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

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

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.

We are looking for a highly motivated and innovative candidate for the role of Scientist / Senior Scientist of Analytical Development. The expectation is that the Scientist / Senior Scientist will have experience independently executing analytical experiments using HPLC/UPLC techniques. Reporting to the Associate Director of Analytical Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with a desire to conquer new challenges.

Primary Responsibilities:

• Leads development, execution, and validation of RP-IP/RP/IEX based analytical methods to establish identity, purity, potency, and stability criteria for early-stage mRNA and LNP formulations using UPLC-ESI-ToF, PDA, and CAD.
• Analyzes data and draws conclusions which drive screening, optimization, and scale-up efforts in mRNA and LNP Process Development.
• Serves as subject matter expert in analytical chemistry, mass spectrometry, and method qualification and transfer.
• Interfaces with external contract research organizations to ensure compliance with internal timeline and quality requirements.
• Mentors and develops junior scientists in analytical theory and in applications of analytical technology and software platforms.
• Created proprietary ToF mass spec oligonucleotide mass target and predictive sequence library software to rapidly profile known and identify unknown oligonucleotide mass signals.
• Maintains electronic notebook records and authors protocols.
• Contributes to data packages for regulatory submissions.
• Actively maintains current understanding of RNA and LNP landscape by attending conferences and other events.

Qualifications:

• B.S. or Advanced Degree in Chemistry, Chemical Engineering, Biology, Biochemistry, Molecular Biology or other relevant scientific discipline.
• 7+ years of experience with a focus on varying liquid chromatography modes (RP, RP-IP, AEX, SEC, etc), LC-MS, or capillary gel electrophoresis.
• Working experience in HPLC/UPLC method development.
• Experience with enzymatic and chemical reactions, PCR, plasmid processing, and standard analytical techniques for biologics or nucleic acid therapies.
• This position requires conducting laboratory experiments, excellent documentation review and writing skills, and the flexibility to work on multiple projects as needed.
• Understanding of process development, and/or regulatory aspects of mRNA-(lipid) nanoparticle products would be a plus.
• Ability to quickly adapt to change and thrive in a dynamic and entrepreneurial early-stage environment.
• A strong team player with excellent oral and written communication skills and a demonstrated ability to work independently.
• Independently motivated, detail oriented and good problem-solving ability.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $120,000 - $142,000 annually plus bonus and equity incentives

About the Role

As the Director, Site Performance & Solutions (Cardiology), you will report to the VP, Growth and own the performance of Iterative Health’s central clinical services that are delivered to our cardiology research sites as performance-enabling solutions, including pre-screening, regulatory support, and eSource. Your two core mandates are: owning the operating model for the central research support services we deliver to sites, and ensuring the network consistently hits and improves its activation and randomization targets.

This is a role for someone who is deeply grounded in research operations, relentlessly data-driven, and capable of diagnosing performance improvement opportunities quickly and implementing solutions at a high standard. You will serve as a “product owner” for our suite of site solutions, continuously improving how they are designed and delivered. When performance gaps emerge, you will be the person who figures out what is wrong and drives the fix.

Responsibilities

Network Performance Ownership

• Own activation and randomization performance across IH’s cardiology site network as the single accountable leader.
• Monitor site and network-level performance metrics continuously, identifying trends, risks, and gaps before they escalate.
• Understand the key levers that drive enrollment performance and ensure they are being optimized, consistently and systematically, across the network.
• When performance falls short, diagnose root causes quickly, develop a clear plan of action, and drive execution until the issue is resolved.

Operating Model & Solution Ownership

• Serve as the accountable owner for IH’s cardiology central research support services, including regulatory support, pre-screening and eSource.
• Own the design, execution, and continuous improvement of the operating model for each service, treating them as products with clear performance standards and measurable outcomes.
• Define and track service-level KPIs for each function; use performance data to surface improvement opportunities and raise the quality bar.
• Develop scalable workflows and best practices that can be deployed consistently across the network.
• Serve as the connective tissue between site-level performance trends and central service teams, ensuring the right resources are allocated where they will have the greatest impact.
• Collect and synthesize site feedback to inform service improvements and partner with cross-functional teams to implement solutions.

Team Leadership & Management

• Directly manage and develop a multidisciplinary team of clinical research specialists, e-source specialists, pre-screeners, and regulatory specialists
• Set clear goals and performance expectations for each function, provide ongoing coaching and development, and foster a high-performance team culture
• Ensure each team is properly resourced, trained, and equipped to deliver their services at the standard required to drive strong site outcomes

Required Qualifications

• BS/BA or higher degree
• 10+ years of clinical research experience, with deep familiarity with research operations and trial execution
• Demonstrated proficiency with clinical research systems and tools, including CTMS and pre-screening workflows
• Proven ability to use data to diagnose performance problems, identify improvement opportunities, and drive decisions
• Track record of building and improving operating models or service delivery processes in a clinical research context
• Proven people management experience, with a track record of leading, developing, and holding accountable clinical research teams
• Ability to manage multiple priorities, meet deadlines, and operate effectively in a fast-paced, evolving environment

Preferred Qualifications

• Prior experience in a director-level or senior management role within a site network, CRO, or health tech organization
• Experience owning enrollment or operational performance metrics at a network or program level
• Cardiology-specific clinical research experience

About the Role

As the Manager, Growth, you will play a critical operational role at the center of Iterative Health's two core growth engines in Cardiology: expanding our sponsor portfolio and scaling our site network. This is a high-visibility, high-impact role for a sharp operator who thrives on process ownership, cross-functional coordination, and getting things done in a fast-moving environment. You will own the internal mechanics of business development — keeping the pipeline moving, deals progressing, and sponsors well-served — while simultaneously driving the operational build-out of new clinical research sites from contract execution through first study activation. The ideal candidate brings a strategic and operational mindset, is energized by variety, and is able to manage multiple workstreams with rigor and speed.

Responsibilities

Sponsor Growth: Business Development & Alliance Management Support

• Own the end-to-end internal business development process from initial sponsor engagement through contract execution, serving as the single internal touchpoint for new contracts
• Keep the business development pipeline organized and visible by maintaining up-to-date reporting on opportunity status, next steps, and deal progression
• Support the Director of Research Partnerships in preparing for key sponsor interactions — developing pitches and proposals, building conference materials, and ensuring the team shows up well-prepared for high-stakes meetings
• Support sponsor account meetings through internal data gathering, performance reporting, and post-meeting follow-through
• Continuously identify opportunities to streamline and improve the business development process to accelerate deal pull-through and reduce time to contract close

Site Network Growth: De Novo Site Builds 

• Partner with the Director of Clinical Research to support the end-to-end process of standing up de novo clinical research sites 
• Serve as the operational connective tissue during site stand-up, tracking progress, surfacing blockers, and ensuring all cross-functional inputs come together on schedule
• Work with the Director of Clinical Research to continuously evaluate and improve the site stand-up process — identifying inefficiencies, building out playbooks, and creating repeatable frameworks that scale as the network grows

Required Qualifications

•  BS/BA or higher degree
• 4+ years of experience in a strategic and operational role, such as management consulting, business operations, or growth/strategy at a high-growth startup
• Demonstrated ability to own and manage complex, cross-functional processes end-to-end with strong attention to detail
•  Excellent organizational skills with experience managing multiple projects and workstreams simultaneously in a fast-paced environment
• Strong communicator with the ability to synthesize information, build materials, and engage effectively with internal and external stakeholders
• Comfortable working with ambiguity and building structure where it doesn't yet exist

Preferred Qualifications

• Experience in life sciences, clinical research, or healthcare 
• Familiarity with clinical trial operations, site networks, or sponsor/CRO relationships

About Every Cure:   

Every Cure is an AI-driven nonprofit, biotech organization on a mission to save and improve lives by repurposing existing medicines for diseases with significant unmet need. We are working to create a world where every drug is used to treat every disease it possibly can, so that no patient suffers when an existing treatment could help them. We are filling a gap left by the current biomedical system, which doesn’t systematically pursue new uses for old drugs. Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can. Inspired by Every Cure’s co-founders' work repurposing drugs for Castleman disease and other rare diseases, Every Cure is advancing repurposed treatments for neglected diseases and has been featured in The New Yorker,  New York Times, USA Today, Good Morning America and other news media. Led by a talented leadership team and an outstanding Board of Directors, Every Cure is supported through funding from leading philanthropic organizations like Chan Zuckerberg Initiative, TED’s Audacious Project, and ARPA-H. 

 Our approach:  

• AI-Powered Identification: We use advanced artificial intelligence to analyze the world’s biomedical knowledge and identify FDA-approved drugs that can be repurposed for untreated conditions. This cutting-edge technology enables us to explore new therapeutic possibilities efficiently.  
• Open-Source Commitment: We are dedicated to making our predictive pipeline open-source, fostering collaboration and transparency within the scientific community and unlocking the potential for discovering new treatments.  
• High-Impact Focus: We prioritize drug repurposing opportunities that will relieve the most suffering and have the greatest impact possible.  
• Rigorous Validation: Promising opportunities are thoroughly validated through laboratory and clinical studies to confirm their efficacy and safety before advancing to broader application.  
• Strategic Marketing and Access: We disseminate information about effective repurposed treatments through multiple channels and are committed to ensuring that new cures are accessible to all patients.

Applicants must reside in the state specified at the top of this job posting. Residency in that state is a requirement for consideration and must be maintained for the duration of employment.

The Head of Clinical Development leads Every Cure’s clinical research and development function, serving as both strategic architect and working clinical lead on priority programs. They manage a diverse portfolio of drug repurposing initiatives including Every Cure-sponsored interventional trials (with full sponsor IND accountability and REMS complexity where applicable), collaborative investigator-sponsored trials, and Every Cure-led patient registries, natural history studies, and other real-world studies. They collaborate directly with computational and data science teams to translate AI-driven repurposing hypotheses into clinically testable programs and represent the organization to external partners and stakeholders. This role owns sponsor compliance under ICH E6(R3) including maintenance of the clinical QMS and SOP infrastructure regardless of CRO engagement  and oversees regulatory strategy and dissemination. The HCD supports Every Cure’s CSO and engages directly with external stakeholders including CROs, clinical trial technology vendors, academic investigators, patient advocacy organizations, the IRB of record, and FDA. The HCD helps build and lead a lean internal clinical development team, modeling the working-leader norm expected in a small, mission-driven organization.

How you will make an impact: 

Strategic Leadership of Clinical Development and Medical Affairs

• Set the direction for Every Cure’s clinical research and development, ensuring alignment with the organization’s mission to repurpose FDA-approved drugs for high-impact unmet needs, while personally leading or co-leading priority programs.
• Lead the execution of organizational goals through operational planning and cross-functional integration, personally owning project timelines, quality standards, and accountability metrics for priority programs rather than delegating all execution.
• Provide expert counsel to the CSO, President and Scientific Advisory Council on medical strategy, program development, and organizational growth.

Research and Clinical Development Oversight

• Design, author, and review key study documents (protocols, statistical analysis plans, informed consent documents, clinical study reports, investigator brochures) for Every Cure-sponsored clinical trials, patient registries, natural history studies, and real-world evidence assessments. Own study design decisions end-to-end, from scientific rationale through data integrity and analysis.
• Serve as sponsor medical lead and/or medical monitor on Every Cure-sponsored IND-holding studies (delegating per-study where appropriate), ensuring all research activities are ethically sound, methodologically rigorous, and regulatory compliant under FDA 21 CFR Part 312, ICH E6(R3), and ICH E9 principles.
• Translate complex medical findings into strategic decisions regarding program continuation, optimization, or sunsetting, based on efficacy, feasibility, and patient impact.
• Responsible for compliance and oversight of the Human Subjects Research program at Every Cure, including IRB (Advarra) submissions and amendments, sponsor safety reporting (IND safety reports, DSURs), SAE adjudication, signal detection, and REMS program participation where applicable (e.g., lenalidomide).

Portfolio Strategy and Program Management

• Partner on strategic prioritization and dynamic management of Every Cure’s diverse portfolio of drug repurposing opportunities, applying a risk-adjusted, impact-oriented lens to maximize outcomes.
• Direct the progression of programs through clinical and dissemination stages, using insights from AI models and external scientific inputs. Personally lead CRO and clinical technology vendor selection, contracting input, and ongoing governance (joint steering committees, KPIs, oversight plans) for highest-priority programs.
• Develop and manage resource allocation frameworks across disease areas and therapeutic modalities, ensuring optimal investment of time, talent, and funding toward the most promising interventions.

Leadership and Team Development

• Build, mentor, and lead a lean, high-performing team of clinical research and medical professionals united around a shared vision of maximizing patient impact through drug repurposing, modeling a working-leader norm in which senior leaders contribute directly alongside their teams.
• Define roles, responsibilities, and performance standards for the clinical team while fostering a culture of excellence, integrity, psychological safety, and cross-functional collaboration.
• Promote continuous learning and growth through coaching, training programs, and development opportunities that build both individual capability and team effectiveness.

Stakeholder Engagement, Compliance, and Dissemination

• Act as medical spokesperson and lead regulatory interface for Every Cure in public, scientific, and regulatory forums (including FDA pre-IND and Type B/C meetings), promoting the organization’s mission and sharing results from preclinical and clinical programs.
• Cultivate and manage partnerships with CROs, patient advocacy groups, academic institutions, and regulatory agencies to ensure successful execution and wide-scale impact of therapeutic programs.
• Guide the regulatory approval and post-study dissemination strategies to ensure timely and effective translation of research into therapies accessible to patients, including peer-reviewed publications, policy briefs, and healthcare provider outreach.
• Partner with the Impact lead to provide input and perspective on dissemination and to engage with key stakeholders to ensure medicines reach patients.

What you bring to the team:

Education 

• MD or MD/PhD preferred; PhD DO, or PharmD acceptable

Work Experience (Two-Tier: Head of / VP)

• Minimum for Head of Clinical Development: 8+ years of clinical development experience post-MD (or equivalent), including service as clinical lead on at least one sponsor-held Phase 2 trial from protocol through database lock.
• Demonstrated leadership experience recruiting, mentoring, and managing cross-functional clinical teams, with explicit willingness and proven ability to work hands-on alongside direct reports in a small-organization setting.
• Expertise in drug development, clinical trial design (including interventional trials in rare or ultra-rare populations), and clinical decision-making.
• Sponsor-side experience running Phase 2 trials (distinct from CRO or academic investigator experience).
• Experience working across more than one therapeutic research area.
• Experience with small-sample trial designs and natural history or registry data.
• Proven leadership in driving strategic initiatives and cross-functional collaboration to advance scientific and organizational goals.

Preferred for Vice President designation:

• 12+ years of clinical development experience, including prior functional leadership at a sponsor (Executive Director, Head of, or VP level); multiple sponsor-held INDs led through Phase 2 or beyond; direct experience with REMS programs, risk-based monitoring, or similarly complex regulatory programs; and prior responsibility for building or scaling a clinical QMS under ICH E6(R3) or predecessor standards.

Skills 

• Proficiency in clinical research, real-world evidence assessments, evidence generation, patient registry design, clinical trial execution, and sponsor-side pharmacovigilance.
• Working knowledge of FDA IND regulations (21 CFR Part 312), ICH E6(R3) Good Clinical Practice, ICH E9 statistical principles, 21 CFR Part 11 for electronic records, and REMS program requirements; familiarity with EU CTR a plus.
• Exceptional communication and presentation abilities.
• Demonstrated ability to foster and sustain a collaborative, cross-functional culture grounded in shared organizational mission and values.
• Able to partner effectively with computational and data science teams and critically evaluate AI/ML-driven repurposing hypotheses for clinical translatability.
• Strategic thinker with a focus on urgency, efficiency, and impact.
• Passionate about Every Cure’s mission and values.
• Highly adaptable, thriving in a fast-paced, start-up environment.
• Explicit willingness to be hands-on: comfort authoring and reviewing key clinical documents (protocols, SOPs, CSRs), directly managing vendor/CRO relationships, and working alongside junior staff rather than exclusively through delegation. Candidates seeking a purely oversight or figurehead role are not a fit for this position.

Compensations & Benefits: 

• Your paycheck: Competitive salary based on experience, ranging from $250,000 - $275,000 annually. 
• Health and wellness: Comprehensive plans with medical, dental, and vision coverage, plus a Flexible Spending Account (FSA) for eligible healthcare expenses. 
• Future nest egg: A 403(b)-retirement plan with an employer match of 3.5% helps you save for your future. 
• Relax and recharge: Generous time off, including paid time off and paid holidays. 
• We have you covered: Comprehensive paid leave for family and medical needs, ensuring you have the support you need during important times. 

This role is based in Cambridge, MA, with an expectation of minimum 3 days per week in office.  

Every Cure is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, genetics, or any other characteristic protected by federal, state, or local laws.

What’s the opportunity?

Reporting initially to the Chief Medical Officer, the Associate Director, Data Management will serve as a key individual contributor responsible for leading and executing clinical data management activities across one or more clinical programs. This role will partner closely with key functions including Clinical Development, Clinical Operations, and external CROs to ensure high-quality, trial-ready data that supports LifeMine's clinical and regulatory objectives.

Key Responsibilities

• Serve as the Data Management lead on assigned clinical trials, overseeing all CDM activities from study startup through database lock.
• Develop, review, and maintain key data management documents including the Data Management Plan (DMP), eCRF specifications, data validation plans, and edit check specifications.
• Design and review electronic Case Report Forms (eCRFs) in collaboration with clinical, biostatistics, and medical teams.
• Lead CRO and vendor oversight for data management activities, ensuring deliverables are met on time and to quality standards.
• Develop and implement data review strategies including ongoing data cleaning, query management, and medical coding oversight (e.g. MedDRA, WHODrug).
• Collaborate with Biostatistics on the development of the Statistical Analysis Plan (SAP), TFL shells, and interim analysis deliverables.
• Support data transfers and reconciliation with external data vendors including central labs, ePRO/eCOA vendors, and pharmacokinetics providers.
• Ensure compliance with applicable regulations, guidelines, and industry standards including ICH E6(R2), 21 CFR Part 11, and CDASH/CDISC standards.
• Contribute to database lock activities including final data review, query resolution, and lock certification.
• Participate in regulatory submissions by providing data management input into clinical study reports (CSRs), INDs, BLAs, and NDAs.
• Partner with Clinical Operations to support site initiation visits (SIVs) and investigator meetings with DM-related content and training.
• Contribute to the development and continuous improvement of data management SOPs, processes, and best practices.

What you will need to be successful

• Bachelor's degree in life sciences, data science, or a related field required; advanced degree preferred.
• 8-10 years of clinical data management experience in the biotechnology or pharmaceutical industry.
• Demonstrated experience as a DM lead on Phase 1–3 clinical trials, including full lifecycle from study startup to database lock.
• Proficiency with EDC platforms (e.g., Medidata Rave, Medrio).
• Strong working knowledge of CDISC standards (CDASH, SDTM) and regulatory requirements (ICH E6, 21 CFR Part 11).
• Experience with CRO oversight and management of external data vendors.
• Familiarity with medical coding conventions (e.g. MedDRA, WHODrug).
• Strong attention to detail with excellent written and verbal communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced, dynamic environment.
• Experience in transplantation or immunology a plus.
• Willingness to travel up to 10–15% as needed.

We are looking for a Senior Clinical Data Engineer to join our Research Operations team, which drives the end-to-end execution of studies that drive new feature development and validation. You’ll manage the data that forms the foundation of our clinical trials—ensuring that data pipelines are fast, transparent, and comply with all applicable regulations. 

In this role, you’ll work at the frontier of R&D health sensing and gain hands-on experience with every part of the clinical database lifecycle: from design and validation through database lock and archival. Working closely with our regulatory, software, and science teams, you’ll raise the bar for how Oura runs clinical studies. 

This is a remote US role with a preference for candidates based on the East coast.

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations.

What You’ll Do:

• Oversee the clinical data lifecycle for a portfolio of studies: ensuring timelines and data integrity are maintained.
• Work closely with research project managers, algorithm developers, data engineers, and external vendors to align data management activities with broader trial objectives.
• Identify data-related risks and implement mitigation strategies, while driving process improvements and adopting emerging technologies as needed.
• Lead data quality management, query analysis, optimization, deduplication, auditing, and validation of regulated data ecosystems.
• Develop and oversee the design of Case Report Forms (CRFs) and electronic data capture (EDC) systems to ensure accurate, complete, and protocol-compliant data collection.
• Build the Clinical Data Repository that will form the backbone of all research and regulatory work at Oura

We would love to have you on our team if you have:

• 7+ years of industry experience with clinical data management
• Fluency with regulations such as ICH GCP, 21 CFR Part 11, and standards such as CDISC (SDTM/ADaM)
• Proficiency in an industry-standard EDC system (e.g. Medidata Rave, Castor, REDCap) and data engineering tools (e.g. AWS S3, Glue, Athena; Databricks; Dagster; dbt)
• Experience bridging clinical data management and research with enterprise practices and standards
• Comfort with building dashboards using tools like Tableau or Databricks
• Flexibility with scheduling to enable calls with global collaborators

Benefits 

At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.

What we offer:

• Competitive salary and equity packages
• Health, dental, vision insurance, and mental health resources
• An Oura Ring of your own plus employee discounts for friends & family
• 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
• Paid sick leave and parental leave

Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future.

• Region 1 $172,550 - $203,000
• Region 2 $158,950 - $187,000
• Region 3 $147,900 - $174,000

A recruiter can determine your zones/tiers based on your US location.

We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI)

About the role: We are hiring frontline sales professionals to be part of a diverse and elite biopharma sales team dedicated to helping patients in need. With a laser focus on the eye care customer, the Territory Leader will be responsible for territory disease state education along with the launch and ongoing growth of XDEMVY. They will deliver high standards for the ongoing launch and beyond and will champion a culture of outstanding performance, compliance and full ownership of all activity and results. The Territory Leader will be experts in account management, business ownership, sales execution, resource utilization, and they will build and foster relationships with key eye care customers. The Territory Leader will relentlessly pursue excellence to maximize sales in their territory while learning to adapt to changes and needs of the business. In doing so, they will have the unique opportunity to meaningfully contribute to the growth and performance of Tarsus. This critical sales role will be ideal for someone who thinks strategically, operates with tactical precision and strives for excellence.

Geography: Candidates must live in Worcester, Framingham, Wellesley, Waltham 

Let’s talk about some of the key responsibilities of the role:

Account Management & Eye Care Experts

• Experts in eye care clinical information: anatomy, disease state, products, XDEMVY and office treatment patterns
• Experts in selling skills and account development including building relationships with all key stakeholders
• Experts in pull through tactics with a full understanding of managed care hurdles
• Understand all functions within an ophthalmology/optometry practice and how their roles impact product prescribing and pull through
• Maximize managed care opportunities within the territory and have an understanding of how it impacts the District, Region and Nation and share important feedback
• Understand key opinion leaders within respective geographies and foster engagement with Tarsus leadership
• As eye care experts, champion compliant promotion in alignment with our corporate values

Business Acumen & Sales Execution

• Drive top tier execution by exceeding sales performance goals and key productivity metrics across the territory
• Use expert analytical skills to guide highly productive activity – prioritize key customer engagements, drive reach and frequency to extend depth and breadth of product trial and utilization
• Drive a successful launch and ongoing performance by monitoring all key performance metrics weekly, monthly, quarterly, and annually – ability to adjust approach as needed based on data
• Ensure actionable business plans are set - align all selling activities to drive impact
• Share ongoing insights with leadership and internal stakeholders to ensure feedback is captured
• Personal accountability for driving the highest standards of ethics and compliance

Business Owners & Culture Champions

• Drive our culture of commitment, empowerment and teamwork which includes extreme ownership, high accountability, continuous improvement and relentless pursuit of excellence
• Achieve success and be prepared to adapt in a complex selling environment partnering with many stakeholders: district leaders, marketing, market access, medical affairs, sales ops, inside sales, training, and other important stakeholders
• Provide frontline feedback and intel to sales leadership and the broader organization
• Ensure PDMA compliance and adhere to all company & industry compliance guidelines
• Share ongoing best practices among peers and leadership to elevate national performance
• Maximize all key resources that lead to territory success

Factors for Success:

• Bachelor’s degree in business, science, or related field or commensurate experience
• 2+ years pharmaceutical sales / relevant healthcare sales experience or a proven track record of business to business sales - required
  • Proven track record of pharmaceutical launch experience - strongly preferred
  • Eye Care experience- preferred
• Established track record with evidence of excellent problem solving and collaboration
• Highly adaptable to change, able to quickly pivot and respond given new market information in a fast-paced environment
• Strong communication and change management skills
• Proven ability to escalate difficult issues and make tough decisions
• Established track record in the following job competencies:
  • Selling skills
  • High performance
  • Impact & influence
  • Customer focus & account management
  • Maximizing resources
  • Analytical skills
  • Relationship building
  • Decision making & judgment
  • Teamwork & collaboration
  • Adaptability & GRIT

A Few Other Details Worth Mentioning:

• This is a field-based position reporting to the District Sales Leader
• Geography: Candidates must live in Worcester, Framingham, Springfield, Pittsfield
• Travel will be required within the selling geography and beyond to sales meetings, possibly across various customer conventions and occasional travel to HQ in Irvine CA
• 40% - 50% travel required in some larger geographies
• Territory Leader Salary Range;
• • Associate Territory Leader – 2+ years proven B2B selling - $110,000
  • Territory Leader – 1-2 years pharma selling - $123,000
  • Territory Leader – 2-5 years pharma selling - $139,000    
  • Sr. Territory Leader – 5-8 years pharma selling - $145,000            
  • Sr. Territory Leader – 8+ years pharma selling - $161,000

At Tarsus, we understand the importance of attracting and retaining top talent. In addition to a competitive base pay, we offer an incentive bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot.

#LI-Remote

About the Role >>> Associate Director, GCP Quality Assurance   

As the Associate Director, GCP Quality Assurance, reporting to the Senior Director GCP Quality Assurance, you will be partnering with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance. This will include identifying and communicating clinical trial-related risks and opportunities for process improvement, as well as reviewing / approving study-related documents and plans and supporting audits.  

This hybrid role is based out of either our San Francisco, CA or Cambridge, MA office and requires up to 20% travel. 

Your work will primarily encompass: 

• Performs internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines 
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs), communicate audit results to internal stakeholders  
• Partner with QA leadership during regulatory authority inspections and drive  GxP inspection readiness activities 
• Oversees quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP 
• Prepare for health authority inspections, suppliers and or clinical sites 
• Oversee clinical compliance and quality within the context of cross-functional study teams 
• Continue to improve/refine Olema’s risk-based GCP compliance approach globally 
• Manage Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls 
• Draft, review, and approve policies, procedures, and work instructions 

Ideal Candidate Profile >>> Key Requirements 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s Degree or higher in a scientific discipline 
• Strong understanding of clinical trials and pharmacovigilance reporting  
• In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 
• Understanding of industry quality management tools, quality systems (e.g., QMS, eTMF, EMRs, EDC, etc.) 

Experience: 

• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment 
• Demonstrated experience leading and/or conducting internal and external QA audits developing and executing risk-based audit plans 
• Demonstrated ability to develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors 
• Hands-on experience with regulatory inspections and inspection readiness activities 
• Experience writing and reviewing SOPs 
• Experience using QMS (Veeva systems preferred) 
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations. In addition, preferred Good Laboratory Practice (GLP) experience 
• Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines 

Attributes: 

• Excellent verbal and written communication skills 
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members 
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines 
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects 
• Ability to work hands-on and be a strong individual contributor 

The base pay range for this position is expected to be $190,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

Job Title: Executive Medical Director, Clinical Development         

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          .          

Role Overview: The Executive Medical Director of Clinical Development plays a key role in leading the design, execution, and oversight of clinical trials at an asset level, ensuring high-quality data generation to support the safety and efficacy of our pipeline products.  This role involves leading and developing a team and contributing to and influencing clinical development strategy across an asset, including study design, implementation, and data interpretation, while working cross-functionally to align clinical activities with overall development plans.  The Executive Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives in a fast-paced environment.  The role reports to the Vice President of Clinical Development. 

Key Responsibilities:

• Strategic Leadership:
• Drives the clinical development strategy for one or more assets
• Identifies critical clinical development milestones and ensures team alignment and accountability toward meeting timelines
• Provides leadership to the clinical team’s contribution to clinical study reports, key clinical documents, and regulatory submissions
• Directly manages and/or mentors Medical Directors, Clinical Scientists and other team members as appropriate
• Clinical Trial Design and Oversight:
• Leads and contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
• Oversees the conduct of clinical trials, ensuring adherence to protocols and good clinical practice (GCP) guidelines, working closely with CROs and external partners to ensure efficient execution
• Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug, driving timely, data-driven decisions
• Manages the clinical contribution to documents required during development (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
• Provides deep medical and scientific expertise in the therapeutic area, disease state, and potential drug effects 
• Reviews clinical data to identify and analyze safety concerns and adverse events, working with the pharmacovigilance team on continual benefit-risk assessment
• Stays current with relevant medical literature and clinical trial methodologies

• Contributes medical expertise to external interactions, including KOL engagement, advisory boards, and regulatory interactions as appropriate

• Cross-Functional Collaboration:
• Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pharmacovigilance, pre-clinical and project management teams to ensure alignment between clinical strategy and execution in a fast-paced environment
• Presents clinical data to internal and external stakeholders as appropriate
• People Leadership & Team Development:
• Leads and develops a high-impact team
• Provides coaching, mentorship, and performance management
• Fosters a culture of accountability, collaboration, and scientific rigor
• Supports hiring and resource planning in partnership with leadership

Qualifications:

• Medical degree (MD) ideally with board certification in a relevant specialty
• Extensive experience in clinical research and development, including within the pharmaceutical industry with progression of career demonstrating clinical leadership
• Proven people leadership experience, including managing and developing direct reports in small or growing teams
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements, ideally with Phase 2 and 3 clinical study experience
• Excellent communication, leadership, and analytical skills
• Demonstrated ability to contribute to and influence clinical strategy while driving hands-on execution 

Experience working in a small or emerging biotech environment, with comfort operating in a fast-paced setting

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $331,000 to $368,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

About the Role

We are seeking a highly motivated, proactive, strategic, and solution-focused Head of Clinical Operations. This hands-on position will lead and support all aspects of clinical trial operations including planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations, including direct management of outside Clinical Research Organizations (CROs) for several clinical stage oncology assets. In this role, the Clinical Operations leader will manage multiple priorities in a fast-paced environment and enact quick problem solving to ensure the successful conduct of clinical trials and the timely delivery of high-quality data. This role will oversee early and late phase trials with an emphasis on proactivity and creative solutions to overcome regulatory and operational hurdles. The successful candidate will have experience, and interest in, working in a small, dynamic environment with broad responsibilities.

Responsibilities

• Develop and lead a team of clinical operations professionals to ensure high-quality execution of early and late phase clinical trials and the professional development of team members.
• Serve as subject matter expert in clinical operations, providing guidance and expertise to cross-functional teams, including clinical development, regulatory affairs, and data management.
• Provide operational expertise and strategic input to Clinical Development Plans and support the overall clinical strategy for clinical programs. 
• Proactively communicate study plans, progress, risks and mitigations with senior leaders.
• Develop, implement, and modify when needed a successful resource and outsourcing model to meet the evolving demands of an expanding clinical portfolio.
• Manage study site selection, qualification, initiation, and monitoring activities to ensure that clinical trials are conducted according to the study protocol and in compliance with regulatory requirements.
• Evaluate and negotiate budgets, oversee selection and provide oversight and management of CROs, consultants and vendors to ensure the effective and timely execution of clinical trials, with high quality (including inspection ready) and within agreed budget.
• Monitor progress of clinical activity and report on the progress of clinical trials including budget, timelines, enrollment, and data collection / review. 
• Participate in the creation, review, and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
• Coordinate the delivery of clinical trial supplies in collaboration with CRO and other company team members.
• Develop and maintain strong relationships with clinical investigators and study site staff to ensure site performance, patient enrollment, and data quality; perform periodic visits to sites and/or vendors to assess progress and compliance.
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial and provide subject matter expertise for regulatory inspections.
• Maintain knowledge across the clinical operations team of program specific therapeutic areas, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities and appropriate communication to study sites.
• Proactively implement process improvements and innovative approaches. Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.

Qualifications:

• Bachelor’s degree (BA/BS) in a relevant scientific field (e.g. nursing, biology, biochemistry, or related areas); advanced degree preferred.
• At least 15 years of experience of successfully leading studies within clinical research operations. Experience with both small and large biotechnology companies is favorable.
• Experience in Phase I-III oncology clinical studies. Global experience preferred.
• Demonstrated expertise building and managing clinical operations teams.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Experience with agency submissions and inspections, understands adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations.
• Forward thinking mindset with ability to manage multiple projects, identify and resolve issues.
• Strong analytical, organizational, and time management skills with a track record of identifying and implementing novel solutions and problem-solving.
• Demonstrated agility and ability to navigate and be successful in a fast-paced, dynamic work environment.
• Proven hands-on leadership and communication skills (written and verbal).
• Team player who collaborates effectively with internal stakeholders as well as external contract organizations.
• Be a champion of a highly collaborative, transparent, data driven, “make it happen” culture.

This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $319,333 - $375,665. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through Skype or Telegram.
• Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

**We are only hiring for this role in the CST or EST time zones**

At Greenlight Guru, we help the world’s most innovative medical device companies bring high-quality, life-changing products to market faster. We serve 1000+ global customers with our quality management and clinical data capture software, helping them get their products on the market and keep them there. 

When you join the team at Greenlight Guru, you’ll be a part of a collaborative, mission-driven team working in one of the most exciting and rewarding industries on the planet. Backed by JMI Equity, one of the premier growth equity firms for SaaS companies, Greenlight Guru is growing—and looking for individuals who are difference makers. Is that you?

We are looking for a commercially-minded, revenue-driven, highly technical Solutions Engineer to join our organization with a heavy focus on selling to software engineering teams. Reporting to the Director of Product Marketing, you are responsible for translating our product strategy into confident, effective value-based selling. You will work alongside Sales to support live deals, bring product and technical depth into buyer conversations, and turn field experience into reusable assets that scale across GTM. You focus on the last mile of the buying journey - proving technical fit, reducing risk, and helping buyers move forward with confidence. While you are a strategic partner to Sales on active deals, being situated within the Product Marketing team allows you to act as a critical bridge between our product’s capabilities and our market-facing message. You are a technical storyteller who knows how to connect "how it works" with "why it matters." You’ll use real-world deal experience to stress-test and refine our positioning, competitive strategy, and the assets we use to win.

Responsibilities

Value Selling & Deal Execution

You own technical confidence in active deals and are accountable for buyer certainty in our technical fit. Your performance is largely measured by your impact on revenue.

• Technical Discovery & Diagnosis: Lead additional deep-dive discovery during demos to uncover a prospect’s current tech stack and pain points. You help diagnose the technical "why" before prescribing a solution.
• Value-Based Demonstrations: Deliver demos tailored to the buyer’s specific goals and success criteria. Lead with value and differentiation, not feature walkthroughs.
• Trial & Evaluation Ownership: Own the trial experience end-to-end, including setup, guidance, and success criteria. Ensure trials clearly demonstrate value and differentiation.
• Technical Deal Support: Act as a persistent partner in the deal, not a one-time resource. Stay current on deal status, identify technical risks, and partner with AEs to move deals forward.
• Expansion & RFP Support: Support expansions and at-risk renewals. Partner with AEs and PMM to ensure RFPs have high positioning impact and technical clarity.

Technical Assets & Demo Environments

You are responsible for maintaining the "technical sales toolkit," ensuring the GTM team has accurate, field-ready assets to sell efficiently.

• Scalable Asset Creation: Build and maintain reusable technical sales assets—such as walkthroughs, video snippets, and PoC templates for APIs/integrations—that help the field scale.
• Demo Environment Ownership: Maintain stable and accessible demo environments. You ensure demo data supports realistic, value-based storytelling for our core personas.
• Demo Narrative: Collaborate with PMM to ensure the core demo narratives are technically accurate and reflect how the product is actually used in the field.

Cross-Functional Collaboration & Enablement

You act as the resident technical authority, ensuring seamless alignment between the Product, Marketing, and Sales organizations.

• Cross-Functional Collaboration: Serve as the trusted technical lead for AEs, AMs, and CSMs. You are a strong collaborator who bridges the gap between technical details and GTM strategy.
• Product Readiness: Stay current on what’s shipping and why it matters. Translate new features into demo-ready flows, technical FAQs, and narratives for the GTM team.
• Field Intelligence Loop: Serve as the "voice of the buyer." Identify patterns in technical objections or competitive gaps and provide clear, actionable feedback to Product to influence the roadmap.

Candidate Profile

• Commercially Minded: You understand that technical depth exists to win deals and drive revenue.
• Strategic Partner: You know when to lead technically and when to support the broader sales strategy.
• Solution Storyteller: You can translate product capabilities into outcomes that actually matter to a buyer.
• Ownership Mindset: You treat deals, proof points, and internal process improvements as your personal responsibility.

Qualifications

• Technical Sales Experience: Proven track record delivering value-led technical demonstrations to software engineers and highly technical buyers, translating complex platform capabilities (APIs, integrations, developer workflows) into clear business and technical outcomes.
• Software Development Fluency: Strong working knowledge of modern SDLC practices, including requirements management, Git-based version control, CI/CD workflows, and release processes, with hands-on experience using Jira and similar developer tools (e.g., issue tracking, sprint boards, workflow configuration) in real engineering environments.
• API & Integration Literacy: Practical understanding of REST APIs, authentication methods, and system integrations - confident discussing how systems connect, how data flows between platforms, and how traceability or automation is maintained.
• Code Familiarity: Hands-on familiarity with code platforms (you have written or actively used code-based tools) and can speak fluently about repositories, commits, pull requests, and automation workflows.
• SaaS Background: Experience at a small-to-mid-sized SaaS company where you helped build or refine the SE function, processes, or demo environments - not just operate within an established structure.
• Revenue Impact: A clear track record of directly supporting revenue, advancing complex opportunities, and influencing deal outcomes in partnership with Account Executives.
• Learning & Ownership Mindset: Thrives in a fast-moving, evolving environment — actively seeks feedback, adapts quickly, rolls with change, and contributes ideas that help the team continuously improve how we sell and deliver technical value.
• Nice to Have: Experience in life sciences/medtech environments or running technical proof-of-concepts.

Benefits you’ll enjoy:

• Flexible Paid Time Off policy and working hours
• Home Office stipend for new hires
• Multiple Medical Insurance options, plus Dental and Vision
• 401k (with company match) 
• Equity Program Eligibility (based on role and/or tenure)
• Paid Maternity and Paternity Leave
• Disability insurance

Greenlight Guru is an Equal Opportunity Employer. Individuals seeking employment at Greenlight Guru are considered regardless of race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. If you need assistance or accommodations to submit your application for this position, please email careers@greenlight.guru.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

SUMMARY 

Manage Quality Approval (qualification) of vendors including R&D, GMP and treatment centers (apheresis collection centers and cell therapy labs) by performing qualification audits and routine (requalification) audits.

Oversee R&D compliance for Genetix clinical studies and Support other Quality Compliance functions, which may include but are not limited to:

• Planning and conducting internal audits
• Assisting with inspection readiness efforts
• Supporting GxP inspection readiness and regulatory inspections

RESPONSIBILITIES

• Collaborate with internal stakeholders (e.g., Apheresis Operations, Commercial, and Clinical Development) and external stakeholders to coordinate and prioritize audits
• Schedule and execute external and internal audits
• Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and applicable regulatory requirements
• Update approved vendor list, vendor and audit records and develop risk-based audit schedules
• Support annual budget development for outsourced audits
•  Manage Investigator Site Audit Plans for clinical studies
• Develop and present vendor metrics at Management Review
• Oversee R&D quality related activities
• Serve as QA contact for QMS records such as external and internal QMS records and lead investigations, deviations, change controls, and CAPAs, especially those involving CGT clinical operations, analytical activities, or site compliance related
• Serve as compliance lead for clinical studies
• Ensure QA supporting documentation is submitted to the TMF, as applicable
• Serve as QA contact for review and approval of Clinical SOPs
• Perform Regulatory Document Reviews, as applicable
• Provide quality oversight across CGT clinical studies, ensuring GCP compliance, data integrity, and proper documentation throughout clinical execution
• Ensure clinical trial sites are inspection‑ready and provide quality guidance to external partners, CROs, and CGT clinical facilities, ensuring alignment with internal quality standards and regulatory requirements.
• Act as the SME and primary point of contact for inspection management, providing real‑time regulatory guidance.
• Partner with Clinical Operations, Regulatory, and Vendor Management teams to identify and mitigate study specific quality risks throughout the trial lifecycle

QUALIFICATIONS

• 8-10 years of experience in gene therapy/cell therapy/biotech/or other related and regulated industry
• 8–10+ years of experience in R&D Quality
• Experience auditing investigator sites, GMP and R&D vendors and apheresis collection centers and cell therapy labs
• Knowledge of FACT/JACIE requirements
• Demonstrated experience in GCP compliance, clinical trial oversight, inspection readiness, and regulatory interaction
• Direct experience leading clinical deviations, CAPAs, change controls, and investigations
• Experience partnering with Clinical Operations, Regulatory, and cross‑functional stakeholders to manage clinical quality risks

 Preferred Qualifications

• Experience with CGT‑specific clinical QA such as:
• Apheresis and cell handling
• Chain‑of‑custody / chain‑of‑identity systems
• Strong understanding of CGT‑specific analytical and technical quality processes and technical Quality oversight.
• Excellent communication and stakeholder influence skills to support global, cross‑functional clinical programs

Job Title: Scientist/Senior Scientist, Upstream, Process Development & Manufacturing (Biologics)  

Location: Hybrid – Waltham, MA required to be in-office 3 days/week -OR- Remote

Position Overview: 

We are seeking an experienced and motivated Scientist/Senior Scientist to support upstream manufacturing activities. This role will be instrumental in contributing to process development and delivery of clinical trial material at CDMOs. The ideal candidate will collaborate cross-functionally within the CMC team including downstream, analytical, and drug product and other stakeholders such as QA, regulatory, and program management.  The successful candidate will help support CMC strategy in a fast-paced, innovative environment. You will be an integral part of a growing team with an opportunity to contribute towards developing best-in-class biotherapeutics.

Key Responsibilities

• Support cell culture process development and manufacturing activities at external CDMOs.
• Execute and support upstream process development, scale-up, and tech transfer to enable drug substance supply.
• Partner closely with CDMOs to execute fit‑for‑purpose upstream processes aligned with development timelines.
• Support planning and execution of drug substance manufacturing campaigns, including batch record review, sampling plans, deviations, investigations, and change management.
• Serve as person‑in‑plant (PIP) during key manufacturing campaigns to support real‑time issue resolution.
• Identify and mitigate technical and development risks using phase‑appropriate strategies.
• Manage upstream timelines and deliverables to ensure on‑time material delivery and effective cross‑functional handoffs.
• Apply phase‑appropriate QbD principles and analyze process data to support development decisions.
• Contribute to upstream sections of regulatory submissions (INDs, IMPDs).
• Travel up to 20–25% to support CDMO activities.

Qualifications

• PhD or Master’s degree in Engineering or Biological Sciences with ~3-5 years of experience in upstream process development and/or manufacturing of biologics.
• Strong hands‑on expertise in CHO cell culture process development, scale‑up, media optimization, and bioreactor operations; mAb experience preferred.
• Solid understanding of upstream process parameters, product quality attributes, and troubleshooting in clinical manufacturing.
• Experience supporting or leading upstream tech transfer to CDMOs.
• Familiarity with phase‑appropriate cGMP and development regulatory expectations.
• Demonstrated ability to analyze and interpret process and manufacturing data.
• Exposure to upstream process characterization (PC) and process performance qualification (PPQ) is a plus
• Strong written and verbal communication skills and ability to work effectively with cross‑functional and external partners.
• Self‑motivated, execution‑focused, and comfortable operating in a fast‑paced, early‑stage biotech environment.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $130,000 to $208,000, who will work in Waltham, MA or remote if not living within commutable distance to Waltham. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

Iterative Health is pioneering the use of artificial intelligence-based precision medicine in cardiology, with the aim of helping to optimize clinical trials. Ultimately, the company aims to establish more meaningful endpoints to serve as better predictors of both therapeutic response and disease outcomes. This is an exciting time in the Clinical Research industry! Our team is driving the advancement of research by implementing streamlined processes, with a mission of getting treatment options to patients in a faster, more efficient way.

The Clinical Research Systems Specialist is responsible for supporting our clinical trial service operations through the development, maintenance, and quality assurance of administrative clinical trial materials. 

What you’ll be doing: 

• Perform and maintain study builds within CTMS system(s) 
• Support clinical research sites within their CTMS 
• Support Clinical Research Specialists & clinical research sites in EHR prescreening and management of Patient Findings Report 
• Conduct quality review and user acceptance testing of study builds to ensure alignment with protocol, sponsor requirements, and internal standards
• Maintain databases/spreadsheets as necessary to facilitate tracking/documentation of departmental activities 
• Provide QC support for budget and contract team 
• Attend project meetings as needed 
• Read and understand each assigned protocol 
• Provide regular reports to advise leadership of quality issues and to guide process corrections & improvements 
• Perform administrative duties in conformity with company policies and procedures
• Partner cross-functionally with clinical operations, regulatory, finance, and site teams to support study launch and execution.

Required Skills: 

• Clinical Research Coordinator experience
• Experience with CRIO, RealTime CTMS or similar clinical research technology platforms
• Attention to detail and thorough follow-up skills 
• Capable of handling and interacting with data in a confidential and compliant manner 
• Ability to competently use and learn software such as internet browsers, Adobe, Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams) and clinical trial management system (CTMS) 
• Intellectually curious 
• Hardworking, forward-thinking, credible, conscientious, and creative 
• Thrives when working within a high-paced, fluid environment 
• Excellent time management, planning, and organizational skills are required 
• Excellent written and verbal communication skills 
• High level of tact, integrity, and professionalism 

Preferred Qualifications: 

• Experience within a healthcare start-up preferable 
• Experience reading and understanding clinical research manuscripts and protocols
• Experience with vendor management 
• Familiarity with ICH GCP/GDP guidelines
• Familiarity with the following study documents: Budgets, CTAs, eCRF guidelines, lab manuals, pharmacy manuals, informed consent forms, annotated CRFs, etc.

About the Role

Accelerating clinical research is one of the defining challenges in healthcare. Promising therapies exist that patients can't access because the operational infrastructure to run clinical trials efficiently doesn't exist yet. We're building it. That means designing technology systems that bring order to a fragmented landscape of clinical data sources, automating the operational work that slows trials down, and turning real-world clinical data into a foundation for predictive intelligence.

We're looking for a Staff Software Engineer to own the design and implementation of the core systems that make this possible. This means building robust integrations across a complex, fragmented landscape of EHRs, CTMS platforms, and clinical data sources, each with its own data models, access patterns, and operational constraints. It also means building the data infrastructure that powers our predictive capabilities: the pipelines, feature stores, and training infrastructure that allow us to move from raw clinical data to models that meaningfully improve trial execution. This is a generalist role for someone who thinks in systems. You'll move between architecture and implementation, between integration engineering and ML infrastructure, between defining technical strategy and writing the code that proves it out. The problems are genuinely hard, largely unsolved, and what you build will matter.

This is an opportunity for someone who wants to be a part of a small, fast moving engineering team at a formative stage. You'll shape what gets built, how decisions get made, and what the team becomes.

Responsibilities

• Own the technical architecture for our core systems and build the foundational abstractions and interfaces that everything else is built on top of
• Build reliable integrations with dozens of external clinical data systems (EHRs, CTMS, eSource, labs), treating this as a hard systems design problem, not just an ingestion problem
• Build and evolve the infrastructure that supports model training and predictive capabilities, from ingestion through feature engineering and serving
• Move fast by prototyping to drive experimentation; derisk ideas quickly to keep the team building what works
• Evaluate and choose the technologies we build on: make build vs. buy decisions, select vendors, and shape our long-term infrastructure strategy
• Make the key technical tradeoffs between speed and durability, between generality and shipping
• Work across product, clinical operations, and data science to make sure you're solving the right problems, not just the interesting ones
• Help shape the engineering culture of a small, growing team: how technical decisions get made, how problems get debated, what rigor looks like in practice

What We’re Looking For

Required Qualifications

• Have 10+ years of software engineering experience, with significant time spent designing and building systems not just features
• Experience with healthcare data systems (HL7, FHIR, EHR/EMR integrations) or other highly regulated data environments
• Have 2+ years experience working in a high-growth startup environment
• Have deep experience with system integration, particularly across unreliable or heterogeneous external data sources
• Can think through and explain the full picture of a complex system while still being effective at the implementation level
• Experience using AI tooling and frameworks as part of your engineering workflow
• Have built data pipelines and infrastructure that support analytical or ML workloads in production
• Strong across the backend stack (Python, SQL, cloud infrastructure) and can pick up new tools and systems quickly
• Have built systems from early stages, making foundational decisions with incomplete information, not just extending established infrastructure
• Naturally raise the quality of the engineering around you through code review, architecture guidance, and honest technical conversation

Preferred Qualifications

• Experience building ML training infrastructure or feature platforms
• Familiarity with clinical operations, systems, or life sciences data
• SOC 2, HIPAA or similar compliance experience baked into engineering practice
• A track record of building systems that had to work correctly under real operational constraints, scale and complexity

About the Role

Accelerating clinical research is one of the defining challenges in healthcare. Promising therapies exist that patients can't access because the operational infrastructure to run clinical trials efficiently doesn't exist yet. We're building it. That means designing technology systems that bring order to a fragmented landscape of clinical data sources, automating the operational work that slows trials down, and turning real-world clinical data into a foundation for predictive intelligence.

We're looking for a Staff Data Scientist to be the person who understands our data deeply enough to know what's possible and curious enough to prove it. We have a truly unique data set within the industry, connecting clinical data (emr, endoscopic video, etc…) to trial data across 80+ trial sites. We're looking for someone who wants to dig deeply into this data - to understand its structure, its gaps, what it can tell us - and connect that understanding to real outcomes for sites and patients. The landscape is evolving rapidly, and the right person will have a point of view on how to apply new capabilities to our specific data and problems as they emerge.You'll work hands-on with the data, structure experiments, evaluate what's modelable, and directly influence what we build and how. This role sits at the intersection of data science, product strategy, and ML: you'll lay the foundation for our predictive capabilities and shape what that function becomes.

This is an opportunity for someone who wants to be part of a small, fast-moving engineering team at a formative stage. You'll shape what gets built, how decisions get made, and what the team becomes.

Responsibilities

• Work with clinical, video, and clinical trial operational data to understand what's there, what's meaningful, and how we can use it to drive a more efficient clinical trial system
• Design and run experiments that determine what's worth building
• Stay close to the evolving ML and model landscape and bring a point of view on how new capabilities apply to our data and problems
• Define the path from raw data to product and operationalization: what to model, how to evaluate it, and when it's ready to ship
• Partner with product and engineering to translate findings into concrete product decisions
• Identify opportunities where our data creates unique predictive advantages
• Evaluate where we should build, where we should partner, and where existing approaches fall short
• Help shape the engineering culture of a small, growing team: how technical decisions get made, how problems get debated, what rigor looks like in practice

What We’re Looking For

Required Qualifications

• 5+ years of experience in data science, applied ML, or quantitative research, with significant time spent hands-on with data
• Experience with healthcare data, clinical research, or life sciences
• A deep curiosity to understand data and connect it to the real world
• Deep experience designing and running experiments: you know how to structure a question, test it honestly, and draw conclusions that hold up
• Strong statistical foundations and the judgment to know when a result is meaningful versus interesting
• Fluent in Python and SQL, comfortable working across the data stack from exploratory analysis through to production-ready pipelines
• Experience working across data science, product, and engineering: you can influence what gets built, not just analyze what exists
• Have worked with complex, messy, real-world data and know how to make it useful without pretending it's clean
• Knowledgeable about ML capabilities and frameworks, with the judgment to know when something is genuinely applicable versus hype
• Can communicate findings clearly to technical and non-technical audiences, and make a persuasive case for what to build next

Preferred Qualifications

• Experience working at growth stage startups (strongly preferred)
• Experience with medical imaging or video data
• Familiarity with clinical trial operations, disease classification, or patient identification problems
• Experience building or defining the roadmap for an ML function from early stages
  • A track record of data science work that directly changed product direction

About the Role

Accelerating clinical research is one of the defining challenges in healthcare. Promising therapies exist that patients can't access because the operational infrastructure to run clinical trials efficiently doesn't exist yet. We're building it. That means designing technology systems that bring order to a fragmented landscape of clinical data sources, automating the operational work that slows trials down, and turning real-world clinical data into a foundation for predictive intelligence.

We're building a uniquely valuable data asset: real-world patient and research data flowing across 80+ trial sites, spanning dozens of EHRs and clinical systems, focused on patient populations that are chronically underserved by existing clinical research infrastructure. Your job is to build the pipelines, data models, and AI infrastructure that make this asset real, from ingestion and normalization through to the systems that power predictions on top of it. You'll own data quality and observability as foundational engineering problems. You'll also have a direct hand in shaping how this data drives our AI strategy, what we model, what we predict, and what becomes possible.

This is an opportunity for someone who wants to be part of a small, fast-moving engineering team at a formative stage. You'll shape what gets built, how decisions get made, and what the team becomes.

Responsibilities

• Own the data layer and architecture:  the models, schemas, and infrastructure decisions that everything downstream depends on
• Build and operate the pipelines and transformations that move data from ingestion through normalization, enrichment, and into the formats that support analytics, ML training, and production model serving
• Own data quality and observability: build the systems that make data issues visible and correctable before they compound
• Partner with ML and engineering teams to identify what's modelable, define training data requirements, and build the data foundations for new predictive capabilities
• Define how clinical and operational data is governed across the system
• Evaluate and select the tools and technologies that make up the data stack, with a clear point of view on build vs. buy
• Help shape the engineering culture of a small, growing team: how technical decisions get made, how problems get debated, what rigor looks like in practice

What We’re Looking For

Required Qualifications

• 10+ years of experience in data engineering or related roles, with significant time spent building data systems
• Experience with healthcare data strongly preferred (HL7, FHIR, claims, EHR extracts) or other complex, regulated data domains
• Deep experience modeling and integrating data from multiple heterogeneous sources with inconsistent schemas and quality
• Experience applying AI and LLMs to data engineering problems: extraction, normalization, classification, entity resolution
• Strong understanding of how data infrastructure supports ML workflows from feature engineering to training data pipelines to model serving
• Fluent in SQL and at least one modern programming language (Python, Java, Scala, Go), with experience across modern data infrastructure - distributed processing, streaming, cloud-native storage, orchestration, and transformation frameworks
• Have built data systems from early stages, making foundational decisions with incomplete information
• Naturally raise the quality of the engineering around you through code review, design guidance, and honest technical conversation

Preferred Qualifications

• Experience building data infrastructure that directly supports ML model training and evaluation
• Familiarity with clinical trial operations, EDC systems, or life sciences data
• SOC 2, HIPAA or similar compliance experience baked into engineering practice
• A track record of building or improving data systems that others had given up on making reliable

About the Role

The Manager, Pre-Screening owns the top of the patient funnel for Iterative Health studies, including leading indicators on screenings, randomizations, and funnel volume / health. They will manage a team who performs EHR chart review to identify potential candidates for trial enrollment and are responsible for ensuring that every trial Iterative Health supports receives the right pre-screening support. 

Responsibilities

• Execute human-in-the-loop component of EHR chart review and patient identification
• Develop and standardize EHR chart review processes and define metrics to measure quality
• Read and understand assigned study protocols to develop pre-screening approach and train team against
• Own strategy to increase impact of EHR chart review 
• Ensure team achieves high performance on key success metrics and make recommendations on how to scale team capacity 
• As needed, provide coverage for team and perform EHR chart review 
• Support team members by resolving immediate issues and providing first-level guidance
• Own requirement development with Product team related to technologies developed for pre-screening 

What We’re Looking For

Required Qualifications

• Experience managing a team
• Familiarity with clinical research protocols and manuscripts
• Experience with Electronic Health Records systems 
• Exceptional attention to detail and follow-up skills
• Ability to handle and interact with confidential data securely and compliantly.
• Proficiency in software such as internet browsers, Adobe, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams), and Salesforce

Preferred Qualifications

• Clinical Research sector experience preferred
• Familiarity with reading and understanding clinical research manuscripts and protocols
• Familiarity with reviewing electronic health record data
• Past experience working with Product teams to develop user requirements
• Experience within a healthcare start-up preferred

What We Offer

• Medical, dental, and vision insurance
• Life and disability insurance
• Parental leave
• Stock options
• Flexible work hours
• Unlimited paid time off
  
  

Our Commitment to Diversity
At Iterative Health, we’re building a team that reflects the diversity of the patients we serve. We are committed to fostering an inclusive and equitable workplace, including our hiring process. If you require accommodations during the application or interview process, please reach out to: CandidateAccommodations@iterative.health.

As the Clinical Operations Manager, you will report to the VP, Growth and work closely with our Clinical Research and Life Sciences teams to integrate Iterative Health (IH) services and AI solutions at clinical research sites throughout the US. This external-facing role will require strong communication, customer engagement and deep expertise in clinical research, in addition to a strong strategic skill set. You will engage with partners such as sponsors, CROs and key sites to drive executive operational alignment, providing strategic recommendations both internally and externally with a focus on improving research operations focused on biological sample collections trials. You’ll also be working directly with your portfolio of sites to deliver day-to-day support that encourages research best practices, drives the adoption of IH services and products, and ensures our sites achieve their research goals. 

Key Responsibilities: 

• Own end-to-end clinical research operations for biological sample collections trials, serving as the primary accountable party for trial execution quality and sponsor satisfaction outcomes
• Build and manage DCT (decentralized clinical trial) vendor relationships, including performance management, metrics tracking, and oversight to ensure biological sample collections trial delivery
• Own the information flow between sites and sponsors - including internal study education, site engagement protocols, and issue escalation pathways
• Serve as leading sponsor-facing owner for active studies - leading alliance management meetings by providing study updates, reviewing metrics, discussing site accomplishments and ongoing issues, and gathering information to relay to site-based staff, driving sponsor satisfaction, and owning escalation resolution
• Drive direct QC enforcement with site CRCs/staff, including data quality expectations-setting and direct communication on compliance gaps
• Own site performance improvement through metrics, change management, and direct intervention - proactively identifying and resolving performance gaps before sponsor escalation
• Demonstrate advanced knowledge of clinical research processes and tools, such as CTMS, pre-screening, and/or feasibility, and enhance these processes and outputs to effectively support our sites or internal teams. 
• Serve as a subject matter expert on clinical research workflows, in line with specific requirements of each protocol, optimized with Iterative Health (IH) services and AI solutions
• Support and lead weekly meetings with site-based staff to review enrollment progress, address operational issues, and provide guidance for performance improvement.
• Manage customer relationships with a high degree of professionalism and expertise ensuring timely responses, escalations of site issues, and building trust needed to help sites achieve IH goals
• Leverage IH solutions and services to help build best practice research sites, accelerate clinical trials, and build capacity at IH sites to execute high-quality clinical trials. 
• Deliver customized training for different clinical research user groups and devise process maps/workflows, tools, and techniques to help sites incorporate IH services
• Travel to customer sites to support study site activation, drive patient screening, and standby support for randomization activities 
• Collect, analyze, and communicate the voice of IH customer successes, concerns, and product adoption issues/competency gaps and collaborate with IH cross-functional teams to design and deliver solutions 

Required skills: 

• BS/BA or higher degree. 
• Minimum 4 years of clinical research coordinator experience
• At least 8 years of experience with biological sample collection trials and/or phase 2-4 pharma-sponsored clinical trials, including study start-up, CDA, feasibility, regulatory/standard operating procedures, study protocols, and regulations governing clinical research 
• Experience coordinating, evaluating, and following patients’ participation through clinical trials.
• Fluent in the use of Microsoft Office/Google Apps products. 
• Ability to navigate ambiguity and willingness to be flexible/adapt to changing work environments. 
• Desire to work with new tools and technology
• Ability to manage multiple projects, meet deadlines, and adjust priorities appropriately.
• Willingness to travel to customer sites (~30%) 

Preferred skills: 

• 5+ years as a Clinical Research Coordinator (CRC) working with biological sample collections trials or equivalent experience
• Experience with CTMS systems - preferably RealTime, Clinical Conductor, or CRIO

About the Role

We are seeking a motivated and detail-oriented Clinical Research Finance Specialist to join our growing Finance team. This role partners closely with the Finance Manager to support end-to-end accounts receivable operations across sponsor-funded clinical studies and internal research sites.

You will own core transactional AR workflows, including monitoring sponsor and site-level accounts, supporting timely collections, posting cash in RealTime CTMS, and assisting with invoicing as needed. This role requires close collaboration with internal teams, research sites, and sponsors and CROs to ensure accurate billing, timely cash application, and prompt resolution of outstanding balances.

The ideal candidate thrives in a fast-paced clinical research environment and enjoys balancing hands-on execution with cross-functional collaboration and continuous process improvement.

Key Responsibilities

• Support day-to-day accounts receivable operations, including monitoring sponsor and site-level balances and assisting with timely collections
• Reconcile study-level balances and payment activity, identifying discrepancies and partnering with stakeholders to resolve issues
• Accurately post cash receipts and payment details in RealTime CTMS and related financial systems
• Prepare and issue invoices for study activities and services in coordination with sponsor communications and internal teams
• Communicate professionally with sponsors and CROs regarding billing questions, payment status, and outstanding balances
• Assist in the preparation of AR aging schedules, financial summaries, and internal reporting
• Support audits and financial reviews related to accounts receivable and billing activity
• Collaborate cross-functionally with Clinical Operations, Site Finance, and Accounting to clarify billing terms and deliverables
• Contribute to ongoing process improvements to enhance AR efficiency, accuracy, and visibility
• Provide general finance support as needed to ensure smooth AR operations

Required Qualifications

• Bachelor’s degree in Finance, Accounting, Business, or a related field (or equivalent practical experience)
• 2+ years of experience in accounts receivable, billing, or finance operations
• Strong proficiency in Microsoft Excel, including data analysis and reporting
• High attention to detail with the ability to manage multiple priorities and deadlines
• Excellent written and verbal communication skills, with a professional approach to external stakeholders

Preferred Qualifications 

• Experience with RealTime CTMS or similar clinical trial management and billing systems
• Background in healthcare, clinical research, or multi-site organizations
• Familiarity with sponsor contracts, clinical trial invoicing, or study-level financial reconciliation

Job Title: Senior Manager, Clinical Supply Chain (Biologics)         

Location: Hybrid – Waltham, MA. Candidates will be required to be in-office 3 days/week.          

Role Overview: We are seeking an experienced and motivated candidate to execute clinical supply chain activities in support of early-to-late-stage clinical trials. In this role, you will be responsible for overseeing labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies. You are an ideal candidate for this role if you enjoy working in a fast-paced, high-touch environment establishing strong relationships across CMC, Clinical, Program Management, Regulatory and Quality. You will be reporting to and working alongside the head of Clinical Supply Chain to help establish Clinical Supplies processes and best practices, while supporting multiple clinical trials across US, Canada and EU. You are highly communicative and motivated to produce results effectively, efficiently and early to support global clinical supply chain activities in support of vials and pre-filled syringes.

Key Responsibilities: 

• Execute clinical supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Author, review and/or approve clinical labels, packaging batch records, shipping documents, stability, clinical study, and pharmacy protocols
• Serve as subject matter expert to generate label texts, distribution lanes, randomization codes, packaging specifications, and designs in compliance with regulations and GMPs
• Support site initiation visits (SIV), trials and OLEs by providing timely delivery of supplies, CoAs, stability, expiration, handling and destruction information
• Plan and adapt to changes against clinical demands, trial and protocol changes, expiration, and inventory management
• Support clinical supply and logistics planning in support of global regulatory filings
• Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs
• Support clinical distribution across US, Canada and EU through both IRT and manual driven site shipments and depot transfers
• Verify with Quality the accuracy within blinded studies’ drug release, shipments & IRT setup
• Identify and execute process improvements through report development and SOPs
• Build strong relationships and partners with other leaders across CMC, quality, clinical operations, regulatory, and external CDMO/CPOs
• Serve as person-in-plant (PIP) during label and packaging campaigns
• 20-25% travel in support of diligence and campaign execution at the CPOs

Qualifications:

• Bachelor’s or Master’s in a scientific discipline with 6+ years of relevant experience in clinical supply chain and logistics
• Must have hands-on experience managing supply chain activities including but not limited to labeling, packaging, distribution, inventory management, forecasting, IRT initiation, maintenance and expiry of clinical supplies
• Experience with clinical supply chain involving cold chain products is a plus
• Exposure to support clinical supply activities involving vials or pre-filled syringes is a plus
• Demonstrated experience managing import/export for clinical studies in US, Canada and EU
• Strong clinical supply skills with operational experience in tracking multiple activities, deliverables, timelines, contracts and budgets
• In-depth knowledge of quality and regulatory aspects of clinical supply chain in support of simple to complicated multi country clinical studies
• Demonstrated track record of successful tech transfers to commercial CPOs with an eye towards late stage and commercial launch
• Excellent writing, organization, communication and people management skills with the ability to work effectively with a diverse group of internal and external stakeholders
• Must have a creative, organized and strategic attitude with the ability to work in a fast-paced environment

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work in Waltham, MA, is $161,0000 to $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

POSITION OVERVIEW:

Disc Medicine is seeking an experienced, versatile and highly motivated attorney to join our Legal team and help to build our business while mitigating risk through the efficient negotiation of a broad range of life sciences agreements.  The successful candidate will possess significant experience in drafting and negotiating complex and routine life science agreements, including master service agreements, research and development agreements, manufacturing agreements, license agreements, consulting agreements, confidentiality agreements, clinical trial agreements, work orders and other vendor agreements. This position will report to the Vice President, Corporate Counsel, and collaborate extensively across the company, including our commercial, medical, clinical, finance, and other teams.

RESPONSIBILITIES:

• Draft, review and negotiate a range of agreements, including master service agreements, research and development agreements, manufacturing agreements, license agreements, consulting agreements, confidentiality agreements, clinical trial agreements, work orders and other vendor agreements, across the company's business
• Collaborate with employees across the company with respect to contract requests in a manner that efficiently advances our corporate goals by promoting successful contract execution
• Pro-actively identify risks inherent in contract terms, including legal, financial and reputational risks, and develop practical, business-oriented solutions to appropriately mitigate such risks
• Provide legal interpretation of agreements and other related business matters and provide practical, business-orientated legal advice
• Develop and refine contract templates and assist with the administration/oversight of contract systems and processes, such as our contract management system, to ensure efficiency of operations
• Advise on other legal matters that arise across various functions within the company, as appropriate
• Interface with external legal resources, as appropriate

 REQUIREMENTS:

• D. from nationally accredited law school and admission in good standing to any state bar in the United States
• 10-12+ years of relevant experience in an in-house legal department within the biotechnology or pharmaceutical industry
• Strong negotiation, contract interpretation, and contract drafting skills
• Strong communication and interpersonal skills, including proven ability to interact effectively with individuals from multiple departments at all levels of the organization
• Demonstrated ability to handle multiple responsibilities simultaneously and perform at a high caliber in a fast-paced environment
• Commitment to professionalism and ethical conduct, including ability to handle confidential and/or sensitive information
• Self-motivated with the ability to work independently while executing on responsibilities within a highly collaborative environment
• Experience in an emerging, publicly traded company environment is a plus

Job Title: Associate Director, Clinical Operations

Location: Waltham, MA.  Hybrid 3 days/week onsite.

Role Overview:

We are seeking an exceptionally nimble and flexible Associate Director of Clinical Operations who has a track record of achievement across all aspects of trial setup and execution in a fast paced small biotech with limited infrastructure and resources.  The individual will successfully lead and optimize activity across multiple studies for Oruka Therapeutics and will support the Director of Clinical Operations in a specific therapeutic indication. This critical role demands a strategic leader who possesses a keen ability to "zoom in" on intricate operational details while simultaneously "zooming out" to maintain a holistic view of program progress and timelines. The successful candidate will be a proactive problem-solver, adept at navigating complexities, anticipating challenges, and implementing agile solutions to ensure our clinical trials remain on schedule and within budget. We are looking for a candidate that can demonstrate a high degree of integrity, pragmatism and is laser focused on commitment to study goals.  You should be comfortable being a ‘player/coach’ taking on tactical tasks as required in support of the program.

Our environment is dynamic, and each day presents new challenges and opportunities for growth.  This is a “hands-on” role, and the successful candidate will be able to work alongside team members, regardless of levels, to drive results.

Key Responsibilities:

Drive Study Execution

• Help plan and run clinical trials from startup through close-out
• Stay close to study timelines, milestones, and deliverables to keep things on track
• Identify risks early and work with the team to address them before they become bigger issues
• Step in where needed—whether that’s reviewing documents, following up with vendors, or troubleshooting site challenges

Work Closely with CROs and Vendors

• Partner with CROs and vendors on day-to-day execution
• Track performance and timelines, and follow up when things are off track
• Contribute to vendor selection and help ensure we’re getting what we need from external partners

Stay Close to the Details

• Review key study documents and plans with an operational lens
• Make sure studies are being run in line with GCP, SOPs, and regulatory expectations
• Support inspection readiness—keeping documentation organized and audit-ready

Help Keep the Program Moving

• Track study budgets and timelines at a working level
• Flag issues early and escalate when needed
• Help coordinate across functions (clinical, regulatory, data, etc.) so teams stay aligned

Be a Strong Team Contributor

• Work as part of a small, collaborative team where everyone contributes
• Take ownership of your areas and follow through on commitments
• Bring a practical, solutions-oriented mindset to challenges
• Willing to mentor within the Clinical Operations organization

This position will require travel up to 35% (Domestically and internationally)

Qualifications:

• BA/BS required in a scientific/medical field preferred
• A minimum of 8-10+ years of experience in managing global clinical trials at all stages of development
• Experience in immunological and dermatologic disease areas welcome
• Capable of managing direct reports from afar and study team members across multiple time zones and cultures-minimum of 1-2 years of line management experience
• Demonstrated ability to successfully manage and deliver clinical trials from start-up through close-out, including all financial tracking and reporting activities
• Demonstrated successful management and oversight of CROs and other service providers
• Deep understanding of clinical trial design, protocol development/ review, and running the clinical trial meetings
• Significant experience with cross-functional leadership and clinical teams, including leading data review, protocol deviation review, database lock, CSR development, and study reporting activities
• Strong vendor management experience required
• Experience in the management and maintenance of EDC, CTMS, IRT, ePRO, etc.
• Minimum of 5 years of project management experience.
• Experience with Quality Assurance, SOP and Study Plans writing, CAPA preparation, and closure
• Experience with a submission-ready eTMF, regulatory inspections and/or inspection-readiness activities
• Strong knowledge of GCP and working knowledge in ICH GCP E6 R2 regulations
• Strong project management experience and skills is preferred
• Demonstrate strong leadership, decision making ability, collaboration and cross-functional management skills, ability to multi-task in a dynamic and fast-paced environment
• Strong interpersonal, negotiation, influencing, problem-solving skills
• Excellent written and verbal skills required
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable-Smartsheet experience a plus
• Strong computer and database skills
• Clear and concise oral and written communication skills
• Excellent organizational skills and experience prioritizing conflicting demands
• Critical thinking, problem solving, ability to work independently.
• Consistently operate with urgency, clarity and conciseness
• Communicate effectively and articulate complex ideas in an easily understandable way

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:                                        

• Waltham, MA. Hybrid 3 days/week onsite

About the Role >>> Director, Clinical Monitoring Oversight 

As the Director, Clinical Monitoring Oversight, reporting to the Senior Director, Clinical Operations, you will provide strategic and operational leadership for global clinical site monitoring activities across Olema’s clinical programs. You will ensure that clinical monitoring – whether by internal teams, through Functional Service Providers (FSPs), or outsourced to Clinical Research Organizations (CROs) – is executed with high standards of quality and consistency while maintaining compliance with GCP regulations. You will oversee Olema’s Clinical Monitoring Oversight Leads, regional monitoring teams, and site performance. As the Director, Clinical Monitoring Oversight, you will develop and implement monitoring oversight strategies and standards for Olema’s clinical monitoring execution worldwide—driving operational excellence, data integrity, and inspection readiness across all trials with an emphasis on risk-based, data driven processes. 

This role is based out of either our Boston, MA or San Francisco, CA office and will require about travel 15% travel.  

Your work will primarily encompass: 

• Provide strategic direction and operational oversight of all global monitoring activities across Olema’s clinical programs 
• Oversee internal clinical monitoring oversight team and FSP vendor responsible for providing Regional Site Monitoring Leads (RSMLs), ensuring alignment, consistency, and accountability across global regions 
• Establish and maintain effective governance with the FSP partner, including performance management, risk mitigation, and continuous improvement in monitoring quality and efficiency 
• Define and implement Olema’s monitoring strategy, including risk-based and centralized monitoring approaches in alignment with ICH-GCP and regulatory expectations 
• Ensure global harmonization of clinical monitoring processes, training, and documentation across programs and regions 
• Develop and monitor key performance indicators (KPIs) and quality metrics to evaluate site performance, FSP delivery, and regional oversight effectiveness 
• Collaborate with Clinical Operations, Data Management, Clinical Quality, and Clinical Development to ensure monitoring activities are aligned with program objectives and timelines 
• Contribute to the development and review of key operational documents, including Monitoring Plans, Oversight Plans, Risk Management Plans, and audit/inspection responses 
• Proactively assess monitoring risks and implement mitigation strategies to maintain inspection readiness 
• Lead, manage, and mentor internal monitoring oversight staff, fostering collaboration, accountability, and continuous improvement 
• Serve as the Monitoring Oversight representative on cross-functional and governance teams, presenting program updates, risks, and mitigation strategies to senior management 
• Drive innovation and process optimization in monitoring oversight practices, including leveraging technology and data analytics to enhance quality and efficiency 

 Ideal Candidate Profile >>> 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor's or Master’s degree in a scientific discipline or a related scientific field is required 
• Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements related to monitoring and clinical trial conduct 

 Experience: 

• Minimum 12 years of clinical operations experience in the pharmaceutical or biotech industry 
• Minimum 5 years direct site monitoring experience (qualification, initiation, interim, and close-out visits) with strong understanding of site operations and clinical trial execution 
• Minimum 5 years in a role providing global monitoring oversight, including oversight of clinical site monitors, FSP/CRO management and oversight, monitoring quality metrics, KPIs, and governance, and a track record of driving performance improvement and corrective action plans 
• Experience overseeing regional monitoring functions and ensuring alignment across geographically distributed teams 
• Oncology experience is required  

 Attributes: 

• Demonstrated ability to manage FSP or CRO partnerships, including contract governance, KPI development, and issue escalation 
• Skilled in risk-based monitoring methodologies and the use of oversight tools and systems 
• Strategic thinker with excellent communication, leadership, and interpersonal skills, with the ability to influence cross-functionally and externally 
• Strong analytical and problem-solving abilities; adept at managing competing priorities in a fast-paced environment 

The base pay range for this position is expected to be $235,000 - $250,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits. 

#LI-CK1

Job Title: Medical/Senior Medical Director, Clinical Development (Multiple openings)        

Location: Remote OR Hybrid 3 days/week if located near office in either Waltham, MA or Menlo Park, CA will be required.          

Role Overview: 

The Medical/Senior Medical Director of Clinical Development plays a key role in the execution and operational oversight of clinical trials, ensuring high-quality data generation to support the safety and efficacy of our pipeline products. This role involves supporting clinical study design, implementation, and data interpretation while working cross-functionally to align clinical activities with overall development plans. The Medical Director collaborates closely with internal and external stakeholders to ensure trial execution meets regulatory, scientific, and business objectives.

Key Responsibilities:

• Clinical Trial Design and Oversight:
  • Supports the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods
  • Oversees the conduct of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines
  • Reviews and interprets clinical data to assess the safety and efficacy of the investigational drug
  • Authors and contributes to clinical and non-clinical documents required during the clinical development process (including but not limited to: Clinical Study Protocols, Investigator Brochures, Clinical Study Reports)
• Medical Expertise:
  • Provides medical expertise of the therapeutic area, disease state, and potential drug effects 
  • Reviews clinical data to identify and analyze safety concerns and adverse events, and makes appropriate recommendations to the team 
  • Stays current with relevant medical literature and clinical trial methodologies
  • Contributes medical expertise to external interactions with collaborators throughout the clinical development cycle  
• Cross-Functional Collaboration:
  • Works closely with other functions including clinical operations, regulatory affairs, medical affairs, biometrics, pre-clinical and project management teams to help ensure optimization of the clinical development process 
  • Presents clinical data to internal and external stakeholders
• Strategic Leadership:
• Contributes to the overall clinical development strategy
• Helps to identify critical clinical development milestones and helps the team to drive toward meeting or exceeding timelines
  • Leads the clinical contribution for clinical study reports, clinical documents and regulatory submissions
  • May oversee the work of Clinical Scientists working on the same or other programs

Qualifications:

• Medical degree (MD) with board certification in a relevant specialty
• Extensive experience in clinical research and development, ideally within the pharmaceutical industry
• Strong understanding of clinical trial design, GCP guidelines, and regulatory requirements
• Excellent communication, leadership, and analytical skills 

 Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for the Medical Director is $255,00-288,000 and for the Senior Medical Director $306,000 to $343,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

POSITION OVERVIEW

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research

The Medical Director is a leader of the Science37 clinical team. Working within the department of Medical Affairs, this individual is responsible for a broad range of activities across several core functions. We are seeking an energetic physician to help drive innovation in the clinical research ecosystem​​.  This is a full-time, remote position and the individual chosen to fulfill this role can work from home. 

DUTIES AND RESPONSIBILITIES

Duties include but are not limited to:

Science 37 studies

• Function as the Principal Investigator for clinical trials when Science 37 is executing studies as either a Direct to Patient Site or fully decentralized trial
• Function as a Sub-Investigator for clinical trials for therapeutic areas/ indications that align with clinical expertise/ experience when Science 37 is executing studies.
• Coordination with Site Operations Manager to identify, onboard and train investigators for Science 37 studies
• Educate and train Science 37 study team about target patient population and treatment paradigms for given indication for Science 37 studies

Support for Science 37 Commercial Team

• Collaboration with Business Development counterpart to review study opportunity synopses/protocols to assess fit/feasibility for decentralized trial model 
• Support Business Development counterpart during sponsor/client meetings and teleconferences
• Support Science 37 study opportunities as a subject matter expert in the development of study opportunity proposals

Regulatory Engagement

• Collaborate with Science 37 Regulatory Affairs team to engage the FDA and other global regulatory bodies regarding the decentralized trial model, and its acceptance for global studies
• Work with sponsors/collaborators to identify clinical endpoints that are fit for decentralized clinical trial conduct
• Collaborate with sponsors and regulatory bodies to migrate endpoints from clinic-based conduct and validate their use for in-home conduct 

Thought Leadership

• Serve as Science 37 representative for decentralized clinical trial and therapeutic area-specific expertise at industry/clinical conferences and webinars
• Publish peer-reviewed articles and white papers related to therapeutic area-specific expertise and the decentralized clinical trial model

QUALIFICATIONS & SKILLS

Qualifications 

1. Advanced degree in Medicine (MD or equivalent)
2. Board-certification in Med/Peds or Pediatrics
3. 7+ years of demonstrating clinical & research excellence within academia and/or pharma
4. Experience as a Principal Investigator with a focus on pharmaceutical-sponsored studies

Skills/Competencies

1. Expertise in project management - Demonstrates ability to successfully lead/manage research personnel. Proactive problem-solving abilities and follow through.
2. Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
3. Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to create and review protocols, programs, and assess the feasibility/pathway to success of a project.
4. Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive sponsor, project team members and internal Science37 relationships. Ability to conduct effective presentations.
5. Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. 
6. Practices professionalism and integrity in all actions – Demonstrates ability to foster concepts of teamwork, cooperation, responsibility, and flexibility to get the work done.
7. Other – Ability to communicate in English (both verbal and written).
8. Preferred knowledge of Spanish

REPORTING

• Position Reports to the Chief Medical Officer

Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration 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 law. 

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.

Submit your resume to apply!

Job Title: Clinical Trial Manager/Senior Clinical Trial Manager         

Location: Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.  Remote may be considered.

About Us: 

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger.  Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.  

Role Overview: 

Will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline.  Independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe. May serve as the clinical functional lead and lead clinical trial initiatives for Oruka's cutting-edge dermatology treatments.

Key Responsibilities: 

• Clinical Trial Management:
• Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
• Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.
• Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.
• In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
• Team Leadership:
• Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
• Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines
• Foster a collaborative team environment focused on operational efficiency and continuous improvement.
• Regulatory and Compliance Oversight:
• Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH-GCP guidelines.
• Support the preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents with functional leads.
• Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.
• Budget and Resource Management:
• Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
• Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
• Negotiate contracts and budgets with clinical vendors and investigators.
• Vendor and Site Management:
• Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
• Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.
• Perform risk assessment and management, addressing issues proactively to mitigate operational issues. 

Qualifications:

• Bachelor’s or Master’s degree in life sciences or a related field.
• 5-7+ years of experience in clinical operations, with a focus on managing complex clinical trials.
• Expertise in GCP and regulatory requirements.
• Strong leadership and team management skills. 

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for Manager level is $146,000 - $161,000 and Sr. Manager level is $161,000 - $187,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

• Hybrid 3 days/week if located near office in Waltham, MA or Menlo Park, CA will be required.  Remote may be considered.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

About the Role >>> Lead Senior Medical Writer 

As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific and regulatory documents supporting Olema’s oncology portfolio. This role requires strong cross-functional leadership, partnering closely with Clinical Science, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders to translate complex clinical and preclinical data into clear, accurate, and compelling content for regulatory submissions, medical communications, and scientific publications. In addition, you will drive consistency, quality, and timelines across deliverables, contributing to the overall medical writing strategy and supporting key regulatory and clinical milestones. 

This role is based out of our Boston, MA or San Francisco, CA office and will require 10-15% travel. 

Your work will primarily encompass: 

• Preparing and editing a wide range of scientific and medical writing deliverables, including but not limited to protocols, protocol amendments, clinical study protocols, investigator brochures, regulatory submission documents (e.g. IBs, DSURs, sections of IND/IMPD/MAAs), PowerPoint presentations related to the Medical Writing function
• Collaborating with internal stakeholders (clinical scientists, regulatory strategy, medical monitors, biometrics, medical affairs) to understand data, interpret results, and ensure accurate message conveyance
• Ensuring documents adhere to internal style guidelines, regulatory requirements (e.g., ICH, GPP), and appropriate therapeutic-area standards (e.g., oncology, breast cancer)
• Maintaining version control, track author/reviewer feedback, and delivering documents according to project timelines
• Providing  writing and/or QC editing support for associated submission documents (as applicable) to help elevate overall team deliverables
• Remaining current on therapeutic area (breast cancer / endocrine-driven tumors) trends, journal publications, and regulatory guidance relevant to oncology and women’s cancers

Ideal Candidate Profile >>>  

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Knowledge: 

• Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree (MS/PharmD/PhD) preferred
• Demonstrated and excellent scientific writing and editing skills — the ability to translate complex scientific data into clear, concise, accurate documents for varied audiences (regulatory agencies, KOLs, internal stakeholders)
• Familiarity with regulatory writing standards (e.g., ICH E3/E6, GPP)
• Oncology preferred 
• Veeva RIM experience is a plus 

Experience: 

• Minimum of 7+ years of medical or regulatory writing experience, oncology (especially breast cancer) preferred, or a closely related therapeutic area
• Strong project management skills: able to manage multiple deliverables, meet deadlines, handle feedback iterations, and coordinate with cross-functional teams
• Ability to work independently with minimal supervision, while also being a collaborative team player
• Detail-oriented, organized, with strong verbal communication skills
• Proficiency with standard technical and document-management tools (e.g., Microsoft Word, PowerPoint, Microsoft Excel, Smartsheet, Starting Point Templates, Veeva RIM)
• Prior experience in clinical-trial documentation for oncology (eg, IBs, protocols, DSUR and CSRs) preferred
• Experience working in hybrid/remote environments

Attributes: 

• Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
• Self-motivated and enthusiastic; fast learner who can identify project challenges and expeditiously change course as required in a fast-paced organization
• Strong communicator who can tailor messaging to diverse audiences
• Highly organized with strong attention to detail and follow-through
• Ability in building strong cross functional working relationships 

The base pay range for this position is expected to be $160,000-$175,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MT1

About the Role >>> Associate Director, Global Regulatory Strategy - International 

As Associate Director, Global Regulatory Strategy / International Regulatory Affairs, reporting to the Senior Director of Regulatory Affairs Strategy, you will contribute to the development and execution of regulatory strategies for Olema’s products in early to late-stage clinical development. You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.  

This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%

Your Work Will Primarily Encompass: 

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project teams and Study Execution Teams, providing regulatory input and ensuring alignment with program objectives and timelines
• Prepare and coordinate high-quality regulatory global submissions, including INDs, CTAs, amendments, annual reports, DSURs, Investigator Brochures, and briefing documents
• Under the supervision of the Senior Director, Regulatory Affairs, contribute to planning and execution of regulatory interactions with health authorities (e.g., FDA, EMA, Health Canada, MHRA), including meeting requests, briefing packages, and follow-up correspondence
• Monitor the global regulatory landscape to identify requirements, trends, and potential impact on Olema’s development programs
• Coordinate and maintain health authority reporting schedules in collaboration with cross-functional teams
• Partner with external vendors (e.g., CROs, regulatory consultants) to ensure high-quality and timely submissions
• Support development of Regulatory Affairs departmental policies, SOPs, and systems (e.g., Veeva) to enhance submission quality and efficiency
• Assist in risk assessment and mitigation planning for regulatory deliverables

Ideal Candidate Profile  

We are looking for a collaborative and driven Regulatory Affairs professional who thrives in a fast-paced environment and brings expertise in regulatory strategy

Knowledge: 

Bachelor’s degree in a scientific discipline required; advanced degree (MS, PharmD, PhD) preferred

Experience: 

• Minimum 10 years of related experience with a Bachelor’s degree; or 7 years and a Master’s degree; or a PhD with 5 years experience; regulatory affairs experience in the pharmaceutical or biotechnology industry
• Direct experience preparing and submitting clinical trial applications (INDs, CTAs) and managing regulatory authority correspondence 
• Knowledge of global regulatory requirements for clinical development (FDA, EMA, ICH guidelines)
• Oncology therapeutic area experience preferred
• Experience collaborating in cross-functional, matrixed teams 
• Experience working with CROs and other partners

Attributes: 

• Strong organizational, project management, and problem-solving skills
• Excellent oral, written, and presentation skills
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities
• Self-starter with the ability to work both independently and within teams

The base pay range for this position is expected to be $176,000 - $188,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-MK1

Job Title: Director, Clinical Quality Assurance

Location: Remote; Waltham, MA area candidates preferred. 

Role Overview:

The Director, Clinical Quality Assurance is responsible for providing strategic quality leadership, support, and oversight for Oruka’s clinical development activities, with primary focus on Good Clinical Practice (GCP) and related quality systems supporting clinical trials. This role will establish, improve, and lead phase-appropriate clinical quality processes, ensure robust oversight of clinical trial execution and vendor performance, and drive inspection readiness for global health authority inspections, including FDA Bioresearch Monitoring (BIMO) inspections.

This role will partner closely with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Regulatory Affairs, Medical Writing, and external service providers to ensure that clinical studies are conducted in accordance with GCP, applicable global regulations, internal procedures, and protocol requirements. The Director, Clinical QA will provide proactive quality input across the clinical trial lifecycle, support continuous improvement, and help build a quality-focused culture as the organization advances its pipeline.

 Key Responsibilities:

• Clinical Quality Oversight: Provide Clinical QA oversight for new and ongoing clinical studies to ensure compliance with GCP, applicable regulatory requirements, and internal procedures. Serve as the primary quality business partner to Clinical Operations and other development functions to identify, assess, and mitigate quality and compliance risks across the clinical trial lifecycle. Review key study-level documents for quality and compliance, including protocols, informed consent forms, investigator brochures, monitoring plans, vendor oversight plans, data review plans, study reports, and essential trial documentation. Support development and implementation of phase-appropriate clinical quality procedures and processes.
• Quality Systems Support for Clinical Development: Provide quality support for clinical deviations, protocol deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and change control activities related to clinical development. Ensure appropriate escalation, documentation, trending, and management visibility for significant quality issues. Partner cross-functionally to identify recurring themes, systemic risks, and opportunities for process improvement. Establish and maintain clinical quality metrics and dashboards to support management review and continuous improvement.
• Vendor and CRO Quality Oversight: Provide quality oversight of CROs, central laboratories, clinical software vendors, and other GCP-relevant service providers supporting Oruka’s clinical programs. Support qualification, selection, ongoing oversight, and performance evaluation of GCP vendors, including participation in vendor audits or due diligence activities as needed. Contribute to vendor governance processes to ensure appropriate quality expectations, responsibilities, and issue escalation pathways are defined and maintained.
• Audit Program Execution: Develop and execute a phase-appropriate GCP audit strategy and annual audit program based on risk, program priorities, and business needs. Conduct and/or manage investigator site, vendor, study-specific, and for-cause audits as needed. Author audit plans, reports, observations, and follow-up actions, and ensure timely resolution of audit findings through appropriate CAPA management and verification of effectiveness. Travel to clinical sites, vendors, and investigator meetings as needed.
• Inspection Readiness and Health Authority Support: Lead GCP inspection readiness activities across the organization, including development of inspection readiness plans, mock inspections, storyboards, SME preparation, document review, and inspection response coordination. Serve as the primary Clinical QA lead for FDA BIMO inspection readiness and support for other global regulatory inspections involving clinical trial activities. Partner with internal teams and external vendors to ensure inspection-facing documentation, processes, and responsibilities are inspection-ready at all times.
• Risk-Based Quality Management: Embed risk-based quality management principles into study oversight and clinical quality processes. Partner with Clinical Operations and cross-functional teams to support quality risk assessments, critical data/process identification, quality tolerance considerations where appropriate, and evaluation of key risk indicators and centralized quality signals. Ensure quality oversight activities are focused on matters most relevant to subject safety, rights, data integrity, and trial reliability.
• Inspection-Ready Documentation and TMF Support: Provide quality support and oversight related to Trial Master File (TMF) health, inspection-ready documentation practices, and completeness of essential records. Collaborate with study teams and vendors to ensure that documentation standards, reconciliation processes, and issue escalation practices support an inspection-ready state throughout study conduct.

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related discipline; advanced degree preferred.
• 10+ years of experience in Clinical QA/GCP Quality within biotechnology, pharmaceuticals, or a CRO environment.
• Strong knowledge of GCP and applicable global clinical regulatory requirements.
• Experience supporting quality oversight for Phase 1–3 clinical trials.
• Demonstrated experience with GCP audits, including investigator site and/or vendor audits.
• Experience supporting clinical deviations, investigations, CAPAs, and related quality system activities.
• Experience leading or supporting inspection readiness and regulatory inspections, including FDA BIMO inspections.
• Strong working knowledge of sponsor oversight expectations for CROs and other outsourced clinical vendors.
• Excellent judgment, communication, and collaboration skills, with the ability to influence across functions in a fast-paced environment.
• Willingness to travel as needed for audits, site visits, and inspection readiness activities (10-15%).

Preferred Qualifications:

• Experience as an early Clinical QA hire in a growing biotech company.
• Experience supporting biologics development programs.
• Familiarity with eQMS tools and clinical systems relevant to quality oversight.
• Experience with risk-based quality management and quality metrics.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates is $213,000 - $240,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

 Job Location:

• Remote; Waltham, MA candidates preferred

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

POSITION OVERVIEW:

Disc Medicine is seeking a highly skilled Corporate Accounting Manager to join its Finance organization and support the company’s financial reporting, control, and compliance requirements as a public, clinical stage biopharmaceutical company. Reporting to the Director of Accounting, this role will be responsible for leading critical components of the monthly, quarterly, and annual close processes; ensuring accurate and timely financial reporting in accordance with U.S. GAAP; and maintaining an effective internal control environment in compliance with Section 404(b) of the Sarbanes Oxley Act.

The Corporate Accounting Manager will oversee general ledger activities, including the preparation and review of complex journal entries, account reconciliations, and variance analyses, and will manage accrual processes across research, clinical operations, CMC, G&A, and commercial functions. This position will partner closely with FP&A and cross functional stakeholders to validate spend, support forecasting and budgeting activities, and develop and maintain clinical trial accrual models to ensure appropriate recognition of costs incurred.

In addition, the Corporate Accounting Manager will serve as a key liaison for internal and external auditors, supporting integrated audits and quarterly reviews through the execution, documentation, and testing of internal controls, as well as the preparation of audit schedules and supporting materials. The ideal candidate brings strong technical accounting knowledge, a disciplined approach to controls and compliance, and the ability to operate effectively in a fast paced, evolving public company environment while contributing to continuous improvement of accounting processes and systems.

RESPONSIBILITIES:

• Play a lead role in the monthly, quarterly, and annual close processes, ensuring timely and accurate financial reporting.
• Understands and applies U.S. GAAP, has strong internal control structure understanding and has willingness to challenge current processes or procedures as a trusted business partner.
• Prepares / reviews complex journal entries, account reconciliations, and variance analyses with a high degree of accuracy managing the monthly, quarterly, and year‑end close processes, ensuring timely and accurate financial reporting in accordance with US GAAP.
• Lead the monthly accrual process across research, clinical operations, CMC, G&A, and commercial functions, ensuring expense recognition reflects operational activity.
• Partner closely with FP&A, Clinical Operations, CMC, and other cross‑functional teams to validate spend and inform accrual estimates.
• Develop, maintain, and review clinical accrual models for multiple clinical programs across various phases, ensuring accurate recognition of costs incurred but not yet invoiced.
• Serve as a key point of contact for interim and year-end internal and external integrated audits, preparation of schedules, performance / documentation of controls and providing supporting documents.
• Analyze and explain variances between actual results, forecasts, and budgets to management and external auditors.
• Other duties as assigned.

 REQUIREMENTS:

• Bachelor’s degree in Accounting, Finance or related field
• 5+ years of progressive accounting experience, typically including a combination of public accounting and biotechnology or life sciences industry experience.
• Strong knowledge of US GAAP, Certified Public Accountant (CPA) is preferred
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
• Demonstrated ability to work in a dynamic and rapidly changing environment and the flexibility to handle multiple priorities simultaneously.
• Experience with ERP systems such as NetSuite and Coupa (preferred). Advanced Excel skills required.
• Minimum of 3 years of experience (either as an auditor or in industry) with internal controls under Section 404(b) of the Sarbanes-Oxley Act (SOX). Working knowledge of drug development process within the biotech/pharmaceutical industry, including clinical trial accruals is required.

Associate Director/Director, Scientific Communications, Cognito Therapeutics, Inc.

Location: Cambridge, MA, USA, Full-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

About the Job

The Associate Director/Director, Scientific Communications will play a pivotal role in shaping and executing an integrated scientific communications strategy to support Cognito’s pipeline and future commercialization efforts. Reporting to the Head of Medical Affairs, this individual will be a key member of the Medical Affairs team, responsible for leading medical education initiatives, publication strategy, and support of the Brain Health Collaboratories.

This role is central to translating complex preclinical, clinical, and real-world data into clear, accurate, and compliant communications for both internal and external stakeholders, including healthcare professionals, payers, and scientific communities. The Director will ensure timely and effective dissemination of scientific data while aligning communications with congress activities and subject matter expert (SME) engagement strategies.

The position may be remote or hybrid (Cambridge, MA) and requires both strategic leadership and hands-on execution in a fast-paced, innovative environment.

Roles and Responsibilities

Strategic Leadership & Planning

• Develop and execute an integrated scientific and medical communications strategy aligned with corporate objectives and evolving standards of care.
• Define and lead publication planning, including identification of key data milestones, communication opportunities, and stakeholder alignment.
• Ensure seamless integration of communication plans with congress strategy and SME/KOL development.

Scientific Communications & Content Development

• Translate complex scientific and clinical data into clear, compelling, and compliant communications for diverse audiences.
• Lead the development of medical communication materials, including:
• Abstracts, posters, manuscripts, and presentations
• Unbranded disease state education materials (e.g., slide decks, training tools)
• Support data dissemination across multiple platforms and audiences.

Omnichannel Execution

• Implement omnichannel communication strategies to ensure consistent, effective delivery across digital, print, and live channels.
• Support and participate in scientific congresses, including presentation of data as appropriate.

Cross-Functional Collaboration & Stakeholder Engagement

• Serve as a central point of contact for scientific communications, coordinating with internal teams, external partners, and publication authors.
• Build and maintain strong relationships with key opinion leaders (KOLs), investigators, and professional societies, particularly in Alzheimer’s disease and related neurodegenerative disorders.
• Support advisory boards, roundtables, and scientific exchange initiatives to capture external insights and inform strategy.

Training & Internal Enablement

• Develop and deliver medical and scientific training for internal stakeholders, including commercial, clinical, and cross-functional teams.
• Ensure alignment and scientific rigor across all internal education initiatives.

Governance, Compliance & Operations

• Lead Medical (MLR) review processes, along with Legal, and Regulatory partners to ensure all materials meet compliance and scientific accuracy standards.
• Manage external vendors and agency partners supporting medical communications.
• Ensure adherence to regulatory, ethical, and company standards across all activities.

Qualifications & Experience

• Advanced degree in a relevant scientific or clinical discipline (MD, PhD, PharmD, or equivalent) preferred.
• 5+ years of experience in Scientific or Medical Communications within biotech, biopharma, or medical device industries; experience in neuroscience or neurodegeneration strongly preferred.
• Demonstrated ability to translate complex scientific data into clear, impactful narratives.
• Proven success in KOL engagement, publication strategy, and medical communications execution.
• Experience collaborating across functions and managing external partners, including academic institutions and vendors.
• Strong leadership, communication, and organizational skills; ability to thrive in a fast-paced, matrixed, and entrepreneurial environment.
• Willingness to travel (~15–20%) for scientific congresses and internal meetings.

What You’ll Do:

The Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of commercial and clinical supply management and strategy, global regulatory requirements, and project management practices. The Director, Global Supply Chain partners with relevant internal functional groups to ensure uninterrupted supply of both Investigational Medicinal Product (IMP) for clinical studies as well as inventory of commercial drug products.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support commercial launch readiness, including vendor management, distribution planning, and leading the Supply and Operations Planning team
• Managing drug product supply and logistics activities including, but not limited to, demand forecasting and supply planning (clinical and commercial), IRT, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
• Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
• Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
• Providing day-to-day oversight of Packaging and Labeling/Distribution vendors, including relationship management
• Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
• Proactively identifying potential issues, notifying Management in a timely manner, and developing mitigating actions
• Coordinate the development of the commercial forecast
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts and develop supply plans
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
• Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
• Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
• Ensure temperature excursion processes are executed as required
• Guide the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
• Leverage inventory management capabilities of the IRT to appropriately manage clinical and commercial drug supply

Required Qualifications:

• Experience with global pharmaceutical development and manufacturing operations for development-stage and commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
• Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
• 8+ years of experience in clinical supply management
• Ability to cross-functionally communicate effectively with a high degree of emotional intelligence
• Deep understanding of IRT systems
• Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
• Strong computer skills including MS Office
• Hands-on, roll-up-your-sleeves, collaborative approach with a high sense of urgency and personal accountability to drive toward results
• Ability to think outside of the box and challenge the status quo
• Desire to work in a fast-paced, innovative environment
• Domestic or international travel is required (up to 20%)

Preferred Qualifications:

• Experience with pharmaceutical development and manufacturing operations for development-stage clinical products
• Experience with combination product device(s)

Education:

• Bachelor’s degree in pharmaceutical science, engineering, life sciences, or another relevant field. Advanced degree preferred

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.

We are looking for a Co-op, Analytical Development to join the Analytical Development team at Strand Therapeutics. The incoming co-op will work with the Analytical Development teams to help advance our analytical capabilities by executing on various experiments using techniques such as UPLC and LC/MS. The candidate will be expected to work in an innovative, fast-paced, and collaborative biotech environment.

Primary Responsibilities:

• Assisting in development and execution of chromatography-based mRNA/LNP analytical methods.
• Using various statistical tools to analyze and independently draw conclusions about data.
• Analytically supporting the screening, optimization, and scale-up efforts in mRNA and LNP Process Development.
• Working across diverse areas to support the group's development activities in a fast-paced and collaborative environment.

Qualifications:

• On track to graduate with a B.S. or M.S. in Biochemistry, Chemical Engineering, Molecular Biology, Bioengineering, Molecular Medicine, Genetics or related field. Experience in the biotechnology space is a plus.
• mRNA working experience is strongly preferred, but not a requirement.
• Basic knowledge of varying liquid chromatography modes such as RP, RP-IP, AEX, SEC etc. for biologics is desirable.
• Familiarity with process development, and/or regulatory aspects of mRNA/LNP products would be a plus.
• Ability to follow standard operating procedures, make careful observations, maintain clear and complete records of lab work.‪
• Strong collaboration and inter-personal skills. Ability to present scientific context, experimental set up, data interpretation, and big-picture conclusions to a diverse audience.

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates. 

Job Type: Co-op

Hourly Rate: $25 - $28 / hour 

ESSENTIAL JOB FUNCTIONS:

• Leads the planning and execution of a complex, global clinical trial from start-up through close-out, in compliance with regulations/SOPs, within budget and timelines.
• Provides oversight and guidance to clinical operations personnel assigned to the clinical trial.
• Partners closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
• Establishes strong relationships with investigators and KOLs.
• Contributes to the development and review of key study documents including protocols, ICFs, monitoring plans, EDC specifications and statistical analysis plans.
• Contributes to the selection of vendors and CROs. Manages and oversees CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
• Develops, manages, and tracks clinical trial budgets, ensuring studies are delivered within approved financial parameters.
• Provides regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
• Proactively identifies operational risks and implements mitigation strategies to maintain timelines, quality, and compliance.
• Supports and facilitates execution of contracts, clinical trial agreements, and study budgets.
• Direct manager of approximately 1-2 direct reports.
• Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• 10+ years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to travel domestically and internationally as required.
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Experience setting up clinical trials outside of US and Europe is a plus.
• Field monitoring and/or clinical data management experience preferred.
• Proficiency with Microsoft Project

The base range for a Director is $228,000 - $252,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

What You’ll Do:

We are seeking an experienced programmer to join us as Associate Director, Statistical Programming. This is a critical role responsible for leading statistical programming activities on the assigned disease area(s). This role will support clinical trials, regulatory submissions, and other key initiatives.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Lead statistical programming efforts for clinical studies, including the development and review of programming specifications to ensure clarity, integrity, and compliance with internal and external standards
• Lead the execution of ad-hoc and post-hoc analyses to support emerging clinical questions, publications, and internal decision-making
• Oversee and coordinate activities with Contract Research Organizations (CROs), focusing on the implementation of CDISC standards, creation of SDTM, ADaM datasets, and TFLs, and ensuring high-quality deliverables
• Conduct independent validation and quality checks of statistical programming deliverables from CROs
• Collaborate closely with statisticians and cross-functional study teams to deliver results in a timely and accurate manner
• Manage multiple projects simultaneously, ensuring tasks are prioritized effectively to meet deadlines

Required Qualifications:

• Proven hands-on experience in programming for clinical development, preferably in a leadership role, with a strong preference for late-phase clinical trial support
• Experience in regulatory submissions, including NDAs, BLAs, and other filings, with experience in ISS/ISE highly desirable
• Expertise in SAS programming and comprehensive knowledge of CDISC standards
• Familiarity with ICH/GCP guidelines and global regulatory submission requirements (e.g., FDA, EMA)
• Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables

Preferred Qualifications:

• Background in cardiometabolic diseases or related therapeutic areas is preferred

Education:

• Advanced degree (MS/PhD) in Biostatistics, Statistics, or a related field
• MS: Minimum of 8+ years of relevant experience
• PhD: Minimum of 6+ years of relevant experience

What You’ll Do:

The Senior Clinical Oversight Manager (COM) is responsible for executing the Clinical Monitoring Oversight visit process and Clinical Oversight Metrics. The Senior COM represents Kailera during Clinical Oversight visits and oversees study execution to ensure compliance with ICH GCP, and applicable regulations. The Senior COM is involved in planning, execution, and delivery of oversight processes including Standard Operating Procedures (SOP) and work instructions. 

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Develops the Clinical Monitoring Oversight strategy across studies, including development and oversight of Clinical Monitoring Oversight SOPs and templates, Clinical Oversight Monitoring plans, managing Monitoring Oversight Service Provider (SP) activities, providing study/program/SP level reporting, and leading monthly TMF health checks
• Evaluates and provides recommendations to the study team on Oversight Service Provider activities to ensure the appropriate scope of work, oversight, and training of clinical oversight CRAs to achieve study milestones within agreed upon timelines, budget and quality
• Assigns oversight visits at trial sites based on strategic criteria to evaluate compliance of trials with local regulatory requirements; overall data quality and integrity; and human subject protection
• Provides oversight on service provider execution of clinical trial activities in accordance with Kailera SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
• Develops key performance indicators (KPIs) and evaluates service provider operational data against KPIs to identify potential performance gaps
• Collaborates with the Clinical Oversight team, Clinical Quality Management, and Clinical Study Team to implement corrective actions and monitor progress through resolution
• Facilitate resolution of region specific and site management related challenges
• Acts on behalf of Business Operations on cross-functional project teams; interacts with internal and external groups
• Assist with creation and delivery of department initiatives, improvement plans, and/or training
• Selects and oversees Oversight CRAs globally, driving the team to ensure study deliverables are met with efficiency and quality in accordance with applicable SOPs, regulations, GCP, Key Performance Indicators (KPIs), and study-specific requirements
• Responsible for ensuring Oversight CRAs maintain their sites/studies as inspection ready, including the TMF, for health authority inspections
• Conduct periodic quality visits for Oversight CRAs, as needed
• Ensure the oversight CRAs are reviewing and ensuring data integrity, accuracy, and completeness at the clinical study sites
• Support and liaise with clinical site personnel, as needed
• Review contracts and approve vendor invoices

Qualifications:

• Minimum of 8+ years of clinical trial experience with strong knowledge of the clinical development process
• Experience with Phase I–III clinical trials, risk-based monitoring, and CRA Management
• Proficient in oversight tools and systems (CTMS, eTMF, dashboards, Microsoft Office)
• Experience with Vendor oversight, KPI tracking, and issue management
• Strong leadership, collaboration, and communication skills with the ability to manage and motivate team members (e.g., internal staff and external investigators/consultants)
• Excellent organizational, analytical, and interpersonal skills; able to work independently and in teams
• In-depth knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements
• Ability to manage complexity in a fast-paced environment
• Must have strong clinical study management, communication (oral and written), and analytical skills
• Must be able to travel

Education:

• Bachelor’s degree in a scientific or healthcare-related field

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Purpose/Summary:

This position is responsible for all aspects of Chemistry, Manufacturing, and Controls (CMC) drug product development from early stage to late-stage clinical development and commercialization, including development of efficient and scalable manufacturing processes, technology transfer, manufacturing of clinical supplies, and management of supply chain for clinical supplies. She/he is also responsible for preparation and review of all CMC regulatory filings. 

At this stage, the primary activities are focused on supporting Phase 3 clinical trials, including manufacturing clinical supplies, managing resupply needs, and overseeing the clinical trial supply chain and drug/device combination product interface.

The Head of Drug Product Development leads activities of an internal multifunctional team and network of external Contract Development and Manufacturing Organization (CDMO) partners working on all aspects of CMC development.  Functional responsibilities as project leader include formulation and manufacturing process development, oversight of drug product development, technology transfer and scale-up, and oversight of packaging and labeling, clinical supply chain, and CMC project management for drug product and drug/device combination product interface related activities.  Must possess strong leadership experience including strong CMC expertise and good technical understanding of the inter-disciplinary nature of drug development demonstrated by previous experience with injectables and drug/device combination products. She/he will collaborate closely with cross-functional internal and primarily external (CDMOs) team members in CMC development, Regulatory, Quality, Clinical Operations and Development during all phases of product development Ph 1- Ph 3, technology transfer, validation, manufacturing and filing IND, IMPD, NDA, MAA registration.

Essential Functions:

• Lead internal and CDMO Drug Product teams and represent Drug Product Development in multidisciplinary project teams as a project leader, work collaboratively to ensure project progression, and communicate Tech Ops strategy and related challenges.
• Encourage innovative, cross-functional thinking, and engagement of outside expertise as appropriate to help further Tech Ops/Corporate goals
• Ensure robust planning and execution of product development efforts across Ironwood's portfolio of development candidates from IND, Ph1, Ph2, Ph3 to commercialization. Proactively identify and mitigate risks to advance products in a timely manner.
• Ensure effective communication with key partners internally (particularly program management, regulatory, clinical development, and quality) and with an external CDMO network.
• Set Drug Product team budget and have financial accountability for drug product development activities per the annual operating plan.
• Responsible for Drug Product CDMOs timelines and Drug Product functional planning by providing technical oversight to ensure that Ironwood’s development and clinical manufacturing needs are met.
• Provide oversight to the clinical trial supplies team managing the inventory/delivery of Investigational products.
• Apply formulation and manufacturing principles, theories, and techniques to product development, and ensure development of the best possible phase-appropriate formulations.
• Supervise Drug Product and Clinical trial Supply scientists internally and externally to deliver on chemical, formulation, and analytical drug product development goals.
• Enable risk-based and compliant development practices: Identify and evaluate risks and provide recommendations to close via internal or external collaborations. Ensure development activities are documented per Ironwood documentation policies and underlying data are traceable.
• Author and/or review technical reports and relevant CMC sections for regulatory submissions (INDs, IMPDs, NDAs, etc.). Accountable for content development of FDA and exUS regulatory filings in collaboration with Regulatory, Quality, Supply Chain and members of the Development teams.

Requirements:

• PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry, or related scientific field with at least 15 years of industrial experience with at least 10 years of senior leadership experience in leading CMC/formulation teams especially in the injectable space (more specifically vials, both liquid and lyophilized drug products).
• Experience with injectable drug products containing synthetic peptides.
• Experience with leading drug product teams for injectable products during Phase 3, process validation, launch readiness and transition to commercial production.
• Experience with early phase development (pre-clinical, and Phase 1) a plus.
• Demonstrated experience supporting drug–device combination product development, with specific expertise in fill‑finish processes (e.g., prefilled syringe, autoinjector, dual-chamber cartridge) and conducting drug product–device / container compatibility evaluations.
• Experience with clinical studies and supply chain management oversight a plus.
• Comprehensive understanding of all aspects of CMC including process and formulation development, analytical science, regulatory, and quality.
• Strong group leadership, communication, and collaborative skills (both cross-department and with development partners). Experience working with global teams is strongly desired 
• Experience in managing development and manufacturing activities at global CDMOs
• Experience with synthetic peptide manufacturing processes, injectable drug product manufacturing, and finished goods primary packaging 
• Working knowledge of approaches for characterization of solution and solid-state properties of materials, and technologies for delivery of synthetic peptides
• Excellent data analysis skills and the ability to make recommendations that impact the scientific and business goals of the company. Ability to articulate complex issues and ideas with clarity to enable understanding and direction.
• Solid understanding of ICH, FDA, EMEA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of product development
• Strong understanding of drug–device combination product development, including primary container interactions, fill‑finish considerations, and drug product–device compatibility
• Experience with submissions and interactions with regulatory agencies regarding CMC issues during product development and primary container/packaging for drug-device combination products. Thorough knowledge of INDs, IMPDs, MAAs, NDAs, etc.
• The ability to work successfully in both a team/matrix environment as well as independently is required
• The ability to influence cross-functionally to enable development improvements and team performance.
• Good communication, project management, and interpersonal skills
• Effective and innovative problem-solving skills

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

Ironwood currently anticipates that the initial base salary for this position could range from between $246,000 to $286,650.  The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

What You’ll Do:

The Director, Clinical Scientist is a senior, hands-on scientific leader responsible for the scientific execution of clinical trials. This role partners closely with Clinical Operations and cross-functional teams to ensure high-quality trial conduct, rigorous data review, and clear scientific communication from study start-up through reporting.

This position requires deep clinical trial experience, strong organizational skills, and comfort working directly in trial data. An MD is not required for this role.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support the Medical lead for one or more Phase I–III clinical studies
• Support studies across the full trial lifecycle, from start-up through database lock and reporting
• Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs
• Identify data trends, inconsistencies, and potential issues; partner with Data Management, Biostatistics, and Safety to resolve them
• Act as a close scientific partner to Clinical Operations to deliver on trial execution
• Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
• Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
• Develop and deliver clear, well-structured presentations to study teams and internal leadership
• Drive execution, follow-through, and accountability across multiple concurrent deliverables
• Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s

Required Qualifications:

• 8+ years of extensive hands-on experience supporting clinical trials in a clinical development role
• Demonstrated experience reviewing and interpreting clinical trial data listings
• Strong understanding of clinical trial conduct and cross-functional trial workflows
• Proven ability to partner effectively with Clinical Operations
• Exceptional organizational, prioritization, and execution skills
• Strong written and verbal communication skills
• Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
• Ability to manage multiple studies and deadlines in a fast-paced environment

Education:

• Advanced degree in life sciences discipline (PhD, PharmD, MS, or equivalent)

What You’ll Do:

We are seeking an experienced, highly motivated Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Responsible for medical monitoring/reporting and safety activities
• Provide medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
• Acts as the medical contact at the company for clinical/medical issues
• Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
• Serve as the medical expert for assigned assets studies
• Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
• Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
• Oversee and support data interpretation, analysis, and clinical study reports
• Work closely with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams
• Partner with external collaborators, KOLs, CROs, and investigators
• Support scientific publications, conference presentations, and other external communications
• Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting

Required Qualifications:

• 3+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
• Hands-on experience designing and executing clinical trials
• Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
• Excellent written and verbal communication skills, including protocol and regulatory document writing
• Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
• Can work independently, self-starter attitude
• Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
• Ability to manage multiple studies and deadlines in a fast-paced environment
• Must be exceptionally detail oriented

Preferred Qualifications:

• Experience in cardiometabolic therapeutic area is advantageous
• Proven track record of contributing to IND submissions and global regulatory filings is a strong plus

Education:

• MD or equivalent is required

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established three platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work in a matrix-based environment and be a part of the future strategy of the company.

We are looking for a highly motivated and innovative candidate for the role of Associate Scientist II / Senior Associate Scientist of Nanoparticle Process Development. This individual will support in production and scale up of LNPs with nucleic acid payload. Reporting to the Principal Scientist of Nanoparticle Process Development, the right candidate will be a strategic thinker that brings a leadership presence and enthusiasm for Strand along with deep scientific knowledge.

Primary Responsibilities:

• Execute experiments related to LNP mixing and downstream purification/filtration to improve the process.
• Contribute to development of a robust formulation process with emphasis on scale-up, tech-transfer and stability.
• Contribute to thorough characterization of LNPs by existing methods and collaborating with internal stakeholders on developing new methods.
• Coordination with other team members to support the group's research activities in a fast-paced and collaborative environment.

Qualifications:

• B.S. with at least 2-5+ years of relevant experience or M.S. with at least 1-3+ year of relevant experience with an educational focus in Chemical Engineering, Bioengineering or similar preferred.
• Experience with LNPs required and nucleic acid payloads required.
• Experience with TFF required with emphasis on LNPs highly preferred for Associate Scientist II level, required for Senior Associate Scientist level.
• Experience with QbD principles, scale up efforts and JMP DOE is a plus.
• Experience with various mixing geometries as well large scale LNP production preferred for Associate Scientist II level, required for Senior Associate Scientist level.
• Strong collaboration and inter-personal skills.
• Ability to multi-task and prioritize to meet important deadlines.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $84,000 - $100,000 annually plus bonus and equity incentives

Principal Software Developer, Cognito Therapeutics, Inc.

Location: Cambridge, MA, USA, Full-time

Company Description

Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX, IAG, Starbloom) late clinical stage company translating scientific findings from MIT into therapeutic approaches for brain health, including Alzheimer’s disease and other neurodegenerative conditions. We were awarded a Breakthrough designation by the FDA in December 2020 based upon our feasibility data that showed our therapy’s strong safety profile and a notable preservation of cognition and function in patients with mild-to-moderate Alzheimer’s. We completed enrollment in our pivotal study, HOPE, in June 2025 and expect to release topline data from the trial in summer 2026. We are a fast-moving, highly motivated team of innovators with the ambitious goal of helping millions of patients and caregivers around the world who are impacted by neurodegenerative conditions. With our patented brain stimulation technology, we are committed to developing convenient, safe and effective neuroprotective therapies to improve brain health and well-being for all.

About the Job

We are seeking a talented and motivated Principal Software Developer to join our dynamic and innovative team. As a Principal Software Developer, you will take the lead in designing, developing, and maintaining high-quality software solutions that meet our product and business needs.  You will collaborate closely with cross-functional teams, including product managers, designers, and quality assurance professionals, to deliver exceptional software products that drive our business forward.  You’ll take ownership of software projects in critical areas. As the company expands you will lead and guide peers and junior technical staff in your area(s) of expertise. 

Roles & Responsibilities:

• Develop high-quality software solutions: Design, code, test, and debug software applications using programming languages and frameworks such as Java, C, C++, Python, or JavaScript, ensuring adherence to coding standards and best practices.
• Collaborate with cross-functional teams: Work closely with product managers, designers, and other stakeholders to understand requirements, provide technical insights, and contribute to the overall product vision.
• Lead through the full software development life cycle: Contribute to all phases of the software development process, including requirements gathering, design, implementation, testing, deployment, and maintenance.
• Perform code reviews and ensure software quality: Review code written by team members, provide constructive feedback, and conduct thorough testing to identify and fix bugs, ensuring software quality and reliability.
• Stay up-to-date with industry trends: Continuously learn and stay current with the latest tools, technologies, and programming languages relevant to software development, and propose innovative solutions to enhance our software products.
• Troubleshoot and resolve technical issues: Investigate and address software defects, performance bottlenecks, and other technical issues, collaborating with the team to find effective solutions.
• Collaborate in an Agile environment: Run Agile ceremonies, such as sprint planning, daily stand-ups, and retrospectives, fostering a collaborative and iterative approach to software development.
• Lead Projects: Manage small technical teams, and interface with peers and superiors to reach outcomes important to the company.
• Mentor Junior Staff: Provide technical and career guidance to more junior software staff, fostering an environment of collaboration, technical excellence and growth.
• Document and Communicate: Create and maintain technical documentation, including design specifications, user manuals, and API documentation, and effectively communicate complex technical concepts to both technical and non-technical stakeholders. 

Who You Are 

Join our team as a Principal Software Developer and contribute to the development of innovative software solutions that drive our organization's success. Together, we can make a meaningful impact and create exceptional software products that exceed our customers' expectations.

Minimal Qualifications

• Bachelor's degree in Computer Science, Software Engineering, or a related field. Equivalent work experience may be considered.
• 8+ years of Software Development experience
• Demonstrated experience leading complex technical projects or systems, with expertise in one or more programming languages and frameworks.
• Strong problem-solving skills and ability to analyze complex problems, propose creative solutions, and implement them effectively.
• Solid understanding of software development principles, practices, and methodologies, including Agile/Scrum.
• Familiarity with version control systems (e.g., Git), software testing, and debugging tools.
• Excellent teamwork and communication skills, with the ability to collaborate effectively with cross-functional teams and articulate technical concepts to non-technical stakeholders.
• Experience leading small technical teams, where you remain a highly engaged individual contributor.
• Strong attention to detail and a commitment to delivering high-quality software solutions. Strong technical opinions driven by experience and expertise.
• Continuous learning mindset and a passion for staying up-to-date with emerging technologies and industry trends.
• Software Development Life Cycle experience is a plus
• Medical Device Experience is a plus
• Programming with mobile applications is a plus
• Embedded device experience is a plus
• FDA Cybersecurity compliance experience is a plus
• Cloud application development is a plus
• Leading a team of software developers.

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking to build a team that understands the value of working at a start-up.  Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team.  This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.

Strand is seeking a Director of Contracts to partner closely with the COO and Executive Leadership Team to lead the company’s contracting function, including risk governance, negotiation oversight, and continuous improvement of legal operations. As a clinical stage biotechnology company with a Phase 1 oncology asset and additional programs advancing into the clinic, Strand requires a contracting leader who can operate with a high degree of autonomy, sound judgment, and strategic insight.

This is an individual contributor role within a lean legal team reporting directly to the COO. The Director of Contracts will independently lead a high volume of complex biotech agreements annually, ensuring alignment with company risk tolerance while enabling business, scientific, and clinical objectives.

Primary Responsibilities:

• Lead drafting, review, redlining, and negotiation of complex biotech agreements, including master service agreements and related statements of work/work orders, material transfer agreements, clinical trial agreements, CRO and vendor agreements, consultant agreements, confidentiality agreements, and IP-sensitive contracts.
• Translate scientific, clinical, operational, and financial objectives into clear contractual protections that align with Strand’s risk framework.
• Apply knowledge of FDA-regulated environments and GxP standards to support contracting for clinical programs and pipeline expansion.
• Partner cross-functionally with Clinical, Research, CMC/Tech Operations, Finance, and executive leadership to understand the underlying business need giving rise to each contract and incorporate that context into negotiations.
• Determine when engagement of external counsel is appropriate and effectively manage outside counsel by providing strategic direction, evaluating redlines, and ensuring alignment with company risk tolerance and cost efficiency.
• Contribute to the development and refinement of internal contracting policies, playbooks, and process improvements to enhance efficiency, consistency, and compliance.
• Provide regular visibility to the COO and leadership team on contract status, risk considerations, and negotiation strategy. Proactively escalate high risk items within individual contracts as needed. 
• Support legal diligence efforts in connection with financings and other corporate transactions.

Qualifications:

• J.D. with significant experience (6+ years preferred) reviewing, redlining, and negotiating biotech or pharmaceutical contracts, including clinical-stage agreements required.
• Demonstrated experience with CRO and clinical vendor contracting in FDA-regulated, GxP-compliant environments.
• Strong familiarity with IP-sensitive agreements and risk allocation in research and development settings.
• Experience managing and directing external counsel under an appropriate risk framework.
• Strong interpersonal skills with the ability to understand scientific, clinical, and business needs and communicate contractual tradeoffs effectively to executive leadership.
• Ability to work across all levels of the organization; and partner closely with the internal legal team.
• Exceptional organizational and time management skills with the ability to manage a substantial and dynamic contracting workload.

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $205,000 - $240,000 annually plus bonus and equity incentives

Company Overview:

Strand Therapeutics is a clinical stage biotechnology company utilizing synthetic biology to genetically program mRNA to deliver truly revolutionary immunotherapies to patients.

Building on the idea of creating smart therapies based on Boolean logic circuits, Strand was started by biological engineers working together at MIT who were seeking to apply the concept of the emerging field of mRNA therapeutics. Strand's technology is therapeutic-area and mRNA modality agnostic where therapeutic proteins are encoded onto modified, self-replicating, or circular mRNA backbones which in turn are programmed with cell-specific sensors and circuits.

Today, Strand has established multiple programmable mRNA platforms with one clinical stage asset and several programs in preclinical development as well as early discovery. Our lead program, STX-001, is currently being evaluated in a Phase 1 clinical trial for solid tumors. Our corporate headquarters is located in the Fenway district of Boston, Massachusetts.

Become the next standout single strand!

Job Summary:

Strand is looking to build a team that understands the value of working at a start-up.  Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team.  This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.

We are looking for a highly motivated and enthusiastic leader for the role of Vice President of Clinical Development Operations. Reporting to the Chief Medical Officer, the Vice President of Clinical Development Operations will lead all clinical trial activities and operations for the organization. This individual will drive all trial activities for our 2 clinical stage programs as well as support the planning and development of other company programs as they advance throughout pre-clinical development into first-in-human clinical trials. This will also be an opportunity to work closely with various cross functional teams internally and externally to prepare for regulatory interactions and drive the development of our programs forward. 

Primary Responsibilities:

• Serve as the clinical operations expert for all clinical stage and preclinical stage programs for the company. 
• Accountable for delivery of assigned clinical program/trial budgets, managing study timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan
• Develop clinical timelines, budget forecasts and ensure accountability for tracking and deliverables.
• Develop and maintain departmental resource and budget plans.
• Ensures oversight and study-specific Risk Management Plans (RMP) (e.g., milestones, metrics, and critical path), ensuring appropriate escalation when required. Evaluate study-level issues for broader impact (e.g., cross-study, cross-program etc.) and ensure resolution
• Partner and collaborate with cross-functional stakeholders, external consultants, and other relevant stakeholders
• Lead and oversee execution of clinical trials in compliance with ICH/GCP, local regulations, and Strand Therapeutics’ SOPs to ensure quality and data integrity
• Support the selection, oversight, and management of CROs and other vendors including financial aspects of the partnerships.
• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team.
• Develops site recruitment, enrollment, and engagement strategies for all clinical trials
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
• Manage and provide oversight to the cross functional teams and CRO/vendor(s) related to all aspects of clinical trial operations
• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures. Manages content, agenda, and discussions at clinical operations sub-teams and ensures action items are closed
• Along with other Clinical Development personnel, represent Strand Therapeutics externally to Investigators, site staff, and Key Opinion Leaders
• Perform and document study level Sponsor Oversight of outsourced clinical activities
• Communicate study-status, cost, and issues to ensure timely decision-making by senior management
• Oversee/collaborate with Clinical Quality Assurance on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance
• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives
• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Strand Therapeutics
• Provide oversight and mentorship to assigned Clinical Operations staff by providing clinical operations/functional area expertise and support identification and prioritization of study and program level work. Will have direct line management of Clinical Operations staff.
• Strive for continuous improvement and more efficient ways of working in clinical operations
• Supervise Clinical Operations Team (CTMs, CRAs, CTAs, etc.) and ensure team member’s adherence to the regulatory requirements, ICH-GCP guidelines, and other relevant procedures.
• Participate in the design, development and review of clinical trial protocols and study-specific documents, e.g., informed consent forms, study guidelines, operations manuals, oversight plans, process developments (including Trial RACI).
• Keep up to date with industry practice and communicate key messages back to Strand Therapeutics, providing recommendation accordingly.

Qualifications:

• 15+ years of clinical trial operations experience in biotech; Experience working in a smaller, fast paced environment highly preferred with 5+ in management or leadership roles.
• Experience running oncology trials required.
• Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential.
• Experience with all aspects of clinical trial management including streamlining operational activities of trial protocols and ensuring deliverables are attained in a timely manner. 
• Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include executive leadership, regulatory, QA, CMC, translational development, program management, finance, business development, medical affairs and medical writing).
• Extensive experience with the identification, negotiation, management, and oversight of external vendor partnerships, such as CROs, for monitoring, database management, statistics, and safety reporting. 
• Experience building an internal clinical program management function, managing a team of employees and consultants as well as hiring internal stakeholders to support trial needs and leveraging external consultants as needed. 
• Experience with regulatory submissions, including INDs, NDAs and BLAs highly preferred. 
• Experience interacting with domestic health authorities, such as the FDA, required; Experience interacting with global regulatory health authorities, such as the EMA, PMDA, and/or Australian CTN is a plus. 
• Strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization. 
• Strong organizational and time management skills. 

Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand’s goals. 

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

Job Type: Full-time

Salary: $316,000 - $356,000 annually plus bonus and equity incentives 

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure, as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. 

Purpose / Summary:

Reporting to the Head of Regulatory Affairs CMC, the Director, Global Regulatory Affairs – CMC is responsible for owning and leading the global CMC regulatory strategy and execution to enable clinical development, commercialization, and lifecycle management of the company’s products. This individual ensures that global CMC regulatory requirements are proactively identified, strategically addressed, and fully integrated into development and commercial plans.

The Director serves as the single-point CMC regulatory lead for assigned programs, accountable for regulatory strategy, health authority engagement, submission quality, and inspection readiness. This role requires close collaboration with senior leadership and cross-functional stakeholders to define regulatory objectives, manage risk, and support timely, high-quality global submissions and approvals.

Essential Functions:

• Lead and own the global CMC regulatory strategy for assigned programs across development, registration, and lifecycle management, identifying key risks, remediation activities, and opportunities for acceleration while ensuring approvability and inspection readiness.
• Serve as the regulatory CMC representative on internal CMC teams, core submission teams, and cross-functional governance forums, providing authoritative regulatory input and decision-making support.
• Provide strategic global Regulatory Affairs–CMC guidance to project teams and ensure timely development and execution of integrated regulatory project plans.
• Assess, interpret, and communicate global CMC regulatory requirements to ensure all development and commercial activities comply with applicable regulations, guidelines, and regional expectations.
• Initiate, lead, and strategically manage interactions with global health authorities (FDA, EMA, PMDA, and other national competent authorities) to obtain alignment on CMC strategy, negotiate data requirements, resolve issues, and support timely approvals.
• Lead preparation of high-quality CMC briefing packages and regulatory narratives for health authority meetings, including definition of regulatory positions, risk mitigation strategies, and alignment of supporting data; participate in or lead agency interactions as a key spokesperson.
• Provide strategic regulatory leadership for GMP inspections and PAI readiness, including inspection preparation, response strategy, and alignment of regulatory commitments with Quality and Tech Ops execution.
• Coordinate, review, and be accountable for the quality and timeliness of global CMC regulatory submissions and lifecycle filings, including original INDs, CMC amendments, IMPD amendments, annual reports, meeting requests, briefing packages, marketing applications, and post-approval changes.
• Work directly with external contractors and collaborators, managing regulatory deliverables, communication pathways, and project plans to ensure accuracy, compliance, and executional success.
• Establish and lead CMC regulatory governance for assigned programs, including defining review cadence, risk escalation pathways, and communication of status, risks, and decisions to senior leadership and executive management.
• Remain current on evolving global regulations, standards, policies, and guidance issued by relevant regulatory authorities and assess impact to development and commercial programs.
• Partner with cross-functional stakeholders to proactively identify, escalate, and resolve CMC regulatory issues impacting development timelines or approval readiness.

Requirements:

• Bachelor’s degree in a scientific discipline such as Biology, Chemistry, or Pharmaceutical Sciences; advanced degree preferred.
• Minimum of 10 years of progressively increasing responsibility in CMC Regulatory Affairs within the biopharmaceutical industry.
• Demonstrated experience leading successful global marketing application submissions and approvals.
• Proven experience preparing CMC sections of global clinical trial applications (IND, IMPD, CTA).
• Experience with drug-device combination products preferred.
• Demonstrated ability to develop and defend CMC regulatory strategies supporting new product development, commercialization, and lifecycle management.
• Strong track record of successful global regulatory interactions and submissions for biologics, innovative medicines, and/or combination products in the US, EU, and other regions.
• Demonstrated ability to provide risk-based regulatory decision-making and strategic recommendations to senior leadership.
• Strong leadership, communication, and interpersonal skills with the ability to influence decision-making diplomatically across functions.
• Ability to work independently and effectively within matrixed, cross-functional teams and with external partners.
• Excellent written and verbal communication, organizational, and project management skills.
• Ability to operate in a fast-paced environment while managing multiple priorities.

Ironwood 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, disability, or protected veteran status.

Ironwood currently anticipates that the initial base salary for this position could range from between $208,000K - $243,600K. The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.

#LI-Hybrid

The Vascular Care Group (TVCG) seeks a BC/BE Vascular Surgeon to join our practice. This position is located in our Hyannis, MA office with a satellite location in North Falmouth, MA.

About Us:

The Vascular Care Group is the largest and fastest growing privately owned and operated vascular surgery group in the United States focused primarily in the greater New England area. The group is uniquely positioned to offer cutting-edge, comprehensive vascular and endovascular services in both our office-based lab and various inpatient settings with expanding partnerships with some of the largest healthcare systems and most prestigious academic centers in the country.

As part of the group, you will practice alongside some of the most experienced and renowned surgeons who have been at the forefront of advancing vascular surgical care and have been recognized for medical excellence by their peers. The Vascular Care Group is uniquely positioned to participate in and lead multiple clinical trials across various disease processes given the unique capabilities of its partnership and collaborations with the renowned clinical trials platform, Vascular Breakthroughs. The group currently participates in more than 20 clinical trials and is the top enroller in many of these clinical trials including industry sponsored and physician lead investigational device exemption trials and first-in-man treatments. Other highlights of joining this group includes, but are not limited to:

• Private practice group with strong hospital alignment.
• Excellent support, mentorship, and quality of life with a favorable call schedule.
• Partnership track offering competitive salary and benefits.
• Brand new, state-of-the-art office equipped with outpatient interventional capabilities, non-invasive vascular lab, and vein center.
• The opportunity to quickly advance towards partnership and leadership roles.
• Opportunities of implantation of innovative thoughts and ideas with resources to implement these clinically with the proper research and scholarly processes.
• Access to comprehensive and high-level patient databases with ample opportunities for publications, podium and panel presentations, as well as national and international prominence alongside academically renowned surgeons.

The Hyannis Practice:

• An hour outside of Boston.
• Mentoring from three experienced vascular surgeons recognized for clinical and teaching excellence.
• We currently perform the full spectrum of peripheral arterial, mesenteric, renal, embolization, deep venous and central venous interventions in our state-of-the-art office based facility.
• Dedicated and experienced office based interventional, clinic and vascular laboratory staff to optimize your efficiency.
• The ability to perform open and endovascular surgery cases at Cape Cod Hospital.
• Access to over 20 cutting edge clinical trials and new devices through our own clinical trials platform.
• The opportunity to start in an established vascular practice and be immediately busy with clinic patients and a wide range of endovascular and open operative procedures.

Benefits of Practicing at The Vascular Care Group include:

• Strong, collaborative physician community.
• Collaboration and sharing of best practices through practice-wide regular case conferences and a HIPAA-compliant communication platform.
• Quality assurance (QA) and clinical pathways.
• Opportunities for cross-functional work and collaboration with other clinical areas.
• Established patient referral network.
• Access to advanced data analytics for optimizing patient care.
• Robust support for practice management, staff recruitment and retention, billing and coding, equipment and supply purchasing, marketing, and public relations.
• Organization built on collaborative practices and community.
• The opportunity to attend and present at clinical trial investigator meetings along with regional and national vascular meetings.

Join one of New England’s fastest-growing surgical teams at our dynamic Hyannis, MA practice. Cape Cod offers an exceptional quality of life, blending coastal charm with a vibrant, family-friendly community. Residents enjoy sailing, boating, beaches, bike trails, and outdoor recreation, along with excellent dining, local arts, and year-round community events. Hyannis serves as the hub of the Cape, providing convenient access to shopping, restaurants, and ferries to Martha's Vineyard and Nantucket. With strong schools, safe neighborhoods, short commutes, and easy access to Boston, Cape Cod is an ideal place to build both a rewarding career and a fulfilling life. 

The ideal candidate would possess the enthusiasm and drive for a robust clinical practice and desire for enhancement, advancement, and improvement of the quality of minimally invasive care across any and all aspects of vascular and endovascular surgery.

Interested applicants seeking consideration can email a Letter of Interest with CV to:

Carley Buckley, Physician Recruiter
The Vascular Care Group
CBuckley@mangrovemp.com
www.mangrovemp.com | www.thevascularcaregroup.com

The Vascular Care Group is an equal opportunity employer that values diversity and provides a supportive environment for employees of all backgrounds, cultures, ages, lifestyles, and abilities.