legal coordination, contract administration, paralegal support or legal operations
- Experience with contract management systems or similar tools strongly preferred
- Basic familiarity with data privacy concepts and regulations (e.g., GDPR, CCPA, HIPAA) is a plus
- Strong organizational and administrative skills with high attention to detail and accuracy
- Ability to manage multiple tasks and deadlines effectively
- Effective communication and responsiveness
- Ability to follow established processes and identify opportunities for improvement
- Comfort working with systems, data and cross-functional teams
#Li-FB1
#Li-Hybrid
The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
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Senior Manager, Clinical Trial Materials
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Position Summary:
In support of clinical development programs, the Senior Manager of Clinical Trial Materials role oversees Clinical Trial Material (CTM) planning and execution activities, supporting Phase 1-IV and IIS trials. Includes demand forecasting, determination of an appropriate presentation, setting production schedules, protocol review, ensures label compliance with applicable regulations, establishes optimal packaging & distribution strategies, tracks and reconciles drug supplies and monitors product re-test dates. Interface with internal departments and contract research organizations (CROs) as necessary to coordinate the execution of these activities. Implements and ensures group compliance to procedures for the production and distribution of investigation product. Mentor junior colleagues in the CTM team as required.
Primary Responsibilities:
- Review and Interpretation of a clinical protocol or study overview:
- Review and provide feedback during the development of the clinical protocol.
- Calculate total demand and translation of total demand into a demand forecast.
- Interface with Project Managers to develop clinical supply timelines, obtain study overviews and drug requirements, and initiate procurement procedures.
- Periodically reviews and updates inventories including all supply related information such as lot numbers, current status, and kit genealogy and expiration date extension.
- Tracks expired materials and issues orders for retrieval or disposal.
- Be proficient with current inventory and tracking systems by learning their usage, updates and maintenance.
- Proposes and implements improvements to assure efficient clinical supply operations.
- Investigates and resolves issues regarding inventory, shipments and returns.
- Responsible for end to end, full CTM lifecycle, ensures that all clinical trials have timely and an un-interrupted supply of CTM.
- Coordinates CTM activities with Clinical Supply Packagers and Distributors, Technical Services, Clinical R&D staff, Project Teams, IT/IS, Data Management, CROs and other sites and departments as necessary
- Develops and maintains CTM documentation necessary to support company policies, procedures and all regulatory guidelines
- Works with Clinical, Regulatory and Quality teams in preparing label text, obtaining translations and approval of label proofs
- Prepares and reviews applicable contracts, project statements, change orders, packaging requests, and batch records for accuracy and completeness
- Reconciles and approves invoices
- Prepares reports to ensure accuracy and completeness of clinical supplies information. Maintains departmental reports and files, updates SOPs and other projects as assigned
Education/Experience/Skills
- Minimum Bachelor of Science degree (BS) in Health Science (preferred Master of Science degree). Equivalent combination of relevant education and applicable job experience may be considered with at least 4-6 years' experience in pharmaceutical development focused on clinical trial materials
- The individual must be well versed in GXPs (GMP, GCP, and GDP) and as well as other regulatory requirements as they pertain to investigational products
- Proven project management skills
- Ability to handle multiple projects simultaneously
- Good understanding of GMP working environments and regulatory guidance and regulations (e.g. ICH, 21 CFR Part 11)
- Good understanding of IRT system build-up and user testing
- Good negotiating skills with customers and suppliers
- Hands on training and experience in clinical trial methodology and Good Clinical Practice
- Good organizational and documentation skills
- Demonstrated track record of ability to self-direct and resolve issues with the vendors, CRO staff and internal teams
- Excellent written and verbal communication skills
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization
- Skilled at creating a cooperative team environment
- Able to objectively evaluate situations and make recommendations for changes in light of overall project demands
Physical Requirements:
This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.
#LI-HYBRID #NC1
What we offer US-based Employees:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
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Clinical Trial Manager
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Who we are:
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
How we work:
- PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
- COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
- BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you’ll make an impact:
- Contribute to the planning, implementation and execution of a global clinical trial
- Responsible for management of vendors to support clinical trial execution
- Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed
- Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
- Manage study timelines and metrics to ensure completion of study deliverables
- Support site selection, qualification, initiation, and monitoring activities.
- Review monitoring reports to ensure quality and resolution of site-related issues.
- Ensure timely enrollment and data collection at clinical trial sites.
- Collaborate with the data management team to ensure data integrity and timely database lock.
- Review and analyze clinical trial data to identify trends and potential issues.
- Ensure tracking and review of protocol deviations and assess impact on study data
- Develop relationships with investigators and site staff
- Work closely with CRO and Medical Monitor to ensure safety and efficacy data appropriately summarized to facilitate review.
- Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
- Maintain accurate and complete trial documentation.
- Proactively identify and resolve clinical project issues
Skills and experience you’ll bring:
- Bachelor of Science in Life Sciences and 3+ years (CTM)/5+ years (Sr. CTM) as a project/clinical trial manager in biotech/pharmaceutical industry.
- Experience working on large, global, complex Phase 2 clinical trial(s).
- Broad knowledge of regulatory and ICH GCP guidelines, HIPAA, Protection of Human Research Subjects.
- Strong project management skills with the ability to manage multiple trials simultaneously.
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in a fast-paced, dynamic environment with cross-functional teams.
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
- Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
- The anticipated base salary range for this role is $115,000 – $200,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
- Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.
Ready to apply?
Apply to Kymera Therapeutics
Associate Director or Director, Clinical Operations
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Who we are:
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
How we work:
- PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
- COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
- BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you’ll make an impact:
- Contribute to the planning, implementation, and execution of global clinical trials.
- Plan, execute, and lead study-specific meetings (e.g., internal core team meetings, investigator meetings, etc), as needed.
- Provide input for the design of the Informed Consent Form(s), eCRFs, monitoring conventions, edit checks, etc.
- Provide study-specific training and leadership to clinical research staff, CRO, CRAs, sites and other contract personnel.
- Manage study timelines and metrics to ensure completion of study deliverables.
- Lead site feasibility and selection qualification, initiation, and oversight of outsourced monitoring activities.
- Review monitoring reports to ensure quality and resolution of site-related issues.
- Ensure timely enrollment and data collection at clinical trial sites.
- Collaborate with the data management team to ensure data integrity and timely database lock.
- Ensure tracking, review of protocol deviations, and assess impact on study data.
- Work closely with translational medicine team to ensure appropriate incorporation of bioanalytical sampling plan into clinical protocols and relevant data output of the trial is provided to functional groups for review.
- Partner with Operational Excellence and assigned Site Engagement Leads to help drive site engagement and bolster recruitment
- Serve as key counterpart of Clinical Outsourcing to build RFPs and support the selection of clinical vendors
- Oversee and contribute to Sponsor Oversight activities including but not limited to review of KPIs, KRIs, PDs, risks, Data Review Findings, etc. to assess the health of the study and proactively ensure mitigations are in place to achieve Kymera’s quality standards
- Contribute to clinical operations process improvement initiatives
- Maintain accurate and complete trial documentation.
- Proactively identify and resolve clinical project issues.
- This role may require up to 25% travel
Skills and experience you’ll bring:
- BS degree and 8+ years of experience in clinical operations in biotech/pharma. 5 years’ experience leading global clinical trials
- Inspection readiness experience preferred
- Experience working on large, global, complex phase 2b/3 or late stage trials. Respiratory or Immunology experience highly preferred.
- Broad knowledge of Global regulations and guidelines including CFR, ICH GCP, HIPAA, GDPR, and the Protection of Human Research Subjects.
- Strong project management skills with the ability to manage multiple trials simultaneously.
- Excellent problem-solving, leadership, and communication skills.
- Ability to work in a fast-paced, dynamic environment with cross-functional teams.
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
- Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
- The anticipated base salary range for this role is $160,000 – $275,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
- Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.
Ready to apply?
Apply to Kymera Therapeutics
Senior Director, Clinical Operations
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Who we are:
Kymera is a clinical-stage biotechnology company pioneering the field of targeted protein degradation (TPD) to develop medicines that address critical health problems and have the potential to dramatically improve patients’ lives. Kymera is deploying TPD to address disease targets and pathways inaccessible with conventional therapeutics. Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. Founded in 2016, Kymera has been recognized as one of Boston’s top workplaces for the past several years. For more information about our science, pipeline and people, please visit www.kymeratx.com or follow us on X (formerly Twitter) or LinkedIn.
How we work:
- PIONEER: We are courageous, resilient and rigorous in our mission to improve patients’ lives through our revolutionary degrader medicines.
- COLLABORATE: We value trust + transparency from everyone. Our goals are shared, our decisions data-driven and our camaraderie genuine.
- BELONG: We recognize our differences, inviting curiosity and inclusivity, so that our people are valued, seen, and heard.
How you’ll make an impact:
The Senior Director, Clinical Operations is a leadership role responsible for overseeing and managing all aspects of clinical operations for the Phase 3 program of a high priority immunology program, KT-621. This individual will be accountable for driving the cross-functional strategy and rigorous operational execution through regulatory approval. This person possesses clinical operations expertise with a track record of success, working with peers and stakeholders. The Senior Director will be a leader in the organization who knows how to hire and manage a team internally, at our clinical sites, and with our vendors.
- Lead and oversee the strategic planning, implementation and execution of late stage clinical trials across a key immunology program in accordance with project timelines, budget, and quality standards (including ICH GCP and local regulations)
- Develop and manage comprehensive program project plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies
- Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs, Biostatistics and Program Leadership to ensure alignment on clinical trial objectives and milestones
- Provide operational expertise and strategic input into the development of Clinical Development Plans (CDP), supporting the overall clinical strategy for the program
- Accountable for robust operational strategies for all studies in the Phase 3 program, ensuring consistency as needed, including country and site mix, PR&R and Site Engagement strategies, vendor strategy, risk based and site monitoring strategies, etc
- Serve as the point of contact for CROs and vendors, overseeing their performance and ensuring adherence to contractual agreements, timelines and quality standards
- Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct
- Accountable for inspection readiness and provides appropriate guidance to Clinical Study Leads in support of inspection activities
- Contribute to the preparation and review of clinical study documents including the Investigator Brochure, Investigational New Drug Applications (IND), study protocols, clinical study reports, applicable sections of New Drug Applications (NDA) and or Marketing Authorization Application (MAA), updates to the IND, NDA and other safety reports
- Hire, train and develop the Clinical Operations KT-621Phase 3 team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence
Skills and experience you’ll bring:
- BA/BS, preferably in a health-related field
- 12+ years of experience in clinical operations within the pharmaceutical or biotechnology industry
- Prior experience building and leading a high-performing clinical operations team
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to, US CRF, EU CTD and ICH GCP
- Ability to manage multiple competing priorities and adapt to changes in a high-pressure environment
- Strong communication, interpersonal, and problem solving skills
- Must be comfortable working in a fast-paced environment
Kymera Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.
Compensation
- Kymera offers a competitive compensation package that recognizes both results and capabilities through market-based, performance-driven pay.
- The anticipated base salary range for this role is $235,000 - $330,000, with eligibility for annual bonus, equity participation, and comprehensive benefits.
- Actual salary is based on a holistic evaluation of the specific role/level as well as each candidate’s depth of experience and the capabilities they bring to the position.
Ready to apply?
Apply to Kymera Therapeutics
Clinical Vendor Acquisition Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
Reporting to the Director of Study Feasibility & Clinical Partnerships, the Clinical Vendor Acquisition Manager plays a critical role in identification, sourcing, qualification, onboarding, negotiation, and management of vendor relationships to support Care Access objectives. This role, in collaboration with Feasibility, SSU, Finance, and Operations ensures cost-effective procurement, strong contractual protection, compliance, and high-performing clinical vendor partnerships.
How You'll Make An Impact
- Clinical protocol review and vendor requirements identification
- Review clinical protocols and other study documents to determine vendor scope and compatibility; translate protocol elements into vendor qualifications and study requirements
- Clinical vendor acquisition
- Identify potential vendors based on the requirements of the protocol and other sponsor-provided study documents
- Conduct market research to assess vendor capabilities, pricing models, and risk factors
- Develop and maintain a preferred vendor network
- Lead RFPs, RFQs, and vendor selection processes
- Contracting & negotiation
- Draft, review, negotiate, and finalize vendor contracts in collaboration with direct report, legal and finance teams.
- Track contract renewals, expirations, amendments, and compliance requirements.
- Vendor Management
- Identify and troubleshoot vendor-related issues impacting clinical execution or study timelines; act as clinical escalation point for vendor readiness concerns
- Establish performance metrics and monitor vendor performance against SLAs and KPIs.
- Resolve service, performance, and billing issues in a timely manner.
- Drive continuous improvement and cost optimization initiatives
- Maintain vendor documentation and compliance records
- Serve as the clinical point-of-contact for vendors, ensuring timely responses when study manuals are unavailable.
- Standardize and improve communication pathways between vendors, SSU teams, and internal stakeholders.
- Develop and refine vendor management processes to optimize efficiency and quality.
- Guide internal and external stakeholders on vendor requirements, protocol expectations, training, and procedures.
- Participate in governance calls and internal meetings to provide updates on vendor performance and risk status.
- Develop tools, templates, and training materials to strengthen vendor onboarding and oversight processes.
- Maintain internal database in Sharepoint as well as SalesForce
- Review study information and use internal databases, trackers, and dashboards as resources Other duties as assigned
The Expertise Required
- Strong understanding of clinical protocols, trial execution, and start-up workflows.
- Prior vendor experience with the ability to discuss protocol clinical aspects with vendors.
- Skilled at guiding vendor partners and internal teams on protocol expectations, training, and procedures.
- Effective communicator of vendor requirements both internally and externally.
- Experience working with site networks; direct site-based experience strongly valued.
- Ability to negotiate and 'sell' Care Access’s value to vendor partners
- Experience interacting with investigators, clinical staff, and site teams to support operational decision-making.
- Strong cross-functional communication skills in a fast-paced, matrixed environment.
- Creative, outside-the-box problem solving with openness to brainstorming solutions.
- Proactive mindset with ownership, accountability, and focus on clinical quality.
- Ability to foresee risks based on historical knowledge, manage escalations efficiently, and follow up across governance structures.
- Data management skills for tracking KPIs, vendor performance, and escalation logs.
- Ability to hold vendors accountable to agreed timelines and deliverables.
- Capacity to effectively document historical vendor performance and leverage it for future pipeline planning.
- Experience creating and implementing new processes based on role and company needs.
- Experience reviewing, interpreting, and providing feedback on vendor contracts, including identifying risks, obligations, and compliance requirements.
- Proven ability to manage the full lifecycle of vendor contracts, from negotiation through execution, renewal, and termination.
Certifications/Licenses, Education, and Experience
- Bachelor’s degree in life sciences, healthcare, nursing, or related field (advanced degree preferred).
- 3–5 years of experience in clinical operations, vendor management, or clinical trial start-up.
- Prior vendor-facing experience within clinical trials required.
- Familiarity with vendor acquisition and management, and contracting workflows.
- Experience in Clinical Project Management is strongly preferred.
- Proficiency with CTMS, clinical portals, and project tracking tools.
How We Work Together
- Travel: This is a remote position with up to 50% travel requirements.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $80,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
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Research Associate
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Research Associate, Patient-Centered Outcomes
Who we are: Adelphi Values is a leading health outcomes consultancy that works with a wide range of pharmaceutical companies. The Patient-Centered Outcomes (PCO) team are global leaders in the selection, development, validation, and use of Patient-Reported Outcome measures (PROs) and other Clinical Outcome Assessments (COA). We are a dedicated team of researchers proud of our friendly, supportive culture, reputation for high-quality research, and client service which puts the patient at the centre of drug development.
What we do: Our purpose is to improve patients’ lives by informing healthcare decisions. We do this by supporting clients in the selection, development, psychometric validation, and implementation of COAs that form clinical trial endpoints or are used in clinical practice to support the evaluation of the patient experience and assessment of treatment benefit.
What we are looking for: A highly motivated entry-level Research Associate with a passion for applying and enhancing their healthcare research skills in a challenging and rapid-moving field. You will have an undergraduate/postgraduate degree (BSc, MSc, or similar) in health psychology, psychology, psychological research methods, sociology, or life sciences. Work experience in a related research or health setting is desirable but not essential. You should ideally have knowledge and experience of literature review methodology, qualitative/quantitative analysis, and research design including data collection, analysis, interpretation, and dissemination. Experience of questionnaire development is desirable but not essential. Fluency in Microsoft Office packages, organisational skills, self-motivation, and attention to detail is essential, along with a teamwork ethos and an appetite for working in a fast-paced, fun environment. You must have eligibility to work in the UK.
How you fit in: You will join a dynamic team of researchers with a passion for excellence in research and client service. You will have a genuine interest in understanding, evaluating, and communicating the patient perspective. You will have the opportunity to learn about many different health conditions and develop your skills in qualitative, quantitative, and mixed methods research.
You will be involved in studies focused on the selection, development, psychometric validation of COAs. You will be involved in a range of research activities including conducting literature reviews, developing study protocols and statistical analysis plans, preparing study documentation for ethical review, the recruitment and interviewing of study participants, data analysis, the reporting of study findings, and writing conference abstracts/posters, and journal manuscripts. You will be involved in multiple projects at any one time so good communication and organisational skills are essential.
What we offer: Our benefits package includes a competitive salary, performance-related rewards, health insurance, pension, and on-site gym membership. We provide support for training and development along with career progression opportunities. This position is based at our head office in the pretty village of Bollington, near Macclesfield. This position is a hybrid role of office and home based working, with ~2 days minimum expected in the office. Therefore, it would be preferable for you to be within commuting distance of Bollington.
If you are looking to work in a professional, challenging, and rewarding environment click ‘apply’, and apply directly via our website.
Recruiters
Applications from recruitment agencies will not be accepted.
Omnicom Health is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we’re focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you. We will process your personal data in accordance with our Recruitment Privacy Notice.
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Associate Director, External Communications
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Who We Are:
Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.
Position Description:
We are seeking an experienced Associate Director, External Communications to join our Corporate Communications team. In this key role, you will develop and execute communication plans that increase awareness of Calico’s scientific advancements, clinical milestones, and partnerships.
Reporting to the Senior Director of Corporate Communications, you will play a key role in maintaining a cohesive brand narrative that reinforces Calico’s overarching mission and translating scientific excellence into compelling external presence as we advance our lead programs toward potential commercialization and patient impact. In addition to subject matter expertise, this position will require strong collaboration and project management skills as you will work with a cross-functional team to shape how our development programs are perceived by the global scientific and medical communities, patients, advocacy groups, media, and our employees.
Responsibilities:
- Drive communication strategies that develop scientific and medical thought leadership, positioning Calico and its leaders as credible voices through publications, congress presence, executive visibility, and media engagement
- Develop compelling, consistent, and effective messaging for corporate communications materials such as press releases, media materials, Q&A, slide decks, talking points, website content, social media, and videos
- Partner with cross-functional team members to drive disease awareness and patient advocacy communications across our clinical programs, particularly our current lead indications
- Effectively collaborate with cross-functional teams, external partners, and agencies to ensure high quality and compliant communications that drive clinical trial recruitment and brand awareness across our clinical portfolio
- Serve as a frontline responder for external/media inquiries and manage communications surrounding clinical data readouts, regulatory milestones, and patient/caregiver inquiries
- Work with partners to develop and execute deal communications
- Provide ad-hoc support across internal communications as needed
- Proactively seek out opportunities to maximize the impact of Corporate Communications
Position Requirements:
- Bachelor’s degree in Communications, Journalism, or life sciences field is required, advanced degree a plus
- 10+ years of experience in public relations or communications within the biotech or pharmaceutical industry, including product communications (rare disease experience a plus)
- Direct experience managing pre-launch communications for a breakthrough or orphan drug therapy is highly preferred
- Strong scientific understanding of a how a molecule moves through the discovery and development lifecycle
- Exceptional verbal and written communication skills with a proven track record of translating complex science for diverse audiences
- Expert at managing multiple high-stakes projects simultaneously without compromising accuracy or quality
- Ability to bridge high-level strategic planning with meticulous tactical execution
- Demonstrated agency and urgency in driving projects forward while remaining thoughtful and inclusive of cross-functional partners
- Confidence to influence and align senior stakeholders to support communication objectives
- Must be willing to work onsite at least four days a week
The estimated base salary range for this role is $195,000 - $200,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.
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Director, Compliance
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Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
Position Overview
We are seeking a detail-oriented Director, Compliance to join Iterative Health's growing team in New York, NY or Cambridge, MA. This role will be instrumental in leading the strategic development of compliance programs to ensure our clinical trial optimization solutions meet all regulatory requirements across healthcare, clinical trials, and data privacy domains. The ideal candidate will have deep expertise in healthcare compliance frameworks and the ability to operationalize complex regulatory requirements in a fast-paced health tech environment.
Key Responsibilities
Regulatory Compliance & Risk Management
- Experienced with the compliance aspects of clinical trial & clinical research
- Maintain comprehensive compliance with GDPR, HIPAA, and other applicable data privacy regulations
- Lead SOC 2 Type II audit preparation and ongoing compliance, including controls documentation and evidence collection
- Develop and implement compliance policies and procedures specific to clinical trial technologies and healthcare AI solutions
- Ensure adherence to Anti-Kickback Statute, Stark Law, and PhRMA Code requirements in all business relationships
- Monitor evolving AI regulations and their impact on clinical trial optimization platforms
Quality Management & Documentation
- Oversee Quality Management System (QMS) in partnership with other team members, for maintenance and contractual compliance
- Establish and maintain comprehensive record retention policies across clinical, regulatory, and business functions
- Manage document control processes for clinical protocols, compliance documentation, and regulatory correspondence
- Coordinate with clinical operations team to ensure GCP compliance in trial management and data collection
Contract & Vendor Compliance
- Review and negotiate compliance terms in customer agreements, vendor contracts, and clinical trial agreements
- Conduct vendor risk assessments and ongoing compliance monitoring for third-party service providers
- Ensure contract compliance with healthcare customer requirements, including BAAs and data processing agreements
- Support commercial team with compliance aspects of customer onboarding and due diligence processes
Training & Cross-Functional Support
- Develop and deliver compliance training programs for employees across all functions
- Serve as primary compliance liaison with external auditors, regulators, and certification bodies
- Collaborate with legal, clinical, and product teams on regulatory strategy and risk mitigation
- Maintain compliance calendar and ensure timely completion of regulatory filings and renewals
Required Qualifications
Education & Experience
- Bachelor’s degree in Life Sciences, Business, or a related field plus 8+ years of compliance experience in healthcare, biotech, or clinical research organizations; advanced degree preferred
- OR Juris Doctor (JD) or other advanced degree plus 5+ years of compliance experience in healthcare, biotech, or clinical research organizations
- Direct experience with clinical trial regulations and GCP requirements
- Proven track record managing compliance programs in regulated industries
Technical Expertise
- Employment law and HR compliance expertise, including workplace privacy, salary transparency, employee data protection, and regulatory training requirements
- Corporate governance and general business compliance including anti-corruption, export controls, and corporate record-keeping requirements
- Privacy program management across all business functions, including vendor privacy assessments and cross-border data transfer compliance
- Financial compliance awareness including regulatory reporting requirements
- Deep knowledge of GDPR and HIPAA requirements and implementation
- Hands-on experience with SOC 2 audits and information security compliance frameworks
- Familiarity with clinical research regulations (GCP, ICH guidelines, 21 CFR Part 11)
- Understanding of AI/ML regulatory landscape in healthcare and clinical trials
Core Competencies
- Strong analytical and problem-solving skills with ability to translate complex regulations into actionable policies
- Excellent written and verbal communication skills for regulatory correspondence and training delivery
- Project management experience with ability to manage multiple compliance initiatives simultaneously
- Detail-oriented approach with strong documentation and process improvement capabilities
Preferred Qualifications
- Professional certifications (CIPP, CISA, CCEP, CHRC, or similar compliance credentials)
- Experience with international regulations (EU Clinical Trials Regulation, other global markets)
- Background in clinical research or pharmaceutical compliance
- Familiarity with AI ethics and algorithmic bias considerations in healthcare
- Experience with healthcare technology or SaaS compliance programs
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
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Regional Director, Sites
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Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need.
About the Role
The Regional Director is responsible for owning and optimizing site-level performance across a portfolio of GI-focused clinical research sites. This role ensures operational excellence by aligning teams around key performance goals, elevating site capabilities, and maintaining consistency in trial execution. As a strategic operations leader, the Regional Director plays a central role in connecting site level performance with broader business objectives.
Responsibilities
- Manages staff across multiple sites, ensuring execution is aligned with protocol, regulatory requirements, and IH standards.
- Owns overall performance of assigned sites, including enrollment, data quality, compliance, and team culture.
- Ensures sites are set up for success (i.e. staffed appropriately and equipped with the appropriate equipment and training) and makes recommendations to allocate resources based on business needs.
- Builds strong relationships and collaborates with PIs to align their engagement with study goals and operational strategy.
- Influences study portfolio, optimizing for profitability and value to patients.
- Identifies and manages issues, concerns and problems related to site performance.
- Leads and develops CRCs, and other site-based research staff through clear expectations, performance coaching, and team development.
- Serves as a visible, hands-on people manager who builds high-performing, accountable teams.
- Identifies levers to drive site level KPIs through monitoring KPIs and performance trends, escalating to appropriate parties.
- Implements corrective actions or process improvements as needed.
- Serves as the primary operational liaison between site staff and central functions.
- Drives a culture of ownership, collaboration, and continuous improvement across all assigned sites.
What We’re Looking For
Required Qualifications
- Knowledgeable about the critical elements for success in clinical trials: Ability to review protocols, programs, and assess the success of a project.
- Ability to influence change management and model flexibility
- Problem-Solving Skills: Ability to identify problems, develop and implement solutions.
- Strategic Planning: Ability to plan for short, medium and long term success and make recommendations for growth
- Ability to use data as a tool, identify trends, and draw conclusions.
- Project Management: Demonstrated ability to successfully manage people/projects.
- Proactive problem-solving abilities and follow-through.
- Practices professionalism and integrity in all actions.
- Communication Skills: Excellent written and verbal communication skills.
- Working knowledge of CTMS, eDC and other core research systems.
- Ability to travel: Up to 30% travel to provide operational oversight, hold team meetings, and attend other professional meetings/conferences as needed.
Preferred Qualifications
- Experience in managing a large site network and demonstrated success in achieving targets and optimizing operations.
- Experience with gastroenterology and/or hepatology studies.
What We Offer
- Medical, dental, and vision insurance
- Life and disability insurance
- Parental leave
- Stock options
- Flexible work hours
- Unlimited paid time off
At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.
Ready to apply?
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General Manager, Clinical Trials and Site Management
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Location: Brentwood, TN. (Onsite Preferred; Remote Considered)
IVX Health is a national leader in high‑quality infusion and injection therapy, operating 150+ ambulatory centers across the U.S. Backed by Linden Capital Partners, we continue to scale rapidly—expanding services, accelerating growth, and building the leading ambulatory infusion platform in the country.
We are launching a clinical trials platform across our national footprint and seeking a senior operator to build, lead, and scale this new business.
About the Role
The General Manager, Clinical Trials & Site Management will design and run IVX Health’s clinical trials operating model - from start-up through national expansion. This leader will ensure compliant, inspection‑ready performance across all sites, serve as the external-facing executive for sponsors and CROs, and ultimately own the P&L for the clinical trials service line.
What You’ll Do
- Build and operationalize a scalable clinical trial site management model leveraging IVX Health’s clinical and operational infrastructure.
- Lead execution of clinical trials across multiple sites, ensuring protocol adherence, predictable study start‑up, and high‑quality administration and documentation.
- Serve as the senior accountable leader for regulatory compliance, quality, SOP governance, training, documentation integrity, and CAPA.
- Partner with Clinical, Operations, Legal, Finance, and Regional teams to integrate research into daily clinical workflows.
- Represent IVX Health as an operational subject matter expert in sponsor and CRO discussions, supporting feasibility, execution, and compliance credibility.
- Build and lead a centralized trials team to support scale and standardization.
- Assume increasing financial accountability, evolving to full P&L ownership and long‑term strategic planning.
What You Bring
Required
- 10+ years of senior experience in clinical trial site management, SMO leadership, or research operations within an academic medical center.
- Direct, hands-on leadership of clinical trial sites and active studies from start‑up through close‑out.
- Deep expertise in FDA regulations, ICH GCP, IRB requirements, inspections, audits, and CAPA management.
- Proven ability to lead cross‑functional teams and serve as a credible executive with sponsors and CROs.
Preferred
- Experience executing or scaling multi‑site clinical trials.
- Exposure to P&L ownership or financial accountability (formal GM title not required).
- Background in infusion-based or procedure-intensive trials.
- Experience scaling operations while maintaining high regulatory and quality standards.
About IVX Health
IVX Health is a national provider of infusion and injection therapy for individuals managing chronic conditions like Rheumatoid Arthritis, Crohn's Disease, and Multiple Sclerosis. We’re transforming the way care is delivered with a focus on patient comfort and convenience. Our commitment to exceptional care extends to our employees as well—we empower our team to thrive while living our core values: Be Kind, Do What’s Right, Never Settle, Make It Happen, and Enjoy the Ride.
Our Mission: To improve the lives of those we care for by redefining the care experience
Our Vision: To be the nation’s preferred destination for pharmaceutical care of complex chronic conditions
Our Commitment: To deliver an unmatched care experience with a foundation in world class service and clinical excellence
Benefits We Offer
- Comprehensive Healthcare – Medical, dental, and vision coverage, including prescription drug plans and telemedicine services.
- Flexible Savings Options – Choose from Health Savings Accounts (HSA) and Health Reimbursement Arrangements (HRA) to manage healthcare costs.
- Supplemental Protection – Accident, critical illness, and hospital indemnity plans to provide additional financial security.
- Dependent Care FSA – Pre-tax savings for eligible childcare and dependent care expenses.
- 401(k) Retirement Plan – Secure your future with a competitive company match.
- Disability Coverage – Voluntary short-term and long-term disability plans to protect your income.
- Fertility and Family Support – Resources and benefits designed to support fertility care and family planning.
- Life and AD&D Insurance – Financial protection for you and your loved ones.
- Counseling and Wellness Support – Free resources to support emotional, physical, and financial well-being.
- Education Assistance – Tuition reimbursement and certification support to help you grow in your career.
- Continuing Education – Access to a CEU library for ongoing professional development.
- Charitable Giving and Volunteer Program – Matched donations and paid volunteer time off to support causes you care about.
- Employee Referral Bonus – Earn rewards for helping us find top talent.
Note: Benefits may vary by employment type. Contact HR for details on eligibility and coverage.
EEO STATEMENT
IVX Health is proud to be an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees. IVX Health wants to have the best available people in every job, and we make employment decisions on the basis of business needs, job requirements, individual qualifications, and merit. Equal employment opportunities are provided to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, military and veteran status, age, physical or mental disability, genetic characteristic, reproductive health decisions, family or parental status, or any other legally protected category in accordance with applicable federal, state, or local laws. IVX Health prohibits discrimination, harassment, or retaliation of any kind based on any of these characteristics. Equal employment opportunity will be extended to all persons in all aspects of the employer-employee relationship and all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation benefits, and separation of employment.
Privacy Policy
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Project Manager, Medical Affairs
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At Adaptive, we’re Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.
As an Adapter, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application.
It’s time for your next chapter. Discover your story with Adaptive.
Position Overview
The Project Manager, Medical Affairs at Adaptive Biotechnologies plays a central role to support product development and commercialization through Medical Affairs-led initiatives, reporting to the Director of Medical Affairs. We are looking for a strategic and results-driven individual who thrives in a fast-paced, collaborative environment. The successful candidate will work cross-functionally to lead and support key projects and initiatives. Projects, including Adaptive-sponsored and Investigator-sponsored research studies, are expected to be scoped comprehensively, completed on time, on budget, to meet the desired goals of the business, with an emphasis on data generation. The role will work independently to plan, direct, track, and coordinate research activities from inception to operationalization.
Key Responsibilities and Essential Functions
- Project Lifecycle Management
- Lead internal research projects from initiation through completion, including scope definition, planning, execution, and documentation.
- Track external collaborative research projects to develop and maintain study workflows, assess progress, proactively manage risks, and support timely data availability for analysis, publication and presentation at key congresses.
- Ensure alignment on project goals, rationale, and roles & responsibilities with stakeholders and leadership.
- Develop and maintain project charters, timelines and work plans, driving accountability across the team.
- Facilitate clear communication across project teams, internal partners, functional leaders, and external collaborators.
- Identify and manage risks and issues, proactively communicating and adjusting plans as needed.
- Partner with other Program and Project Managers across Adaptive to support infrastructure for project management, prioritization, communication, and institutional knowledge sharing.
- Participate in cross-functional initiatives as a contributing team member.
- Analysis, Metrics & Reporting
- Perform / support analysis to inform business case and resource allocation
- Define metrics for project success and determine how to measure
- Provide regular reporting on project status to manager and project team, highlighting key risks, issues, and milestones.
- Strategic Planning for Clinical Study Data Generation
- Contribute to the development and execution of research studies that support MRD product and commercial strategy
- Clinical study execution support: Track protocol development, contracting, study start-up, and coordinate cross-functional operational workflows (Regulatory/IRB, Clinical Trials, lab teams).
- IRB protocol coordination: Facilitate IRB protocol submissions and related materials; track IRB protocol progress, approvals, and renewal dates; and coordinate record updates and amendments as required to ensure protocols do not lapse and study activities remain appropriately covered.
- Visibility + stakeholder communication: Provide clear status reporting, surface critical-path risks, and align on mitigation/alternative plans with Medical Affairs leadership and key stakeholders.
- Scientific output enablement: Track data generation and publication/congress timelines, maintain data-readiness visibility, and build/maintain tracking tools and outreach tracking for study opportunities/sites.
- All other duties as assigned
Position Requirements (Education, Experience, Other)
Required
- Bachelor’s Degree and 5+ years (or Master’s Degree and 3+ years) of Project Management experience with 2+ years' experience in a biomedical research, biotech, or healthcare setting
- Project Management Professional (PMP) or equivalent certification
- Demonstrated understanding of Project Management processes, strategies and methods
- Familiarity with clinical trial operations
- Proven track record of successful project and/or operational delivery in a biomedical research, biotech or healthcare setting.
- Demonstrated ability to succeed in a deadline-driven environment, solve problems, and prioritize tasks.
- Expertise with the project management life cycle (initiating, planning, executing, monitoring, closing) and change management.
- Expertise with tools that facilitate project management, such as Smartsheet, LucidChart, MS Office suite (Teams, Word, Excel, PowerPoint) and SharePoint.
- Excellent communication skills (oral, written, presenting) with the ability to build relationships across all levels of the organization.
- Self-motivated and works independently, with minimal supervision.
- Strong experience facilitating project team meetings, cross-functional communication and decision-making ensuring alignment with internal and potentially external stakeholders in a highly matrixed organization
Preferred
- Familiarity with regulatory and reimbursement pathways for diagnostic products (e.g., FDA, CLIA, CE-IVD).
- Familiarity with the real-world data/evidence lifecycle, data governance, processes, and operating models.
- Experience from at least two successful commercial product launches in diagnostics.
- Experience working with R&D, clinical, regulatory, marketing, and commercial teams to bring products from concept to market.
- Experience performing business opportunity assessments.
#LI-Remote
Compensation
Salary Range: $101,600 - $152,400
Possible “other compensation” elements to include:
- equity grant
- bonus eligible
ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers, provide fake documents, and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket, including home office supplies and equipment.
Interested in this position, but don’t meet all the requirements? Adaptive is committed to building diverse, equitable, and inclusive teams across our organization. Please consider applying even if your experience doesn’t match all the qualifications; you may be the exact candidate we’re searching for!
Adaptive is not currently sponsoring candidates requiring work authorization support for this position.
Adaptive’s posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process, including: a candidate’s ability to meet minimum qualifications (skills/experience/education), a candidate’s ability to thoughtfully address preferred qualifications, current market conditions, and internal pay equity. Listed base salary is exclusive of bonus, commission, equity, differential pay, benefits, and other incentives.
Adaptive's benefits at-a-glance.
Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability. Please refer the “Know Your Rights: Workplace Discrimination is Illegal” Poster for more information. If you’d like to view a copy of the company’s affirmative action plan or policy statement, please email hr@adaptivebiotech.com.
If you have a disability and you believe you need a reasonable accommodation to search for a job opening or to submit an online application, please e-mail accommodations@adaptivebiotech.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.
NOTE TO EMPLOYMENT AGENCIES: Adaptive Biotechnologies values our relationships with our Recruitment Partners and will only accept resumes from those partners who have active agreements with Adaptive. Adaptive Biotechnologies is not responsible for any fees related to resumes that are unsolicited or are received by any employee of Adaptive Biotechnologies who is not a member of the Human Resources team.
Ready to apply?
Apply to Adaptive Biotechnologies
Site Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Site Manager is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials.
How You'll Make An Impact
- Management of Studies and Site Workload:
- Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
- Coordinate Investigator and Sub-Investigator coverage
- Work with Region Manager to identify outside vendors needed for studies
- Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
- Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
- Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
- Update Region Manager on all pending and active study details
- Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
- Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
- Attend all study audits and play an active role in their management and execution of follow up items
- Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
- Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
- Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
- Personnel:
- Review and approve PTO requests, ensuring there is adequate coverage at the site
- Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
- Participate in the interview process for site staff
- Ensure site staff complete all required training
- Encourage a positive team-oriented environment
- Work with Region Manager to ensure high staff morale and low turnover rates
- Report all personnel issues to Region Manager
- Conduct weekly one on ones with staff and maintain appropriate documentation
- Lead by example and display a high level of integrity and professionalism.
- Financial:
- Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
- Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
- Work with Region Manager to identify and communicate staff needs
- Ensure there are adequate supplies and equipment on site
- Site Maintenance:
- Keep Region Manager apprised of any site maintenance issues
- Coordinate building and equipment maintenance
- Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives
- Ensure staff are following guidelines and SOP’s as pertain to the sites
- Ensure that site have the equipment necessary to safely perform job responsibilities
- Work with the Region Manager to review and address injury reports if necessary
- Ensure the lab follows IATA guidelines and applicable staff are properly certified
- Collaborate and communicate with other departments regarding inter-site issues
- Keep Region Manager apprised of any site maintenance issues
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
The Expertise Required
- Strong organizational and planning skills to maintain a busy and diverse work schedule
- Proactive approach with the ability to work autonomously
- Excellent problem-solving skills
- The ability to multi-task and work well within a high-paced pressurized environment
- The ability to use your initiative to deliver a great customer experience
- Excellent communication skills paired with the ability to develop and nurture relationships
- Intermediate/Advanced IT skills including experience of using Word, Excel, Outlook and PowerPoint
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Ability to communicate and work effectively with a diverse team of professionals
- Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
- Critical thinker and problem solver
- Excellent interpersonal skills, detail-oriented and meticulous
- Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
- High level of self-motivation and energy
- Excellent professional writing and communication skills
- Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals
- Ability to work evenings and weekends as needed
- Must have access to reliable transportation
Certifications/Licenses, Education, and Experience
- Bachelor’s Degree or equivalent professional experience
- Research Professional Certification
- A minimum of 5 years of clinical research experience
- A minimum of 3 years prior Clinical Research Coordinator experience
- Previous Research Site Management experience preferred
- Spanish fluency preferred
How We Work Together
- Location: This is an on-site position with regional commute requirements.
- Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (<10%).
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $80,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
Site Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Site Manager is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials.
How You'll Make An Impact
- Management of Studies and Site Workload:
- Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
- Coordinate Investigator and Sub-Investigator coverage
- Work with Region Manager to identify outside vendors needed for studies
- Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
- Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
- Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
- Update Region Manager on all pending and active study details
- Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
- Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
- Attend all study audits and play an active role in their management and execution of follow up items
- Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
- Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
- Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
- Personnel:
- Review and approve PTO requests, ensuring there is adequate coverage at the site
- Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
- Participate in the interview process for site staff
- Ensure site staff complete all required training
- Encourage a positive team-oriented environment
- Work with Region Manager to ensure high staff morale and low turnover rates
- Report all personnel issues to Region Manager
- Conduct weekly one on ones with staff and maintain appropriate documentation
- Lead by example and display a high level of integrity and professionalism.
- Financial:
- Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
- Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
- Work with Region Manager to identify and communicate staff needs
- Ensure there are adequate supplies and equipment on site
- Site Maintenance:
- Keep Region Manager apprised of any site maintenance issues
- Coordinate building and equipment maintenance
- Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives
- Ensure staff are following guidelines and SOP’s as pertain to the sites
- Ensure that site have the equipment necessary to safely perform job responsibilities
- Work with the Region Manager to review and address injury reports if necessary
- Ensure the lab follows IATA guidelines and applicable staff are properly certified
- Collaborate and communicate with other departments regarding inter-site issues
- Keep Region Manager apprised of any site maintenance issues
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
The Expertise Required
- Strong organizational and planning skills to maintain a busy and diverse work schedule
- Proactive approach with the ability to work autonomously
- Excellent problem-solving skills
- The ability to multi-task and work well within a high-paced pressurized environment
- The ability to use your initiative to deliver a great customer experience
- Excellent communication skills paired with the ability to develop and nurture relationships
- Intermediate/Advanced IT skills including experience of using Word, Excel, Outlook and PowerPoint
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Ability to communicate and work effectively with a diverse team of professionals
- Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
- Critical thinker and problem solver
- Excellent interpersonal skills, detail-oriented and meticulous
- Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
- High level of self-motivation and energy
- Excellent professional writing and communication skills
- Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals
- Ability to work evenings and weekends as needed
- Must have access to reliable transportation
Certifications/Licenses, Education, and Experience
- Bachelor’s Degree or equivalent professional experience
- Research Professional Certification
- A minimum of 5 years of clinical research experience
- A minimum of 3 years prior Clinical Research Coordinator experience
- Previous Research Site Management experience preferred
- Spanish fluency preferred
How We Work Together
- Location: This is an on-site position with regional commute requirements.
- Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (<10%).
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $80,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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Site Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Site Manager is responsible for overseeing the day-to-day activities at the site under the direction of the Region Manager. The Site Manager is responsible for ensuring delivery of enrollment goals while maintaining adherence to FDA regulations, ICH guidelines, and CARE SOPs in all aspects of conducting clinical trials.
How You'll Make An Impact
- Management of Studies and Site Workload:
- Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols
- Coordinate Investigator and Sub-Investigator coverage
- Work with Region Manager to identify outside vendors needed for studies
- Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs
- Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
- Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up
- Update Region Manager on all pending and active study details
- Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely
- Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality
- Attend all study audits and play an active role in their management and execution of follow up items
- Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals
- Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
- Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input
- Personnel:
- Review and approve PTO requests, ensuring there is adequate coverage at the site
- Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
- Participate in the interview process for site staff
- Ensure site staff complete all required training
- Encourage a positive team-oriented environment
- Work with Region Manager to ensure high staff morale and low turnover rates
- Report all personnel issues to Region Manager
- Conduct weekly one on ones with staff and maintain appropriate documentation
- Lead by example and display a high level of integrity and professionalism.
- Financial:
- Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
- Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation
- Work with Region Manager to identify and communicate staff needs
- Ensure there are adequate supplies and equipment on site
- Site Maintenance:
- Keep Region Manager apprised of any site maintenance issues
- Coordinate building and equipment maintenance
- Ensure site is kept clean and organized: Professional for subjects and sponsor/CRO representatives
- Ensure staff are following guidelines and SOP’s as pertain to the sites
- Ensure that site have the equipment necessary to safely perform job responsibilities
- Work with the Region Manager to review and address injury reports if necessary
- Ensure the lab follows IATA guidelines and applicable staff are properly certified
- Collaborate and communicate with other departments regarding inter-site issues
- Keep Region Manager apprised of any site maintenance issues
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive
The Expertise Required
- Strong organizational and planning skills to maintain a busy and diverse work schedule
- Proactive approach with the ability to work autonomously
- Excellent problem-solving skills
- The ability to multi-task and work well within a high-paced pressurized environment
- The ability to use your initiative to deliver a great customer experience
- Excellent communication skills paired with the ability to develop and nurture relationships
- Intermediate/Advanced IT skills including experience of using Word, Excel, Outlook and PowerPoint
- Excellent working knowledge of medical and research terminology
- Excellent working knowledge of federal regulations, good clinical practices (GCP)
- Ability to communicate and work effectively with a diverse team of professionals
- Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
- Critical thinker and problem solver
- Excellent interpersonal skills, detail-oriented and meticulous
- Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
- High level of self-motivation and energy
- Excellent professional writing and communication skills
- Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals
- Ability to work evenings and weekends as needed
- Must have access to reliable transportation
Certifications/Licenses, Education, and Experience
- Bachelor’s Degree or equivalent professional experience
- Research Professional Certification
- A minimum of 5 years of clinical research experience
- A minimum of 3 years prior Clinical Research Coordinator experience
- Previous Research Site Management experience preferred
- Spanish fluency preferred
How We Work Together
- Location: This is an on-site position with regional commute requirements.
- Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal (<10%).
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $80,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is critical in translating Neuralink’s BCI technology for clinical use!
Job Description and Responsibilities:
As a Clinical Program Manager, you will be the primary architect of Neuralink’s human clinical trial operations, transforming high-level strategy into rigorous, executable clinical programs. We are seeking a high-autonomy leader who thrives on ambiguity and drives projects to completion with surgical precision. In our hyper-dynamic environment, you aren't just managing timelines—you are building the infrastructure for the future of neurotechnology. You will be expected to:
Strategic Oversight & Relationship Management
- Act as the Principal Lead for complex clinical programs, owning end-to-end delivery and ensuring all milestones align with broader organizational objectives.
- Cultivate High-Stakes Partnerships across internal engineering and regulatory teams, as well as external vendors, strategic partners, and world-class clinical research sites.
- Champion Stakeholder Readiness by overseeing the training and credentialing of cross-functional teams, ensuring every contributor is equipped to operate within the trial’s rigorous requirements.
Operational Excellence & Scalability
- Engineer Scalable Frameworks to expand clinical operations across diverse global geographies, prioritizing safety, quality, and regulatory compliance at every inflection point.
- Lead Commercial & Financial Negotiations with trial sites, driving contract execution, budget optimization, and long-term financial planning to maximize trial efficiency without compromising site engagement.
- Drive Data Intelligence by leading the synthesis and analysis of clinical data to provide actionable insights for program refinement.
Compliance & Regulatory Stewardship
- Navigate Global Regulatory Landscapes to secure study approvals and maintain impeccable standing with Institutional Review Boards (IRB), Research Ethics Committees (REC), and relevant governing bodies.
- Enforce Rigorous Quality Standards, maintaining an expert-level command of Good Clinical Practices (GCP), international regulatory requirements, and site-specific Standard Operating Procedures (SOPs).
- Foster a Culture of Accountability, proactively identifying operational risks and implementing mitigation strategies to ensure the integrity of the clinical program.
Required Qualifications:
Strategic Leadership & Clinical Expertise
- Extensive Industry Tenure: 7+ years of progressive leadership experience in clinical research, specifically within Class III medical devices, neurology, or high-complexity life sciences.
- Clinical Architecture: Advanced proficiency in clinical study design, endpoint selection, and the development of robust data analysis plans for first-in-human or pivotal trials.
- Regulatory Mastery: Deep technical knowledge of Global Good Clinical Practice (GCP) and international regulatory standards (e.g., ISO 14155, MDR, FDA 21 CFR Part 812).
Data Intelligence & Analytical Rigor
- Quantitative Fluency: Professional experience leveraging statistical methods or programming languages (Python, R) to drive data-led decision-making and trial optimization.
- Complex Problem Solving: Proven track record of interpreting multi-dimensional datasets and translating complex scientific findings into executive-level strategy.
- Meticulous Precision: A high-level of organizational rigor with the ability to manage competing high-priority workstreams in a fast-paced, high-stakes environment.
Communication & Interdisciplinary Integration
- Cross-Functional Catalyst: Demonstrated success leading integration between neural engineering, clinical neurosurgery, and regulatory affairs to achieve unified program goals.
- Scientific Diplomacy: Exceptional written and verbal communication skills, with the ability to distill complex technical and clinical concepts for diverse audiences, from internal engineers to external ethics committees.
- Operational Autonomy: A self-starting leader who initiates critical workstreams independently and maintains a relentless focus on deadline accuracy and operational efficiency.
Mission-Critical Mindset
- High-Stakes Resilience: A documented history of thriving in high-pressure, rapidly evolving environments where pivots are frequent and the margin for error is razor-thin.
- Advocacy & Influence: Strong presence and "scientific diplomacy" skills, with the ability to represent Neuralink’s clinical vision to world-class neurosurgeons, key opinion leaders (KOLs), and global health authorities
Preferred Qualifications:
Advanced Academic & Technical Background
- Advanced Degree: PhD, MD, or Master’s degree in a relevant field (e.g., Neuroscience, Biomedical Engineering, Clinical Research, or Biological Sciences).
- Neurotech Specialization: Direct experience managing clinical trials for Class III active implantable medical devices (AIMDs), specifically Brain-Computer Interfaces (BCI) or Neuromodulation systems.
- Computational Fluency: Advanced proficiency in Python or R for automated data visualization, clinical dashboarding, or sophisticated statistical modeling.
Strategic Clinical Leadership
- First-in-Human (FIH) Mastery: Proven success in leading Early Feasibility Studies (EFS) and navigating the unique safety and ethical rigors of pioneering human trials.
- Global Expansion Experience: Experience scaling clinical operations across international jurisdictions, including familiarity with O-US regulatory bodies and localized clinical trial infrastructure.
- Financial Stewardship: Demonstrated expertise in multi-million dollar budget management, including sophisticated resource allocation and vendor contract optimization.
Innovation & Process Design
- Clinical Systems Architecture: Experience implementing and optimizing Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and eTMF platforms for high-growth environments.
- Agile Clinical Operations: Ability to apply "lean" or "agile" methodologies to clinical trial workflows, reducing cycle times while maintaining absolute compliance.
- Interdisciplinary Synthesis: A rare ability to translate high-level engineering specifications into clinical protocols that are both scientifically rigorous and operationally feasible for surgical teams.
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Ready to apply?
Apply to Neuralink
About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!
Job Description and Responsibilities:
As a Clinical Scientist I, you will support the development, design, and execution of Neuralink’s clinical evidence strategy. This role focuses on translating product and research objectives into clinical study designs, supporting data analysis, and ensuring scientific rigor across clinical programs.
This individual is a self-driven and analytically strong individual who can contribute to clinical strategy while executing with precision. The ideal contributor is detail-oriented, collaborative, and comfortable working in a fast-paced, multidisciplinary environment.
In this role, you will:
- Support the design and development of clinical study protocols, including endpoints, inclusion/exclusion criteria, and statistical considerations
- Contribute to clinical strategy by translating research and product goals into evidence-generating study plans
- Partner with other team members to support execution of clinical studies and ensure alignment between scientific intent and operational delivery
- Build and maintain strong working relationships with internal teams, investigators, and external partners
- Support preparation of study-related documents, including protocols, investigator brochures, clinical study reports, and regulatory submissions
- Contribute to EDC and CRF design by ensuring alignment between protocol objectives, endpoints, and data collection strategy
- Translate clinical and scientific requirements into structured, high-quality data capture and validation approaches
- Assist in data review, analysis, and interpretation to evaluate safety and performance outcomes
- Contribute to development of abstracts, presentations, and publications
- Support interactions with ethics committees (e.g., IRB, RECs) and regulatory bodies as needed
- Ensure scientific and clinical activities are conducted in compliance with Good Clinical Practice (GCP), applicable regulations, and internal SOPs
- Identify data trends, inconsistencies, or risks and proactively communicate findings to the broader team
Required Qualifications:
- Familiarity with statistical methods or programming (e.g., Python, R)
- 5+ years of experience in clinical research or scientific roles within medical devices or related fields
- Strong analytical and problem-solving skills with the ability to interpret complex data
- Familiarity with clinical study design, endpoints, and data analysis concepts
- Working knowledge of Good Clinical Practice (GCP) and basic regulatory requirements (e.g., ISO 14155)
- Ability to work cross-functionally with clinicians, engineers, and operational teams
- Strong written and verbal communication skills, particularly in scientific and technical contexts
- High attention to detail and ability to manage multiple priorities
Preferred Qualifications:
- Experience with neurological, neurosurgical, or implantable medical device studies
- Experience supporting protocol development, data analysis, or clinical reporting
- Publications or scientific presentations in biomedical engineering or neuroscience
- PhD in neuroscience, biomedical engineering, or a related field
Additional Requirements and Competencies:
- Willingness to travel (up to ~20–30%) to support site visits, investigator meetings, and study activities
- Strong organizational and documentation skills
- Ability to work independently while collaborating closely with cross-functional teams
- Adaptability and comfort in a fast-paced, high-growth environment
- Commitment to scientific rigor, patient safety, and high-quality evidence generation
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Ready to apply?
Apply to Neuralink
Mechanical Engineer, Robotics (CONVOY)
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About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
The Convoy team, a specialized group within the Robot Mechanical Engineering team, is working on developing a first-of-its-kind brain-controlled assistive robotic arm (ARA). Our focus is on developing high-dimensional neural control of hardware, specifically robotic arms and hands. We design and integrate robotics systems, work directly with our clinical trial participants, and collaborate cross-functionally with hardware, software, electrical, and BCI engineers. We believe this work may be one of the best and most advanced paths to giving physical independence back to users with unmet medical needs.
Job Description and Responsibilities:
As a Mechanical & Robotics Engineer at Neuralink, you will design and produce hardware solutions for our assistive robotic arm. Your responsibilities may also include working on our brain-computer interface devices, surgical robotics, automation, microfabrication, and more. You will have the opportunity to own projects from concept to production, leveraging your mechanical engineering background in the challenging field of brain interfaces and human-robot interaction. Your responsibilities will include:
- Designing and integrating robot mechanical and electrical components and assemblies with a heavy emphasis on usability and safety
- Collaborating with clinical trial participants, neuroscientists, biologists, and engineers to establish design criteria
- Rapidly and effectively building systems to meet project goals
- Applying analytical methods, including calculations and simulations, for the design and optimization of structures and mechanical components
- Actively driving every phase of device launch, from hands-on early feasibility prototyping through manufacturing release
Required Qualifications:
- Bachelor’s degree in one of the following disciplines or equivalent experience: Mechanical Engineering, Robotics, Mechatronics
- Strong understanding of engineering first principles
- Minimum of 3 years of mechanical engineering industry experience, including internships and project teams where you owned products from concept to production
- Proficient in 3D CAD
Preferred Qualifications:
- Experience with robotic systems such as robot arms, grippers, actuators, human-robot interaction
- Multidisciplinary experience in robotics software and control (e.g., Python, ROS, MATLAB, control theory)
- Electrical engineering proficiency (e.g., PCB design, wire harnessing, circuit design)
- Proficiency with conventional machining and rapid prototyping technologies
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Ready to apply?
Apply to Neuralink
Software Engineer, BCI Applications
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About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
The Brain Computer Interface (BCI) Applications Team is responsible for delivering a product that gives people with paralysis the ability to control computers, phones, and robotic arms with their minds at the same speed and functionality level as able-bodied people can. The team works closely with the PRIME clinical study patients which allows them fast and direct feedback about new features from users. The work in the team is multidisciplinary and team members have diverse backgrounds in software engineers, design engineering, ML engineering and neuro-engineering.
Job Description and Responsibilities:
As a Software Engineer in the BCI team, you will collaborate with our users, specifically clinical trial participants, to comprehend their requirements and engineer brain-computer interface software systems that deliver exceptional user experiences. You will take the lead in creating innovative applications, implementing new features, and resolving existing issues to enhance the overall functionality of the software.
- Develop, test, and validate software systems
- Work with cross-functional teams to design new BCI functionalities and novel computer user interfaces
- Work with study participants to iterate on and further refine the software
- Mentor others in achieving engineering excellence and be a catalyst on the team through code review, design review, and technical presentations
- Write algorithms to decode brain activity
- Design user experiences centered around brain control
Note: The team is hiring software engineers at all levels, both junior and senior. What matters most is evidence of exceptional abilities and a drive to succeed.
Required Qualifications:
- Strong experience with full-stack development; experience with native (desktop/ Android/ iOS) preferred
- Strong experience in operating system knowledge in low latency concurrency programming, memory management and networking
- Fluent in programming languages such as Swift, Objective-C, Kotlin or Java
- Experience in architecting elegant, maintainable, performant and reliable user facing software applications
- Evidence in delivering high-impact projects to users or businesses with clear metrics and fast iteration cycle
- Evidence of exceptional ability in engineering
- Strong understanding of engineering first principles
- You are resourceful, flexible, and adaptable; no task is too big or too small
- Excellent communication and collaboration skills
- Bachelor’s degree in Computer Science or a related field or equivalent experience
Fast forward to 37:43 to learn more about software and UI:
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Ready to apply?
Apply to Neuralink
About Neuralink:
We are creating devices that enable a bi-directional interface with the brain. These devices allow us to restore movement to the paralyzed, restore sight to the blind, and revolutionize how humans interact with their digital world.
Team Description:
The Neuralink Clinical team is at the heart of an ecosystem that merges neuroscience, engineering, and medicine. We work to shape the future of brain-computer interface (BCI) technology through the planning, launch, and execution of groundbreaking human clinical trials. Our team is built on a foundation of excellence, aiming to uphold the highest standards of Good Clinical Practice (GCP) while redefining what’s possible and revolutionizing the way people interact with technology. Through strict compliance with ethical and regulatory protocols, we focus on ensuring the well-being of our trial participants while advancing the frontiers of neuroscience! Every day will bring fresh challenges and unprecedented opportunities to pioneer new approaches in the pursuit of our mission. From navigating regulatory pathways, designing trial protocols and documentation, and executing clinical trials, our team is instrumental in translating Neuralink’s BCI technology for use in people!
Job Description and Responsibilities:
As a Field Clinical Engineer, you will be on the front lines of Neuralink’s clinical programs, working directly with participants, clinicians, and internal teams to translate cutting-edge neurotechnology into meaningful functional outcomes. This role is ideal for individuals with a background in PM&R, occupational therapy, or physical therapy who also have experience in medical devices and thrive in dynamic clinical environments.
You will play a critical role in bridging clinical care, engineering, and research by supporting device use, optimizing participant performance, and ensuring high-quality data collection in both clinical and home settings.
This role requires someone who is hands-on, clinically grounded, technically curious, and able to adapt quickly. You should be comfortable working with participants with significant neurological impairments and motivated by improving independence and quality of life.
In this role, you will:
- Work directly with study participants to support device use, training, and optimization during clinical sessions and at home
- Apply principles of rehabilitation (PM&R, OT, PT) to maximize participant outcomes and functional performance with the system
- Collaborate closely with surgeons, investigators, and site staff to ensure seamless clinical execution across all phases of the study
- Serve as the primary interface between participants and the technology, troubleshooting issues in real time and escalating when needed
- Support surgical and post-operative workflows, including intraoperative and early post-implant sessions where applicable
- Ensure high-quality, protocol-compliant data collection by aligning participant activities with study endpoints and data capture requirements
- Partner with clinical, engineering, and data teams to translate real-world use into actionable insights for product and algorithm development
- Identify trends in participant performance, usability challenges, and safety signals, and communicate clearly to cross-functional teams
- Contribute to development and refinement of training protocols, user workflows, and clinical best practices
- Support site onboarding, training, and ongoing engagement to ensure consistency and scalability across clinical sites
- Assist in preparation for regulatory inspections and ensure activities are conducted in compliance with GCP, protocol requirements, and internal procedures
- Travel to clinical sites as needed to support study execution and participant care
The ideal candidate:
- Has a clinical background in PM&R, occupational therapy, or physical therapy, with hands-on experience working with neurological populations (e.g., SCI, ALS, stroke)
- Has experience working with medical devices in a clinical or field-based role
- Is highly adaptable, proactive, and comfortable operating in a fast-paced, evolving environment
- Is technically curious and able to engage with engineers to troubleshoot and improve system performance
- Communicates clearly and builds trust with participants, clinicians, and cross-functional teams
- Is detail-oriented and understands the importance of protocol adherence and data integrity in clinical research
Required Qualifications:
- Clinical training and hands-on experience in PM&R, occupational therapy, or physical therapy, with a focus on neurological populations (e.g., SCI, ALS, stroke)
- 3+ years of experience in a clinical, field-based, or medical device–adjacent role (rehab, neuromodulation, assistive technology, or similar)
- Demonstrated experience working directly with patients and clinicians in dynamic care environments
- Strong problem-solving skills with the ability to troubleshoot clinical and technical issues in real time
- Ability to interpret participant performance, functional outcomes, and device behavior to inform next steps
- Comfort working with technology, including basic data review and interaction with software-driven systems (no need to be a coder, but not afraid of one either)
- Working knowledge of clinical research principles, including protocol adherence, endpoint-driven activities, and data quality expectations
- Familiarity with Good Clinical Practice (GCP) and general clinical study conduct
- Ability to collaborate effectively across clinical, engineering, and operations teams
- Strong communication skills, with the ability to engage both participants and highly technical teams
- High attention to detail, with the ability to manage multiple participants, sites, and priorities simultaneously
- Willingness to travel frequently to support clinical sites and participants
Preferred Qualifications:
- Degree or formal training in bioengineering, biomedical engineering, or a related field, with exposure to neurotechnology or implantable systems
- Experience working with neuromodulation, brain-computer interfaces, or other neurorehabilitation technologies
- Prior experience in a clinical field engineer, clinical specialist, or applications role within a medical device company
- Experience supporting surgical procedures, intraoperative environments, or early post-implant programming and troubleshooting
- Familiarity with signal-based systems (e.g., neural data, EMG, EEG) and comfort interpreting system performance in real time
- Exposure to rehabilitation technology integration, including assistive devices, digital interfaces, or adaptive control systems
- Experience supporting multi-site clinical studies or working directly with investigators and study coordinators
- Comfort working with data systems (e.g., EDC platforms, basic data visualization tools) to review participant performance and study metrics
- Understanding of usability, human factors, and patient-centered design principles
- Prior involvement in training clinicians or participants on device use and workflows
- Experience working in early-stage or rapidly evolving clinical programs where processes are still being defined
Expected Compensation:
The anticipated base salary for this position is expected to be within the following range. Your actual base pay will be determined by your job-related skills, experience, and relevant education or training. We also believe in aligning our employees’ success with the company's long-term growth. As such, in addition to base salary, Neuralink offers equity compensation (in the form of Restricted Stock Units (RSU)) for all full-time employees.
What We Offer:
Full-time employees are eligible for the following benefits listed below.
- An opportunity to change the world and work with some of the smartest and most talented experts from different fields
- Growth potential; we rapidly advance team members who have an outsized impact
- Excellent medical, dental, and vision insurance through a PPO plan
- Paid holidays
- Commuter benefits
- Meals provided
- Equity (RSUs) *Temporary Employees & Interns excluded
- 401(k) plan *Interns initially excluded until they work 1,000 hours
- Parental leave *Temporary Employees & Interns excluded
- Flexible time off *Temporary Employees & Interns excluded
Ready to apply?
Apply to Neuralink