Lead Validation Engineer Responsibilities:

• Lead second shift CQV execution activities across multiple systems and workstreams
• Coordinate daily execution priorities to recover schedule slippage and maintain timelines
• Interface with QA, Engineering, and Operations to resolve issues in real time
• Oversee execution of IQ/OQ protocols and operational verification activities
• Support and review: 
  • Drawing walkdowns
  • Equipment and component verification
  • Materials of Construction (MOC) and weld verification
• Provide oversight for temperature mapping and validation activities
• Support SIP/CIP and related cycle development activities as needed
• Ensure all documentation meets GMP/GDP and audit-ready standards
• Drive deviation identification, escalation, and resolution

Job Requirements:

• Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 8+ years of CQV/validation experience in pharma or biotech
• Strong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)
• Proven experience leading validation teams or shift-based execution efforts
• Strong GMP/GDP knowledge
• Experience with eVal (required), ValGenesis a plus
• Experience with temperature mapping (Ellab a plus)
• This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekends

This role requires the ability to be on-site, full-time in Devens, MA.

Position Description

The Director, Regulatory Labeling, Advertising & Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.

The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.

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

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.

Advertising and Promotion

• Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends
• Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.
• Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.
• Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
• Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

• Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.

Cross-Functional Leadership

• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Essential/Required Qualifications:

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance
• Experience with MLR review and developing Company Core Data Sheets
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgement and risk-based decision making.
• Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.

Key Competencies:

• Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.

What You’ll Do:

The Senior Specialist, GMP Quality Assurance will collaborate internally with QA, RA, and CMC departments. As needed, work with external Approved Service Providers to ensure oversight and compliance. The Senior Specialist will perform review of drug substance/drug product manufacturing records and associated documents (i.e. deviations) for product that will be released for use in Kailera phase I-III clinical programs. The Senior Specialist will help continuously improve Quality System Procedures related to GMP activities related to their function and will collaborate closely with internal cross-functional teams.

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

Responsibilities:

• Review and approve Service Provider GMP documentation
• Review and approve master batch/packaging records
• Review executed batch/packaging records for Intermediates, Drug Substance, and Drug Product
• Prepare batch file for final batch disposition for Kailera’s Phase I-III clinical programs
• Review GMP Quality Events, change controls, CAPA’s, and other GMP documentation as needed
• Identify and escalate issues effectively
• Compile data for Quality System Reviews
• Evaluate GMP activities for continuous improvement opportunities
• Support creation and continuous improvement of Kailera procedures
• Other Quality Assurance responsibilities as assigned

Required Qualifications:

• 6+ years of experience in an FDA regulated Pharmaceutical Industry with GMP experience
• Understanding and knowledge of industry standards, concepts, current cGMP (21 CFR Parts 210 & 211 & Part 11 and EudraLex), and other agency standards and guidance as they relate to quality systems/quality assurance
• Experience with review of GMP manufacturing/packing records (Master/Executed Batch Records, Deviations, Change Controls, etc.) associated with Phase I-III clinical studies
• Proficient in Veeva QualityDocs and Veeva QMS a plus
• Demonstrates proven track record of communication with internal and external Service providers
• Ability to identify quality issues requiring escalation
• Clear, concise writing skills and good verbal presentation skills
• Self-motivated, detail oriented, well organized, and able to manage multiple projects
• Ability to interact constructively and efficiently with co-workers within and across departments and Management, as well as with Service providers in a professional and collaborative manner

Preferred Qualifications:

• Biotech experience preferred

Education:

• BA or BS degree in a scientific discipline or supplemental Quality education

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

POSITION OVERVIEW:

As Disc Medicine transitions from a clinical-stage organization to a commercial-stage one, the company is introducing a new role: Director of Clinical Quality Control. The successful candidate will play a crucial role in driving the company’s growth and achieving strategic objectives.

The Director of Quality Control will manage stability studies for various small-molecule and biologics programs in clinical development, ensuring compliance with ICH and GMP guidelines. The primary functions include protocol design; coordination and execution of various stability studies at CDMOs; statistical analysis; and expiration dating.  Additionally, this role will oversee the end-to-end supply of reference standards for quality control testing, including sourcing/production, qualification, inventory and distribution, as well as lifecycle monitoring. Significant contributions from this role will be essential for facilitating regulatory filings of Disc Medicine assets.

This position reports to the Head of Analytical Development and Clinical Quality Control within the Technical Operations organization at Disc Medicine. The ideal candidate should have at least 10 years of experience in quality control management in the pharmaceutical or biotech industry.

RESPONSIBILITIES:

This role will have extensive technical expertise and be responsible for stability and reference standard management for Disc Medicine’s clinical development programs. The technical responsibilities include:

• Evaluate, select, and manage CDMOs for QC stability testing.
• Direct stability studies per ICH guidance, sample pulls, and data analysis to determine retest periods and product shelf-life.
• Create, revise, and approve SOPs, stability protocols, and reports in accordance with current GMP, ICH, and global regulatory guidelines.
• Create, implement, and manage stability databases, forecast stability testing, and report on metrics, perform data trending and statistical analysis to support expiry dating. 
• Manage Quality System records for QC Stability: create, assess, review Deviations, Change Controls, CAPAs, and other applicable stability-related investigations and events
• Oversee the sourcing, characterization, qualification, retesting, and inventory management of primary and working reference standards.
• Author and review the stability and reference standard sessions of the global health authority dossier for clinical trials and commercial licensure.
• Support GMP audits and inspections.
• Act as the team leader to ensure alignment and effective communication among cross-functional areas, including analytical development, process development, formulation development, manufacturing, supply chain, regulatory, quality assurance, and other internal and external partners.
• Design and improve processes to ensure compliance with global regulatory requirements.
• Establish and maintain a network of external partners to fulfill technical and capacity requirements.
• Support the budget planning and resource allocation to support laboratory operations and staffing.

 REQUIREMENTS:

• A B.S. degree is required; an advanced degree (e.g., M.S./Ph.D.) in a related field is preferred.
• At least 10 years of experience in the biopharmaceutical industry, including prior leadership experience in quality control functions.
• Knowledge of product stability, setting of specifications, product shelf-life management, and experience with QC OOS investigations.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with Veeva, LIMS and Smartsheet desirable.
• Knowledge of bioanalytical and analytical methods, including but not limited to LC-MS, GC-MS, UV-vis, IR/FT-IR, HPLC (SEC, icIEF), CE-SDS, ELISA, cell-based potency assays.
• Experience with method validation, method transfer, and hands-on management of day-to-day testing operations for outsourced small molecules and biologics therapeutics.
• Working knowledge of quality systems, global regulatory requirements (example: 21 CRF Part 11/210/211,820), and Guidance documents.
• Knowledge of technical writing for CMC sections of regulatory documents (IND, MAAs)
• Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and to present information in an advisory capacity.
• Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
• Able to travel up to 25%.
• Ability to work both independently and collaboratively with project teams and cross-functionally, to build productive relationships with internal and external partners, to influence decision-making, and to engage in conflict resolution.

What You’ll Do:

The Senior Director, Quality Systems is a high-impact leadership role responsible for the architecture, implementation, and continuous improvement of our Enterprise Quality Management System (eQMS). You will report to the Vice President, Quality and will serve as the primary architect of our quality framework, ensuring our global operations remain compliant with GxP standards while maintaining the agility required of a growing biotech.

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

Responsibilities:

• Define and execute the long-term vision for the Quality Management System (QMS) to support global clinical development and future commercialization
• Provide Quality oversight for GxP systems change controls. Support validation planning, execution, approvals
• Act as the Business Owner for Veeva QualityVault. Lead the optimization of modules including Document Control, Training, Deviations, CAPA, and Change Control
• Establish and lead Quality Management Reviews (QMR). Develop and report on Key Quality Indicators (KQIs) and metrics to senior leadership to drive proactive risk management
• Ensure the QMS meets global regulatory requirements (FDA 21 CFR Parts 11, 210, 211, and 820; ICH E6; EudraLex Volume 4)
• Lead the QMS strategy for inspection readiness. Serve as a key interface during regulatory inspections (FDA, EMA, etc.) and oversee the internal and vendor audit programs
• Champion a culture of Quality. Streamline complex workflows to reduce cycle times for document approvals and deviation closures without compromising compliance
• Build and mentor a high-performing team of Quality professionals, fostering a collaborative environment that balances technical rigor with pragmatic problem-solving

Required Qualifications:

• 12+ years of experience in Quality Assurance within the Biotech/Pharmaceutical industry, with at least 5 years in a senior leadership capacity
• Direct experience implementing or managing Veeva QualityVault is mandatory. You should be proficient in configuring workflows and leveraging the platform for data-driven decision-making
• Proven track record in mid-sized companies navigating the transition from early-phase clinical trials to late-stage pivotal studies
• Deep knowledge of global GxP regulations and experience participating in (or leading) successful regulatory inspections
• Exceptional ability to translate complex quality requirements into actionable business strategies for non-quality stakeholders

Education:

• Bachelor’s degree required, scientific or engineering discipline preferred
• Advanced degree preferred

Position Description

The Manager, Gene Therapy Operations, is a critical role within the Patient Operations organization and is responsible for end-to-end (enrollment to infusion) oversight and execution of critical gene therapy supply chain operations for Genetix’s three commercially approved therapies.

This role partners closely with Manufacturing, Quality, Commercial Strategy & Operations, Sales, Systems Teams, and Logistics to ensure uninterrupted, world class patient and customer support.

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

Job Responsibilities

• Execute and manage the day-to-day supply chain and logistics operations of gene therapy from patient enrollment to infusion of drug product
• Coordinate patient scheduling with internal team, ensure scheduling tasks in associated systems and trackers are updated and communicated in a timely manner. Oversee the external CMO scheduling functions as appropriate
• Manage, maintain, and improve customer relationship with QTCs in partnership with apheresis and commercial teams
• Live monitoring and on call support during apheresis and final drug product logistics movements to ensure delivery is timely and secure
• Own and manage CMO slot utilization
• Execute tasks in accordance with all governing Policies, Standard Operating Procedures, Work Instructions, and Job Aids
• Contribute to a culture of continuous improvement, think proactively to offer solutions to problems

Required Education, Experience, and Qualifications

Required:

• Bachelor’s degree in Life Sciences, Engineering, or related discipline
• 5+ years of experience in pharmaceutical supply chain, planning, scheduling, gene therapy systems, project management, customer service and relationship management within the biotech industry
• Prior experience working in GxP regulated environments

Preferred:

• Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy supply chain

Key Competencies:

• Excellent attention to detail, must be able to manage and organize own work independently and in coordination with a team
• Ability to navigate systems such as Oracle, Traceability Systems, Veeva efficiently
• Excellent, clear, concise, and empathetic communication
• Able to execute tasks with a sense of urgency and manage time effectively. Must be comfortable operating in a fast-paced, evolving environment
• Ability to adapt to fluctuating relationship dynamics with internal and external partners

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.

Real Chemistry is looking for a Senior Strategist to join our growing team!

21GRAMS, part of Real Chemistry, takes an innovative approach to advertising, and focusing on making healthcare more human.  Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you?

21GRAMS is seeking a Senior Strategist to gather critical data that ensures strategies are accurate and planned accordingly. The Senior Strategist will write clear and forward-thinking strategies involving encouraging and advising creative teams. They will also research clients to understand them and their objectives while producing inventive ideas with team members. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, Lambertville, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:

• Lead and oversee competitive audits and analysis 
• Show deep command of brand and the brand’s category 
• Attend market research and provide key insights 
• Create research and insight decks 
• Help Strategy Director/Group Strategy Director with brand planning
• Assist with client workshops, oversee development of materials, and facilitate sections of the workshop and breakout groups 

• Manage/Mentor Strategists and Associate Strategists, helping them develop their skills and complete work at the highest levels of quality 

This position is a perfect fit for you if:

• Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
• You are highly organized self-starter, able to work independently and under tight deadlines.

What you should have:

• Bachelor’s Degree in business, marketing, or other related fields
• 2-3 years of experience in strategic management with integrated agencies
• Creative mind and ability to encourage and instigate ideation across departments
• Oral and written communication skills
• A leader that can coach, encourage, and mentor clients, staff, and team members
• Crucial problem-solving abilities
• Strong command for quantitative and qualitative research methodologies and solid understanding of when and how to apply them to a given client challenge

Pay Range: $100,000-$110,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

Real Chemistry is looking for an SVP, Brand Strategy to join our growing team!  

21GRAMS, part of Real Chemistry, takes an innovative approach to advertising, and focusing on making healthcare more human. Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you?

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, Lambertville or San Francisco—or remotely within the US, depending on team and business needs.

As the SVP, you will be a key leader responsible for shaping and executing our brand strategy to drive growth and enhance brand equity. You will work closely with executive leadership, cross functional teams, and external partners to develop and implement comprehensive brand strategies that align with our business objectives and resonate with our target audience.

What you’ll do: 

• Lead the development of brand positioning, messaging, and creative briefs that effectively communicate brand story
• Collaborate closely with cross-functional teams including Account Management, Creative, and Project Management teams to develop integrated omnichannel campaigns that deliver measurable results
• Stay abreast of industry trends, emerging technologies, and best practices in omnichannel marketing, and incorporate relevant insights into strategy development
• Develop and implementing comprehensive strategies that effectively reach target audiences, drive brand awareness, and ultimately, contribute to the success of our clients' campaigns
• Design and facilitate workshops. Lead Tactical and Brand planning.
• Conduct market research, consumer insights, and competitive analysis to identify trends, opportunities, and challenges in the marketplace
• Drive innovation in brand strategy and marketing approaches to stay ahead of industry trends and maintain a competitive edge
• Establish key performance indicators (KPIs) and metrics to measure the effectiveness of brand initiatives and campaigns, and use insights to inform future strategies
• Provide strategic guidance and mentorship to team members, fostering a culture of collaboration, creativity, and continuous learning

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• Bachelor’s degree in business administration, Marketing, or related field
• 10+ years of experience in Brand Strategy or related roles within an advertising agency, with a proven track record of developing and implementing successful brand strategies
• Strong leadership skills with the ability to inspire and motivate cross-functional teams
• Excellent analytical and problem-solving abilities, with a data-driven approach to decision-making
• Exceptional communication and presentation skills, with the ability to articulate complex ideas and strategies in a clear and compelling manner
• Demonstrated ability to thrive in a fast-paced, dynamic environment, managing multiple projects and priorities simultaneously

Pay Range: $240,000-$280,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

About Alltrna 

Alltrna is the first clinical-stage biotech company advancing tRNA medicines to address shared disease-causing mutations across many indications. The company’s initial therapeutic programs are designed to restore full-length protein production in diseases caused by premature termination codons (PTCs), collectively referred to as Stop Codon Disease, which affect approximately 10% of people with a rare genetic disease.

Alltrna’s lead program, AP003, is a chemically modified, engineered tRNA oligonucleotide encapsulated in a clinically validated, liver-directed lipid nanoparticle. AP003 is being developed for the arginine-to-TGA (Arg-TGA) PTC in patients with liver Stop Codon Disease, including phenylketonuria, organic acidemias, and urea cycle disorders. Founded in 2018 by Flagship Pioneering, Alltrna has built an integrated platform to design, optimize, and deliver engineered tRNA therapeutics. 

For more information, visit www.alltrna.com

Sr. Director Program Management & Business Operations

Position Summary:

Alltrna is seeking a talented and highly motivated Sr. Director Program Management and Business Operations, reporting to the President & CFO.  The successful candidate is a proven leader with extensive experience in leading research and early drug development program teams from research through the clinic with a particular initial focus on IND enabling and early/mid-stage clinical development. The candidate will be a member of the Company’s Leadership Team and will serve as Chief of Staff to the team to drive collaboration, cross-functional clarity, alignment and execution on key priorities and initiatives required to meet the goals of the organization.

Key Responsibilities:

Program Management:

• Work closely with the Chief Medical Officer to lead the program team for the Company’s lead program, AP003, and future programs instilling a culture of scientific rigor, open debate, collaborative teamwork, sense of urgency and accountability
• Possess a comprehensive understanding of the drug discovery process to guide program teams to define the key scientific questions, program strategy and objectives, translating these into optimal deliverables, cross-functional plans, timelines and budgets
• Identify bottlenecks, risks, issues and proactively develop appropriate mitigation proposals with input from team members
• Ensure all key decisions are identified and properly assessed as to their impact and alternative scenarios developed and evaluated, where appropriate
• Work closely with finance and functional teams to develop the operational plans to support program activities with realistic timelines, budget, and resource planning and monitor performance against plans
• Interface with and drive collaboration between the various functional teams and with the Leadership Team on program-related matters.
• Be the key accountable person for communicating matters related to the programs to management including strategy, work product, updates and issues; producing the one “source of truth” for program-related topics and timelines
• Point person for alliance management and coordination, as needed
• Lead and/or manage strategic or platform development projects as required and collaborate with Chief Scientific Officer and Research Leadership Team to coordinate relevant content for quarterly business review meetings

Operations:

• Collaborate with Leadership Team in development of strategic plans, company goals, long-range planning assumptions, portfolio-level reports and analyses to support business processes and strategic discussions
• Develop and deliver impactful presentations that effectively distill complex issues to the critical points and lead to increased understanding and optimized strategic planning & decision-making

• Prepare strategic communications utilizing a clear understanding of the business strategy and issues; develop and maintain consistent, relevant content for use in executive-level communications and to further organizational and business goals

• Lead the Scientific Communications process, working with the Scientific Communications Committee

• Manage schedule, agenda, and content for Leadership Team, Board of Directors and Town Hall meetings

• Proactively seek opportunities for organizational improvements (e.g. team structure, processes, communication, etc.)

Other:

• Support CEO / LT with partnership discussions and negotiations, including background research, preparation of presentation materials, supporting diligence activities, participating in analysis of terms, etc.
• Assist in mapping competitive landscape and proactively identify potential and emerging competitive threats and opportunities
• Promote strategic discussions on external trends, competitor strategies, and potential disruptors, and translate these into strategic choices/ recommendations
• Collect insights and intelligence from a variety of sources including literature searches, reviewing analyst research, KOL and patient group interactions, etc.

Key Competencies:

• This is a highly visible leadership role that requires exceptional interpersonal and communication skills, creative thinking, and early drug development experience that allows one to recognize opportunities/challenges and modify strategy accordingly
• The individual will need to have self-confidence and poise to manage complicated programs and projects with multiple stakeholders

• The individual will need a sense of urgency and can-do attitude to develop therapies for patients with significant unmet medical needs

Minimum Qualifications:

• BS/MS Degree in a scientific discipline, ideally life science or chemistry.
• At least 15 years relevant experience in pharma or biotech drug discovery and development, as well as a comprehensive understanding of drug discovery (preclinical and clinical).
• 10+ years of Program Management experience, preferably in early-stage drug discovery and development.
• Experience in the development of advanced therapies to treat rare genetic disease is a plus
• Demonstrated experience leading cross-functional teams; strong interpersonal and communication skills
• Scientific curiosity and passion for discovering new, innovative medicines.
• Openness to embrace new technologies and digital approaches in drug discovery
• Proven track record in driving successful, collaborative drug discovery teams.

The salary range for this role is $213,000 - $280,500. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Alltrna currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Alltrna's good faith estimate as of the date of publication and may be modified in the future.

POSITION OVERVIEW:

Syner-G is seeking a Sr. Program Manager (construction) to provide executive-level leadership, strategic direction, and oversight across large, complex capital programs involving multiple projects, cross-functional workstreams, and diverse stakeholder groups. This role is responsible for establishing and maintaining program governance, driving organizational alignment, managing program-level risks and financials, and ensuring capital initiatives are delivered safely, efficiently, and in accordance with regulatory and business requirements. The Sr. Program Manager serves as a trusted advisor to client leadership, guiding long-term capital planning, execution strategy, and continuous improvement across the program lifecycle.

WORK LOCATION:

Travel to client sites may be required based on project demands and client expectations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as necessary.)

• Provide senior-level leadership and direction across complex capital programs, ensuring alignment with organizational strategy, technical requirements, and client objectives.
• Develop and oversee program governance structures, communication frameworks, reporting systems, and decision-making processes.
• Lead program planning activities including scope definition, prioritization, resource planning, and long-range capital forecasting.
• Oversee program schedules, milestones, interdependencies, and resource allocation across multiple concurrent projects.
• Identify and manage program-level risks, issues, and constraints, ensuring mitigation strategies are developed and implemented.
• Coordinate and align cross-functional teams including engineering, construction, operations, procurement, finance, quality, and safety.
• Review and approve program documentation including design packages, technical deliverables, construction plans, and compliance documentation.
• Facilitate communication between internal teams, external partners, contractors, and executive stakeholders to ensure clarity and alignment.
• Lead executive-level program reviews, steering committee meetings, and strategic planning sessions.
• Ensure program activities comply with applicable codes, standards, regulatory requirements, and internal procedures.
• Oversee program budgets, forecasts, financial performance, and cost-control strategies.
• Manage program-level change control processes, ensuring impacts are evaluated, documented, and communicated.
• Support commissioning, qualification, and operational readiness activities across the program.
• Prepare program reports, dashboards, and executive summaries to communicate progress, risks, and performance indicators.
• Drive continuous improvement initiatives, organizational learning, and long-term capital program optimization.
• Provide mentorship and leadership to project managers, engineers, and program support staff.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below represent the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education:

• Bachelor’s degree in engineering, construction management, project management, or a related technical field preferred.
• PMP, PgMP, or similar program management certification is strongly preferred.

Technical Experience:

• 7-15 years of experience in capital project management, program management, engineering leadership, or related roles.
• Extensive experience managing large-scale capital programs involving multiple projects, stakeholders, and technical disciplines.
• Experience working in regulated or complex environments such as biotech, pharmaceutical, industrial, or advanced manufacturing.
• Deep understanding of capital project lifecycles, design coordination, construction execution, commissioning, and operational readiness.
• Experience with program governance, risk management, resource planning, financial oversight, and executive communication.
• Proven ability to lead cross-functional teams and manage complex stakeholder environments.

Knowledge, Skills, and Abilities:

• Exceptional leadership and communication skills with the ability to influence at all organizational levels.
• Proficiency with program and project management tools, scheduling software, and reporting platforms.
• Strategic thinker with strong analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and drive program execution in fast-paced, dynamic environments.
• Ability to build and maintain strong relationships with clients, stakeholders, and cross-functional partners.
• Ability to lead through ambiguity and guide teams toward clear, actionable outcomes.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

Real Chemistry is looking for an Account Director to join our growing Medical Communications team! We are open to Account Director, Senior Account Director, and Group Account Director level candidates!

The Account Director for the Scientific and Medical Affairs team serves as the primary client contact, leading client relationships of ~$2M, providing strategic counsel, and overseeing the successful execution of projects for emerging and mid-stage biotech companies as part of our Biotech Center of Excellence (COE). You will ensure high-quality deliverables, proactively identify opportunities for account growth, and manage internal teams effectively. 

This is a hybrid role based in our Boston office. 

What You’ll Do: 

• Serve as the day-to-day client lead and trusted advisor for emerging and mid-stage biotech partners across medical affairs and publication workstreams, leveraging our Biotech COE
• Provide senior-level strategic counsel on key programs, tailoring recommendations to the realities of emerging and mid-stage biotech (e.g., evolving evidence, rapid timelines, and lean teams).
• Oversee account operations to ensure seamless execution of high-quality deliverables - driving proactive issue resolution, clear stakeholder communication, and consistent delivery standards across the Biotech COE
• Drive strategic planning and account growth by identifying opportunities to evolve and expand programs for existing and identified emerging and mid-stage biotech clients. 
• Ensure financial stewardship across the account, including budget oversight, forecasting, resourcing, and profitability management.
• Mentor and develop team members, fostering a collaborative, high-performing environment and contributing to capability-building within the Biotech COE.
• Stay current on industry trends, competitor activity, and relevant regulatory updates - translating insights into practical guidance for biotech clients.
• Support new business efforts for emerging and mid-stage biotech, contributing to pitches and proposals and partnering with the Biotech COE to showcase differentiated expertise. 

What You Should Have: 

• 6+ years of experience in medical affairs and ideally publications, in an agency setting.
• Minimum of 3 years of experience servicing biotech clients.
• Proven leadership skills, with experience managing client relationships and internal teams.
• Strong strategic thinking and problem-solving abilities, with a track record of driving account growth.
• Exceptional communication and presentation skills, with the ability to influence and engage stakeholders at all levels.
• Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
• Proficiency in financial management, including budget tracking and forecasting.
• Experience with Advisory boards, investigator meetings, and meeting management.
• Veeva management expertise (preferred but not required).
• Bachelor’s degree or equivalent work experience required. 

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

Job Summary

Real Chemistry has a newly created role on our growing Treasury Team and we are seeking an experienced Treasury Analyst to join as we expand our department to support company growth.  This role will provide operational support on all treasury matters for the company, including such areas as Bank Account Management and Cash Management, reporting to the Manager of Treasury – Cash Operations.  The Treasury Analyst role requires the ability to establish and maintain strong working relationships within a collaborative team and serve as a liaison to business units and external banking partners.

Responsibilities –

Responsibilities include, but are not limited to, the following:

• Cash & Liquidity Management
  • Prepare daily cash reports of worldwide cash balances on a weekly basis for distribution to appropriate parties
  • Monitor daily cash positioning of respective accounts and communicate cash liquidity or any potential liquidity needs based on current cash flow forecasting models and actual transaction activity
  • Assist in effective cash management strategies with short-term investment/redemption recommendations for cash coverage purposes as well as cash consolidation analysis to the Manager of Treasury
• Bank Account Management
  • Maintain the Master bank account database and tracking of current bank requests
  • Manage and execute all requests relating to authorized signer updates, opening and/or closing of bank accounts
  • Liaise with our banking partners to follow up and ensure proper bank account setups, products & services related to accounts are added, and servicing any other banking needs or troubleshooting for the various business units.
  • Work closely with banking institutions to mitigate fraud risk, settle discrepancies and assist with banking integrations
  • Ensure banking institutions are provided with any required documentation as requested including KYC
  • Serve as additional Security Administrator on banking platforms
• Treasury Operations
  • Assist in transition of the banking relationships and implementation of banking infrastructures, as needed, related to the integration of newly acquired companies and/or global expansion initiatives
  • Support the implementation of any Treasury related systems and/or platforms
  • Participate in post-acquisition integration projects, internally and externally, for Treasury functions
  • Complete administrative tasks in conjunction with the Manager of Treasury for existing Debt Facilities such as committed loan notices, rate reset continuation letters, as well as any associated tracking and/or calculations.
  • Adhere to and aid in the documentation of appropriate Internal controls for Treasury processes
  • Additional duties, special projects, and ad hoc analyses as necessary

Required Knowledge & Skills –

• Strong analytical and problem-solving skills
• Detailed oriented, strong attention to accuracy, and self-motivated
• Hard-working, reliable team player and fast learner
• Excellent verbal and written communication skills

Required Education & Experience -

• Bachelor’s degree in finance, accounting, business, or another related field
• MBA, CTP strongly preferred
• Minimum 3-5 years of prior work experience, preferably in a Treasury, Banking, or Finance role
• Experience with banking and e-commerce software and websites (including JPM ACCESS, CIBC, Citi, HSBC, First Merchants, State Street FundConnect, Morgan Money)
• Microsoft Windows and Office proficiency
• Advanced Microsoft Excel skills
• TMS/ERP  preferred (Trovata/NetSuite)
• Solid understanding of Accounting, Finance, and Business principles

Pay Range: $60,000-$70,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

Job Summary:

Real Chemistry is looking for an Associate Strategy Director to join our growing team!

21GRAMS, part of Real Chemistry, takes an innovative approach to advertising, and focusing on making healthcare more human. Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you?

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, Lambertville, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:

As the Associate Strategy Director, you will be a key leader responsible for shaping and executing our brand strategy to drive growth and enhance brand equity. You will work closely with executive leadership, cross functional teams, and external partners to develop and implement comprehensive brand strategies that align with our business objectives and resonate with our target audience.

Responsibilities

• Lead the development of brand positioning, messaging, and creative briefs that effectively communicate brand story
• Collaborate closely with cross-functional teams including Account Management, Creative, and Project Management teams to develop integrated omnichannel campaigns that deliver measurable results
• Stay abreast of industry trends, emerging technologies, and best practices in omnichannel marketing, and incorporate relevant insights into strategy development
• Develop and implementing comprehensive strategies that effectively reach target audiences, drive brand awareness, and ultimately, contribute to the success of our clients' campaigns
• Design and facilitate workshops. Lead Tactical and Brand planning.
• Conduct market research, consumer insights, and competitive analysis to identify trends, opportunities, and challenges in the marketplace
• Drive innovation in brand strategy and marketing approaches to stay ahead of industry trends and maintain a competitive edge
• Establish key performance indicators (KPIs) and metrics to measure the effectiveness of brand initiatives and campaigns, and use insights to inform future strategies
• Provide strategic guidance and mentorship to team members, fostering a culture of collaboration, creativity, and continuous learning

This position is a perfect fit for you if: 

• Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.
• You are a highly organized self-starter, able to work independently and under tight deadlines.

What you should have:

• Bachelor’s Degree in Business Administration, Marketing, or related field
•  Experience in Brand Strategy or related roles within an advertising agency, with a proven track record of developing and implementing successful brand strategies
• Strong leadership skills with the ability to inspire and motivate cross-functional teams
• Excellent analytical and problem-solving abilities, with a data-driven approach to decision-making
• Exceptional communication and presentation skills, with the ability to articulate complex ideas and strategies in a clear and compelling manner
• Demonstrated ability to thrive in a fast-paced, dynamic environment, managing multiple projects and priorities simultaneously

Pay Range: $125,000-$138,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

Job Description

As an AI Integration Engineer you will play a pivotal role in developing and implementing artificial intelligence solutions that will transform our internal systems and operations. You will work closely with others in the technology team and across various departments to identify areas where AI can improve efficiencies and drive data-driven decision-making. This is a technical hands-on role helping to configure and optimize a variety of technologies.

What you’ll do: 

• Set up and configure the next generation of AI software.
• Design and build integrations for AI tooling to core systems and data.
• In a fast-moving space you’ll be exposed to new tools on a regular basis.
• Integrate AI tools with existing data and systems via API’s and automations.
• Collaborate with various departments to understand their requirements and provide AI solutions.
• Ensure seamless integration and functionality of AI tools within the cloud infrastructure.
• Stay updated with the latest advancements in AI and related technologies.
• Troubleshoot and resolve any issues related to AI tools and their integration.
• Provide training and support to team members on the use of AI tools.

What you should have: 

• Bachelor's degree in Computer Science, Information Technology, or a related field.
• 3+ years of proven experience as a technology professional in a cloud first and progressive IT environment.
• Strong understanding of and a passion for AI.
• Familiarity with the latest LLMs and AI products and their capabilities.
• Proven experience in setting up and configuring AI tools.
• Strong understanding of cloud-based infrastructure and services.
• Ability to switch between different technologies and quickly master new ones.
• Experience in scripting languages such as Python, Ruby, or JavaScript.
• Familiarity with data formats such as JSON, XML, and CSV, and their transformations.
• Experience with OpenAI, Workato and Databricks is preferred.
• Excellent problem-solving skills and attention to detail.
• Strong communication and collaboration skills.
• Passion for technology and continuous learning.
• Healthcare or Advertising industry experience a plus
• Ability to work in an Agile environment and handle multiple projects simultaneously.

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are highly organized self-starter, able to work independently and under tight deadlines. 

Pay Range: $110,000-$120,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

About the Role >>> Senior Director, Global Regulatory Strategy 

As the Senior Director, Global Regulatory Strategy reporting to the Senior Vice President of Regulatory Affairs, your main responsibilities will include the following:  

• Leading the development and execution of innovative regulatory strategies supporting Olema products  
• Representing Regulatory Affairs on cross-functional teams as the subject matter expert and providing regulatory guidance and oversight to the global project teams
• Providing strategic and tactical guidance and leading the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, BLA, IMPD etc.)  

This role is based either out of our Boston, MA or San Francisco, CA office and will require domestic and international travel up to 20%. 

Your work will primarily encompass:  

• Develop innovative global regulatory strategies for the Olema portfolio of products, in clinical development and life-cycle management, as needed  
• Represent Regulatory Affairs as the SME across cross-functional teams and provide regulatory guidance/oversight to the global project teams, Study Execution Teams, and the Executive Committee  
• Stay abreast of the regulatory landscape and regulatory requirements impacting drugs, biologics and devices (e.g., companion diagnostics)  
• Be accountable for, provide both strategic and tactical guidance and lead the development of regulatory submissions (INDs, CTX, briefing documents, IB, NDA, BLA, DSUR, IMPD etc.)  
• Represent Olema with global Health Authorities and lead Agency interactions to achieve company objectives  
• Proactively identify gaps and develop risk mitigation strategies for regulatory submissions in alignment with the team(s) and management 
• Ensure Olema’s regulatory activities are robust and in compliance with Health Authority (HA) regulatory requirements  
• Coordinate and maintain all HA reporting schedules in collaboration of cross-functional teams  
• Serve as the point of contact with external parties and vendors supporting regulatory activities (e.g., CROs, contractors etc)   
• Participate in and contribute to cross-functional and departmental objectives  
• Maintain flexibility to adapt and accommodate additional duties as assigned  

And will also include the following:  

• Lead the development of Regulatory Affairs department policies, SOPs, and work instructions  
• Provide Regulatory guidance and leadership to cross-functional teams on software implementation for Regulatory dossiers (e.g., Veeva)  
• Keep the Leadership and the organization fully informed of the regulatory landscape, including HA initiatives, policies and their potential impact on Olema’s programs  
• Lead the global Regulatory team(s) and ensure execution of the regulatory strategies to achieve company objectives  
• Mentor and develop colleagues in the Regulatory department   

Ideal Candidate Profile  >>> Innovative Experienced Regulatory Strategy Leader  

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 a scientific discipline  
• Advanced degree in scientific discipline Masters, Pharm D or PhD is preferred   

Experience:  

• 12 years’ experience in Regulatory Affairs in Pharma/Biotech  
• Minimum of 3 years direct leadership experience  
• Strong negotiation skills with health authorities (viz., FDA, EMA, Health Canada, etc.) as well as submissions  
• Experience with leading the NDA/BLA or Marketing Applications is desirable.) 
• Experience in Oncology Therapeutic area is required 
• Experience with development and execution of regulatory strategies in Oncology TA is required  
• Ability to work in a fast-paced environment in a hands-on fashion  
• Excellent oral, written, and presentation skills  
• Strong organizational skills  

Attributes:  

• Self-starter  
• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities

The base pay range for this position is expected to be $270,000 - $290,000 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

About the Role:

Stylus Medicine is seeking a highly motivated and collaborative Senior Scientist to join our in vivo Pharmacology team. This role will be responsible for leading NHP studies, including working closely with CROs to manage studies, contribute to protocol writing and design, obtain, quality control, analyze and interpret data, lead investigative technical troubleshooting, ensure consistency in execution across studies, and create detailed and thorough study summaries. Reporting to the Director of in vivo Pharmacology and working closely with cross-functional teams, this is a unique opportunity to contribute to foundational development in a fast-paced, cutting-edge biotech environment and advance the development of transformative in vivo genetic medicines.

Key Responsibilities & Accountabilities: 

• Design NHP study protocols and lead CRO communication
• Analyze, interpret, and communicate NHP study data, including flow cytometry analysis, cytokine analysis and other ex vivo readouts, to inform project direction and decision-making
• Evaluate data for consistency and follow-up as needed, working closely with CROs to optimize study protocols
• Investigate and interpret biological findings from NHP studies
• Manage NHP study test article generation and transfer in collaboration with internal cross-functional teams
• Conduct experiments to optimize protocols for CRO transfer or investigate biological findings
• Generate and manage study documentation, including protocols and study reports
• Effectively communicate findings to internal teams.
• Maintain detailed and accurate laboratory records in compliance with data integrity and documentation standards
• Limited travel may be required

 Qualifications & Skills:

• PhD in Pharmacology, Immunology, Immuno-oncology, or a related field with 4-6 years of relevant industry or academic experience, or a Master's degree with 8+ years of experience
• Demonstrated experience with ex vivo analytical techniques, such as flow cytometry, cytokine analysis, and ddPCR
• Demonstrated ability to design, execute, interpret, and troubleshoot immunology-related in vivo studies and to coordinate the activities of multiple study contributors
• Experience coordinating with animal vendors, CROs or external collaborators
• Prior experience with NHP studies is preferred
• Experience in designing experiments to address PK/PD/biodistribution/tox relationships is a plus
• Experience with LNP or CART delivery technologies and genetic medicine platforms is a plus
• Experience with T cell or PBMC isolation and handling from peripheral blood, engineering, and downstream immunological or molecular assays
• Demonstrated ability to work independently in a laboratory setting, learn new techniques, multitask effectively, and maintain meticulous records
• Demonstrated proficiency in documenting and maintaining an organized lab notebook, lab inventory, and experimental results
• Excellent organizational and communication skills, with a team-first mindset and the ability to convey technical information
• Analytical thinker with the ability to distill complex data into clear, actionable insights

Pay Range: $160,000 - $175,000

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. 

The Role: 

This critical role will manage the tactical execution of marketing operations supporting the launch of bezuclastinib, Cogent Biosciences’ key pipeline asset. This role ensures compliant, efficient, and impactful delivery of promotional content, omnichannel campaigns, key marketing KPI’s. This role is critical to implementing. evolving and advancing our organization’s omnichannel capabilities. The Senior Manager partners closely with brand leads to unify personal and non-personal promotional activities into a seamless customer experience that drives brand performance goals and commercial growth.

Responsibilities:

• Omnichannel Campaign Orchestration
  • Work with marketing to ensure the execution of complex customer engagement plans into high-performing omnichannel campaigns across HCP, patient, and caregiver audiences.
  • Collaborate with analytics teams to integrate insights into campaign design and optimization.
  • Ensure systems and platforms readiness to track key data and metrics for campaign effectiveness and measurement.
  • Ensure personalization and precision in outreach, leveraging data and segmentation strategies.
• Promotional Review & Content Approval
  • Manage the Cogent internal promotional review process (MLR) and understand the end-to-end content approval process for key commercial materials.
  • Ensure timely and compliant review of promotional materials, including HCP and patient-facing assets.
  • Understand the critical systems supporting these processes such as Veeva Vault PromoMats and ensure system optimization for content approval workflows. 
• Agency & Vendor Management 
  • Assist in agency selection, onboarding, performance tracking, and contract alignment. 
  • Establish KPIs and ensure high-quality deliverables that support brand objectives and scientific integrity.
• Governance
  • Maintain SOPs and process documentation tailored to the key indications for bezuclastinib marketing operations

Job Title: Delivery and Success Associate - Enterprise
Employment Status: Full-time
Office Hours: Monday - Friday; hybrid schedule
Location: Boston, Massachusetts
Compensation: $62,000 - $75,000 base + variable + equity options
*compensation may be negotiated based on experience level

About Ketryx:

Ketryx is an AI software platform that enables healthcare life sciences companies to ship life-saving regulated products in weeks instead of years.

Exploding product complexity is burying companies in compliance paperwork and blocking innovation. Our AI software removes this friction, dissolving the historical tradeoff between innovation and compliance, and enables regulated industries to innovate at the pace of modern software.

Just two years since launch, Ketryx already touches the lives of 25M patients and powers 3 of the world’s top 5 MedTech companies and 25% of the Fortune 500 MedTech market. Backed by Lightspeed Ventures, our founders are the former Head of AI at Amgen and CTO of Wolfram Cloud.

Healthcare and life sciences is just the beginning for us. Automotive, aerospace, energy — if it’s regulated, it’s because society decided it matters. These products move humanity, shape our future, and are safety-critical. Come join us and help build the AI platform to power safe innovation.

The role

As a Delivery and Success Associate - Enterprise, you’ll work closely with customers who rely on Ketryx to manage safety‑critical and regulated development processes. This is a technical, engineering‑adjacent role.

You’ll support customers from onboarding through long‑term partnership, helping configure the Ketryx platform, supporting requirements and quality workflows, and applying structured problem solving to real challenges. You’ll develop a deep understanding of how regulated teams build, verify, and validate software.

This is an excellent opportunity for early‑career engineers or technically trained professionals who want exposure to regulated industries, verification & validation practices, and customer‑facing technical work, while growing alongside a mission‑driven team.

About you

You bring an engineering mindset to your work. You like understanding how systems fit together, why processes exist, and how to improve them. You’re comfortable learning complex concepts and applying structure and logic to ambiguous problems.

You’re excited by the opportunity to work close to engineering, quality, and regulated product development, while also collaborating directly with customers.

You’re curious, detail‑oriented, and motivated by meaningful work that has real‑world impact.

Responsibilities 

• Support Customer Success: Partner with clients during onboarding and ongoing use of the Ketryx platform, helping them apply best practices for requirements, verification, and quality workflows.
• Configure and Support the Platform: Assist with configuring Ketryx to align with customer development processes, including requirements traceability, documentation workflows, and validation artifacts.
• Apply Engineering & Quality Thinking: Help customers reason through leaving evidence, verification activities, and structured development processes commonly used in regulated and safety‑critical environments.
• Troubleshoot and Problem‑Solve: Investigate technical and workflow challenges, escalate thoughtfully when needed, and follow through to resolution.
• Collaborate Cross‑Functionally: Share customer insights with Product, Engineering, and Quality teams to help improve the platform and internal processes.
• Support Quality & Compliance Efforts: Contribute to accurate, well‑structured documentation within the Quality Management System (QMS) and reinforce strong process discipline.
• Grow Your Technical Skill Set: Build fluency in regulated software development concepts such as requirements management, verification & validation (V&V), and the V‑model.

Required Skills

• Technical or Engineering Background: Bachelor’s degree in engineering, computer science, or a related technical field (or equivalent hands‑on technical experience).
• Exposure to Structured Development: Familiarity with concepts such as requirements, verification & validation, testing, systems engineering, or the V‑model (academic or professional exposure is sufficient).
• Interest in Regulated Industries: Curiosity about or comfort working in regulated, safety‑critical environments (medical devices, biotech, pharma, aerospace, automotive, etc.). Prior regulated experience is a plus, not a requirement.
• Technical Communication Skills: Ability to understand and explain technical concepts clearly, both verbally and in writing.
• Analytical Problem‑Solving: Comfort troubleshooting issues, asking good questions, and reasoning through complex workflows.
• Collaborative Mindset: Enjoys working across teams and building trusted relationships with customers and teammates.

Preferred Skills

• Experience in customer success, professional services, or product operations in B2B SaaS.
• Background in quality, regulatory affairs, or systems engineering.
• Familiarity with Software as a Medical Device (SaMD).
• Experience working in an early stage, product-based start up.

Keywords: customer success, client operations, delivery and success, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, client management, quality, regulatory, system engineer, B2B, regulation, task management, project management, Greater Boston, MA, SQL, KQL, python, java

New Business Designer

About Real Chemistry

At Real Chemistry, making the world a healthier place isn’t just an aspiration—it’s our everyday reality. We combine deep scientific expertise, human‑centered creativity, and data‑driven intelligence to help healthcare brands make meaningful impact. Our Enterprise New Business team plays a critical role in shaping how we show up to prospective clients—bringing clarity, creativity, and polish to high‑stakes pitches and growth opportunities.

The Role

We are looking for a Freelance New Business Designer to join our Enterprise New Business team. This is a highly executional, individual‑contributor role focused primarily on PowerPoint design, including custom pitch templates, layout systems, and presentation polish, with graphic design support as needed.

You will work closely with new business, strategy, and creative partners to help transform complex ideas into clear, visually compelling pitch materials that support Real Chemistry’s growth efforts.

What You’ll Do

• Design and build high‑impact pitch decks primarily in PowerPoint, ensuring clarity, consistency, and visual polish
• Create custom PowerPoint templates and slide systems tailored to individual new business opportunities, while aligning with Real Chemistry brand guidelines
• Translate strategic and written content into clean, engaging layouts that tell a cohesive story
• Apply lgraphic design support as needed (e.g., charts, icons, simple illustrations, visual frameworks)
• Partner closely with new business, strategy, and creative teams to meet tight deadlines and evolving pitch needs
• Ensure all materials meet Real Chemistry’s quality, accessibility, and brand standards

What You Bring

• 8-10+ years of experience in presentation design, design production, or similar role, preferably within an agency, consulting, or new business environment
• Advanced proficiency in PowerPoint, with a strong understanding of master slides, templates, and layout systems
• Solid design fundamentals, including typography, layout, hierarchy, and visual storytelling
• Experience with graphic design using tools such as Adobe Creative Suite (e.g., Illustrator, InDesign) or comparable tools
• Ability to work quickly and accurately under tight deadlines while maintaining attention to detail
• A collaborative, solutions‑oriented mindset and comfort working with cross‑functional partners

Nice to Have

• Experience supporting new business, pitches, RFIs/RFPs, or growth initiatives
• Familiarity with healthcare, life sciences, or highly regulated industries
• Experience adapting or extending established brand systems within presentations

Why Real Chemistry

• Join a high‑visibility enterprise new business team supporting growth across the organization
• Work on a wide range of strategic, creative, and high‑stakes pitch opportunities
• Collaborate with talented teams across strategy, creative, data, and medical
• Flexible, remote‑friendly work environment rooted in Real Chemistry’s people‑first culture

Pay Range: $75-85 per hour 

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time

Real Chemistry is looking for an Audio Engineer, Sound Innovation to join our growing team!  

21GRAMS, Real Chemistry’s advertising agency, has done a lot in its first 5+ years. Known for our creativity, we've just been ranked as the #2 creative health agency in the world by Cannes Lions. It takes a team to do ambitious things, and our ambition is to help people connect with healthcare – by making advertising less of an interruption and more worth people’s time because it actually gets them. As an agency with the full capabilities of Real Chemistry at our fingertips, we’ve got endless potential.

ROOM42, Real Chemistry’s in-house production company, is hiring an experienced Audio Production Lead to join our in-house production team. The ideal candidate will possess strong skills in sound editing and mixing. Should be familiar with audio post-production workflows - sound design and mixing for film and video, as well as podcast production. Also be comfortable leading remote recording sessions, directing talent and managing communication between team members. A requirement of this role is to have a strong interest and expertise in generative AI software and workflows related to the audio production industry.

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, Lambertville, or San Francisco—or remotely within the US, depending on team and business needs. This role will work according to the Eastern Time zone.

What you’ll do: 

·       Collaborate with team members on creative and efficient ways to incorporate AI into audio production and post-production workflows.

·       Sound design, editing, and mixing for all sorts of projects, ranging from documentary-style films to scripted advertisements, talking heads, animated instructional videos, radio spots, podcasts, sonic branding, and anything else our Creatives can come up with.

·       Manage the casting, directing, recording, and editing of voiceover talent, both AI and real people.

·       Podcast Production: collaborate with team members to develop structure, format, and workflow (incorporating AI) for different podcast series. Manage all recording, editing, and mixing.

·       Contribute and collaborate in a high-volume, fast-paced team environment, maintaining high standards of audio quality.

·       Maintain freshness, creative excellence, and innovation to uphold and enhance the brand.

·       Stay updated on trends and advancements in audio production, post-production, and sound design (especially utilizing generative AI), using this knowledge to inform work and push creative boundaries.

·       Direct and manage the work of outside contractors and freelancers as needed.

This position is a perfect fit for you if: 

·   ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

·   You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

·   You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

·   You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

·       4+ years of professional experience in audio post-production (experience in a corporate environment, agency – specifically healthcare agency is a plus but not required).

·       Background in music production – a plus but not required.

·       Proficiency in Pro Tools required, familiarity with Adobe Suite is an advantage.

·       Comprehensive knowledge of the latest audio production tools, both traditional and those utilizing AI.

·       Expertise in voiceover recording, directing, and editing.

·       Proficiency with Microsoft Suite, Box, and Frame.io in a corporate environment and the ability to quickly learn and incorporate new software and systems.

·       Strong understanding of broadcast, digital, social, and standard delivery specifications.

·       Excellent communication skills, including the ability to articulate creative concepts and rationale for clients and the team.

·       Exceptionally high creative standards, balanced with an understanding of timeline and budget constraints.

Pay Range: $,100,000 - $115,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

21GRAMS, a Real Chemistry subsidiary is an advertising agency born to make healthcare more human. Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

Role summary:  

21GRAMS is in search of a Senior Art Director to generate and delivery quality creative materials. Art directors are responsible for the visual style, art, images and photographs and must adhere to client’s marketing strategies, objectives, and expectations. The main objective is to promote business growth by developing groundbreaking creative concepts

What you'll do:

• Develop and execute creative marketing strategies that encompasses and meets the client’s marketing strategies and objectives

• Understand and maintain understanding of client’s positions and the current marketing environment to adapt and navigate to success

• Oversee a team to ensure quality for a final product

• Communicate with team members in a productive manner to ensure goals are being met

• Think strategically with understanding of assigned accounts, medical categories, and market

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  

• You are highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• Bachelor’s Degree

• 3+ years of healthcare advertising experience preferred

• Experience in healthcare advertising

• Effective oral and written communication skills

• Computer proficiency with knowledge of design programs

• Managerial and leadership skills and the ability to work with a team

• Decisive problem-solving abilities

Pay Range: $100,000.00-$115,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

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.

Real Chemistry is looking for a Group Copy Supervisor to join our growing team!  

21GRAMS, part of Real Chemistry, takes an innovative approach to advertising, and focusing on making healthcare more human.  Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

The Group Copy Supervisor is a brand steward and category champion, responsible for having a deep understanding of the brand, its benefits, and competitive differentiation. Working with art partners and reporting to a Creative Director, the Group Copy Supervisor will own all day-to-day writing responsibilities for assigned healthcare/pharma-related HCP accounts. The ideal candidate will have the skills and experience to think strategically, supply creative ideas and concepts, and execute across a range of mediums.

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do: 

• Responsible for writing headlines and body copy for various types of digital tactics, including websites, interactive visual aids, videos, banners, landing pages, and emails, for branded and unbranded HCP clients

• Convey scientific information into compelling and memorable messages for HCP campaigns

• Champion creative thinking for campaigns and initiatives that advance creative strategy and brand personality

• Prepare materials for client copy approval submissions, ensuring pieces are referenced and annotated according to AMA style, without supervision

• Collaborate with Art Directors, Designers, and Developers from job initiation to digital deployment, and partner with Account and Strategy teams at all points

• Ability to independently lead multiple projects, sometimes for different brands/industries

• Clearly and expertly present work to clients and internal team members

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• 7+ years healthcare/pharmaceutical writing, preferably in an agency setting

• College degree in a related field preferred

• Experience writing for the healthcare/pharmaceutical industry

• Portfolio or PDF of relevant work samples required

Pay Range: $120,000 - $135,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

Real Chemistry is looking for a Account Manager/Senior Account Manager join our growing team!   

The Account Manager/Senior Account Manager for the Scientific and Medical Affairs is the client’s key day-to-day contact, managing relationships and helping to set their expectations of the agency. You make sure that your colleagues know what is going on and are delivering effectively. You are thinking about future opportunities as well as today’s work.   

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do:  

• Day-to-day client contact: provide regular status updates to your client; respond to client queries and share recommendations (following discussion with your account lead); manage client expectations on timelines, scope of project, etc.; take client briefs and clearly communicate to team members, implementing realistic project plans  
• Take responsibility for the day-to-day management of your account, including managing the processes of the account (including running regular internal team meetings), flow of work, delegation of tasks (oversee status reports to ensure all team actions are complete) and the status of jobs across the account (not just your own)  
• Ownership of and accountability for medium/large client projects, ensuring that projects are delivered to highest possible standards within budget and agreed timeframes  
• Ongoing communication with your account lead on the progress of projects; alerting them to any barriers to project completion and being proactive in making recommendations and proposing solutions on how to proceed  
• Awareness of the client’s business priorities and a sound understanding of the program strategy; have a good understanding of competitor activity  
• Keep abreast of trends and developments in the medical communications and pharma industries  
• Start to identify areas for growth (evolving existing programs and/or additional tactics), proactively sharing new ideas with your team and client  
• Keep abreast of market changes  
• Be proactive when new business opportunities arise, flagging relevant experience and areas of interest, contributing thoughts and ideas, assisting in the production of credentials and pitch presentations  
• Maintains general understanding of account finances; supports account lead with financial management  
• Support new business research and ideation, participate in pitch presentations as required 
• Continued professional development engagement; work with manager to identify training opportunities based on areas of interest and need  

This position is a perfect fit for you if:  

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you.  
• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving.  
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data.  
• You are a highly organized self-starter, able to work independently and under tight deadlines.  

What you should have:   

• A minimum of 3 years of prior experience in healthcare agency client services roles with medical affairs, publications, and/or medical information experience required 
• Highly organized with a mindfulness of deadlines, the ability to manage multiple tasks based on priorities and a strong attention to detail  
• Independent thinker confident in taking ownership of assets and material development, but a team player who enjoys collaboration  
• Professional presence, performs with a sense of urgency and with a client service orientation  
• Has confidence to manage upward when required; able to communicate with managers when deadlines will not be met or when issues are foreseeable  
• High energy, able to effectively operate in fast-paced, growing and evolving environment  
• Demonstrated strong work ethic, with a track record of following through on client requests and with high-quality deliverables on schedule and on budget  
• Able to work independently and as part of a team 
• Competent in using Microsoft Word, PowerPoint, Excel, and Outlook 
• Experienced in developing client relationships and networking 
• Strong financial acumen 
• Comprehension of project and account objectives, contributing to strategic planning 
• Able to devise and articulate solutions to problems on an ongoing basis  
• Able to clearly communicate project updates, scopes and recommendations to clients  
• Veeva management and/or iEnvision experience recommended but not required  
• BA or equivalent work experience required  

Pay Range: $70,000.00-$100,000.00

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.  

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.

Pay Range: $75,000-$90,000

This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. 

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing. 

The Role: The Senior Manager of Trade and Distribution will be responsible for management of Cogent Bioscience’s network of Specialty Distributor accounts.  The Key responsibilities will be to oversee the physical and financial flow of the Cogent Biosciences portfolio beginning with the launch of Bezuclastinib. The candidate will be the primary for Specialty Distributor customers tasked with maintaining relationships and growing Cogent Biosciences business while contributing to the evolving channel strategy for products. This candidate will oversee all aspects of business operations within assigned customers including inventory management, product fulfillment, data flow and management of returns. The individual will report to the Executive Director Trade & Distribution within the Market Access team and work closely with Corporate Accounts, Payer Accounts, Field Sales, Patient Access Services and Commercial Operations as well as other internal Cogent Biosciences colleagues.

Responsibilities:

• Strategic Relationship Management- Serve as the primary point of contact for 5 core specialty distributors. Lead quarterly business reviews, negotiate fee for service agreements and monitor contract compliance.
• Sustain long-term customer partnerships with assigned accounts, based on a deep understanding of the customer organization, structure, business strategy, and priorities.
• Ability to build effective business plans that align with access goals to support brand and market access strategies.
• Develop contract negotiation and execution strategies with leadership team, including pre-contract financial ROI analysis, contract language negotiation, execution, post contract measurement and analysis. 
• Supply Chain Integrity-Ensure seamless distribution of high value products and manage inventory to ensure patient access.
• Data & Analytics- Monitor 852/867 data feeds to track product movement, inventory levels and channel pull through.
• Cross Functional Collaboration- Partner with colleagues from Market Access, Supply Chain, Commercial Ops, Quality, Patient Services and Marketing to ensure distribution model supports the overall patient journey and brand strategy.
• Trade Operations- Oversee the order to cash process, manage chargebacks, returns and any distribution related discrepancies within customers.
• Ensure strategies and KPIs are implemented and monitored to achieve our commercial goals while working within the assigned budget.
• Works within Cogent’s compliance policies.
• This is a hybrid role and the candidate will need to be in the Waltham MA office 2 days per week.

Real Chemistry is looking for a Client Accounting Analyst join our growing team!  

Boston - Massachusetts; Carmel - Indiana; Chicago - Illinois; Lambertville - New Jersey; North Carolina 

The Client Accounting Analyst is responsible for the facilitation of the billing process, financial analysis, and reporting for assigned accounts. The Client Accounting Analyst is part of the Finance Department and works closely with other members of the department. This is a great opportunity to join a dynamic, fast-growing $550M+ global agency!

This position is classified as non-exempt in accordance with the Fair Labor Standards Act (FLSA).

What you’ll do: 

• Process invoices and resolve client accounting/billing discrepancies with internal team and clients.
• Process purchase orders upon request.
• Manage and track accounts receivables statuses Participate in monthly financial review meetings with account teams (creation/review of budget trackers) and run financial queries as needed.
• Assist with client reporting, audit requests and data collection for assigned accounts as needed.
• Review monthly fee and expense details; pull back up documentation/files as needed to ensure proper coding of expenses.
• Reconcile charges within internal financial system
• Provide time and expense details incurred on assigned accounts to Project Managers.
• Support the department by maintaining files, contracts and other relevant documentation. 
• Complete assigned accounting/billing work as well as assist across the business when necessary.
• Liaise with and review work of our external billing team.

This position is a perfect fit for you if: 

• ​Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 
• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 
• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• Bachelor’s Degree in Accounting, Finance, or related field. 
• Intermediate to advanced knowledge of Microsoft Excel, including Pivot Tables and VLOOKUPs; interview may include virtual Excel test.
• Professional communication manner and ability to triage messages when appropriate.
• Ability to maintain security of confidential information/conversations that impact the business. 
• 3+ years’ experience in Billing Associate or Client Accounting Associate role; experience working in an Advertising or PR firm necessary.
• Experience with financial systems; familiarity with NetSuite a plus.

Pay Range: $50,000 - $60,000
his is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

About the Role

Iterative Health is redefining how clinical trials are conducted in IBD, and we’re looking for a commercial leader to help scale that impact. As Director of Life Sciences, you will drive the next chapter of Iterative Health’s growth in the biopharma and biotech ecosystem, owning and expanding relationships with our most important sponsors.

This is a high-visibility, client-facing role for a builder - someone who thrives on creating value in complex partnerships, influencing senior stakeholders, and driving outcomes that matter. You’ll be the connective tissue between sponsors and Iterative’s internal teams, ensuring we deliver on every commitment while shaping how we evolve our solutions to meet the future of clinical research.

This role is ideal for a relationship-driven commercial leader who thrives in high-growth environments and enjoys building deep, strategic partnerships in the life sciences space. 

Responsibilities

• Own Strategic Partnerships: Serve as the primary relationship lead for major biopharma and biotech sponsors — building trust, credibility, and alignment at senior and executive levels
• Drive Growth & Retention: Develop and execute account strategies that deepen partnerships, secure renewals, and expand engagement across studies, indications, and services
• Lead Account Strategy & Planning: Partner with cross-functional teams to forecast, analyze performance, and deliver joint business plans that unlock shared growth
• Ensure Operational Excellence: Work cross-functionally with internal teams (product, operations, clinical) on timelines, deliverables, and performance standards to consistently exceed sponsor expectations
• Shape Commercial Strategy: Translate sponsor insights into actionable recommendations that influence pricing, go-to-market approaches, and Iterative Health’s evolving value proposition
• Represent Iterative Health: Serve as a senior representative at industry conferences, sponsor forums, and advisory boards — positioning the company as a trusted, innovative partner in clinical research
• Monitor and Optimize Account Health: Track satisfaction and performance metrics to proactively address risks and surface new opportunities

What We’re Looking For

Required Qualifications

• 8–10+ years of experience in life sciences with a focus on enterprise account management, strategic partnerships and clinical trials.
• Proven success in managing and growing enterprise-level sponsor accounts in the biotech and biopharma space.
• Skilled in relationship management, executive-level communication, and strategic account planning.
• Strong track record of delivering against growth targets in a high-growth, fast-paced environment.
• Entrepreneurial mindset with a high level of ownership and accountability.
• Ability to collaborate effectively across internal functions and navigate cross-functional ambiguity.
  
  

Preferred Qualifications

• Deep understanding of the clinical trials and sponsor landscape.
• Prior managerial experience.
• Advanced degree in healthcare or business (MBA, MPH, PhD).

Linus Health is a Boston-based digital health company focused on transforming brain health for people across the world. By advancing how we detect and address cognitive and brain disorders – leveraging cutting-edge neuroscience, clinical expertise, and artificial intelligence – our goal is to enable a future where people can live longer, happier, and healthier lives with better brain health.

About The Role:

We are looking for a reliable, experienced, and task-oriented EA with a proven track record. The ideal candidate is highly self-motivated, professional, organized and capable of managing their workload and prioritizing tasks in a faced paced environment. The role is a "gatekeeper" to our CEO and a reflection of him both internally and externally. Additionally, you will be the first point of contact for everything that goes through the CEOs office. While we are 100% remote at the moment, we are looking for someone to be Boston / Greater Boston based to be able to meet with the CEO in-person. We may also have an office in the near future in which case we would ask this employee to come in 1-2 times a week to meet and support the CEO in person.

What You’ll Do:

• Completes a broad variety of professional and personal operational tasks for the CEO including managing an extremely active calendar of appointments; composing and preparing correspondence that are oftentimes confidential (eventually, after trust is built, responds on behalf of the executive); answers calls, arranges travel plans, itineraries, and agendas.
• Plans, coordinates and ensures the CEO's schedule is followed and respected. Provides "gatekeeper" and "gateway” role, creating win-win situations for direct access to the CEO's time.  
• Triage the barrage of information, challenges and background noise that the CEO is bombarded with (this will take time).
• Determine what the CEO needs to know and what he does not.  
• Oftentimes requests that come in may need action, just not from the CEO.
• It’s up to the executive assistant to determine how to best respond and redirect these requests so they are resolved without hitting his desk.
• Anticipate which requests will likely bubble up again or who may look for other routes to get to the CEO, so you can prepare him just in case.
• Anticipates the needs of the CEO and strives to provide services or products before being requested.
• Provides a bridge for smooth communication between the CEO's office and internal departments; demonstrating leadership to maintain credibility, trust and support with senior management staff.
• Works closely and effectively with the CEO to keep he/she well informed of upcoming commitments and responsibilities (both personal and professional), following up appropriately. Acts as a "barometer," having a sense for the issues taking place in the environment and keeping the CEO updated.
• Interacts professionally with executive assistants of other high level executives in other organizations.
• Prep for BOD meetings - once agenda is agreed upon, liaise with legal to prepare consent(s), solicit appropriate content from internal stakeholders for final review by CEO/COO/Legal..
• Successfully completes critical aspects of deliverables with a hands-on approach, including drafting personal correspondence, emails, and other tasks that facilitate the CEO's ability to effectively lead the company.
• Act as liaison for CEO between C-Suite and Senior Management.
• Maintains discretion and confidentiality in relationships.

About You:

• 10+ years in a similar EA type role supporting "C level executives
• Healthcare, Biotech, Pharma and/or digital health experience
• Ability to inspire trust and loyalty given the amount of exposure to confidential information
• Confidence in ability to act as a Gatekeeper on behalf of the CEO - proven ability to deter others who want direct access to CEO but perhaps the topic should be resolved by someone else
• Ability to pivot and adapt to changing circumstances
• Problem solving ability and organizational skills
• Excellent platform presentation skills, interpersonal skills, as well as excellent written and verbal communication skills. Politically savvy and an excellent communicator
• Results driven, detail oriented and demonstrated accountability
• Ability to work as part of a team and independently
• Ability to think strategically9one step ahead of the CEO) yet execute tactically
• Go-getter and results-driven attitude - a self-started with a lot of fire and grit

Compensation: Compensation: The base salary budgeted for this position is in the $90,000-115,000 range per year. This position will also include a yearly target discretionary bonus as well as equity, health benefits, unlimited PTO, a monthly flex day, a 401K plan with a match and more. The final offer determined for the candidate who is hired into this position will depend on a number of factors, including, but not limited to, the candidate's relevant skills, professional experience, labor market conditions, etc. 

Linus Health is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, religion, color, national origin, sexual orientation, gender, gender identity or expression, age, genetic information, disability or any characteristic protected by law. We believe that diversity is critical to the growth of our company and understand the importance of fostering an environment where everyone has a voice. We are also committed to providing reasonable accommodations for candidates with disabilities during the recruiting process. If you are in need of assistance due to a disability, please contact us.

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 >>> Senior Manager, Legal Operations & Contracts  

As the Senior Manager, Legal Operations & Contracts reporting to the Vice-President, Legal Counsel, you will bring strong legal operations expertise, including process management, execution, compliance, and process optimization, with a focus on building and scaling efficient workflows. In addition, you bring a deep background in drafting, reviewing, and negotiating a high volume of both routine and complex contracts. This role will operate independently across functions as a trusted partner, proactively managing the end-to-end contract lifecycle for commercialization contracts while driving operational excellence and efficiency. 

This role will support the legal team through KPI tracking, metrics, and analysis, while identifying and driving workflow efficiencies as the function scales. This role requires strong legal knowledge, the ability to work independently, and to build and maintain cross-functional relationships. The ideal candidate is detail-oriented, highly organized, and proficient with systems and tools, with a solid understanding of corporate contracts. Strong communication, collaboration, and time management skills are essential, along with a proactive, positive, and growth-oriented mindset. 

This role is based out of our San Francisco or Boston office and will require 10% travel. 

Your work will primarily encompass: 

• Manage legal operations activities including contributing to the development of training materials, documentation, and process improvements to support efficient contracting practices
• Lead and optimize legal operations processes such as contract management, document management, knowledge management, vendor relationships, and strategic processes
• Drive operational efficiencies through technology and process improvements, managing legal department projects, and support day-to-day operations
• Develop and implement policies and procedures to improve legal department effectiveness and efficiency
• Negotiate, draft, review, and manage a wide range of contracts. (including confidentiality agreements, SOWs, consulting and service agreements, materials transfer agreements, sponsored research agreements, clinical study agreements, and various vendor services agreements) with guidance from senior attorneys as needed
• Communicate with internal stakeholders regarding contractual risks and support development of practical mitigation approaches
• Ensure contractual terms and conditions are consistent with Olema policies, standards, and established guidance
• Ensure compliance with applicable laws and regulations, including data protection and privacy requirements (e.g., GDPR, HIPAA)
• Serve as an escalation point of contact for internal and external contract process/status questions and escalate more complex issues as appropriate 
• Manage contract workflow and support adherence to contract turnaround timelines to ensure efficient execution
• Support and partner in the development, enhancement, and maintenance of contract templates and SOPs
• Be the contract management systems expert (i.e. Agiloft)
• Coordinate with outside counsel and in-house legal team to obtain legal documents, e.g., patent declarations and assignments, and manage legal records

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, is required 
• Paralegal certificate or legal studies background preferred
• Demonstrated experience leading legal operations, including contract lifecycle management, process optimization, and implementation of tools and systems to improve efficiency
• Managing full contract lifecycle, including drafting, negotiating, editing, and execution, with a strong understanding of contract terms, structure, and end-to-end contract management processes (tracking, approval, and execution) 
• Knowledge or experience with paralegal support tasks, with a focus on compliance program matter, contract or corporate matters
• Working knowledge of the drug discovery and development process and ability to understand risks and requirements associated with pharmaceutical contracting preferred
• Proficiency with contract management software 

Experience: 

• A minimum of seven years (7+) of relevant experience in legal operations and contract management
• In-house experience at a biotechnology, pharmaceutical or life science company with a focus on legal operations and agreement drafting and negotiation, strongly preferred
• Demonstrated experience working with attorneys and senior leaders across various functions
• Ability to work both independently and effectively across a variety of functional groups (such as Commercial, Research and Development, CMC, Human Resources, Finance, Facilities and IT) and all levels of management
• Liaison and point of contact for business contract owners and vendor/agency inquiries related to contracting and payment in partnership with legal, finance, and procurement
• Strong technical skills (e.g., Microsoft Word, Excel and PowerPoint, Contract Management Systems, Docusign)

Attributes: 

• Highly organized, detail-oriented, and process driven 
• Proactive and solutions-oriented 
• Strong collaborator with the ability to influence cross-functional teams 
• Comfortable operating in a growing, fast-paced biotech environment 
• High level of integrity and discretion 
• Flexible and willing to learn new procedures and skill sets

The base pay range for this position is expected to be $150,000 - $170,000 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

We are looking for a Clinical Data Manager to join our Research Operations team, which drives the end-to-end execution of studies that drive new feature development and validation.  

In this role, you will be part of the full lifecycle of clinical study data — from database build and validation through database lock and archival — ensuring that data is compliant, traceable, and inspection-ready. You will also take a hands-on role in building data quality monitoring reports and dashboards using programming languages and analytics tools to provide real-time visibility into study health.

You’ll work closely with Clinical Operations, Regulatory, Biostatistics, Science, Data Engineering, and external vendors to ensure that our data management practices meet FDA, ICH-GCP, and internal quality standards while enabling speed and scalability.

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:

• Develop and maintain data quality monitoring frameworks, including defining key data quality metrics and thresholds
• Build and maintain quality dashboards and reports using programming languages (e.g., SQL, Python) and BI tools to provide near real-time study insights
• Oversee data validation, coding, reconciliation (e.g., safety, device, external vendor data), and risk-based review processes
  
• Ensure compliance with ICH-GCP, 21 CFR Part 11, HIPAA, and applicable FDA expectations for regulated SaMD trials
• Partner with Engineering and Data teams to support ingestion, transformation, and traceability of multi-source clinical datasets (e.g., wearable data, ePRO, device integrations, CRO exports)
• Manage CRO and vendor data management deliverables, ensuring sponsor oversight and quality standards are met
• Identify data-related risks early and drive mitigation strategies
• Contribute to SOP development and help standardize scalable, repeatable data management practices across Research Operations

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

• 3+ years of industry experience in clinical data management within medical device, digital health (SaMD), biotech, or CRO environments
• Experience supporting regulated clinical trials and regulatory submissions (e.g., 510(k), De Novo, CE/MDR)
• Hands-on experience with industry-standard EDC systems (e.g., Medrio, REDCap, Rave, TrialKit)
• Strong working knowledge of ICH-GCP, 21 CFR Part 11, and data privacy regulations
• Experience managing database builds, edit checks, UAT, query resolution, and database lock activities
• Proficiency in SQL and/or Python, with demonstrated experience building data quality reports, dashboards, and validation queries
• Experience working with structured clinical datasets and familiarity with CDISC standards (SDTM/ADaM) preferred
• Experience collaborating cross-functionally with Clinical Operations, Biostatistics, Regulatory, Engineering, and CRO partners
• Comfort operating in a fast-paced, product-driven environment with multiple concurrent studies
• Flexibility with scheduling to support global collaborators when needed

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 $151,300 - $178,000
• Region 2 $138,550 - $163,000
• Region 3 $127,500 - $150,000

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)

POSITION OVERVIEW:

The Vice President, Regulatory Partnerships is a senior leadership role within the end-to-end Regulatory Strategy organization, spanning preclinical, clinical, Regulatory CMC, Regulatory Operations, and Regulatory Partnerships. This role is responsible for leading and expanding strategic regulatory partnerships, with a strong emphasis on post-approval lifecycle management, driving integrated client solutions, and accelerating commercial growth.

This leader will play a pivotal role in shaping how regulatory services are delivered across the organization by connecting scientific expertise with strategic advisory and execution, while positioning the company as a trusted partner to global pharmaceutical and biotech clients. A key focus of the role will be optimizing post-approval strategies, enhancing client delivery models, driving efficiencies, and embedding continuous improvement across engagements.

KEY RESPONSIBILITIES:

Strategic Leadership and Organizational Impact

• Lead the Regulatory Partnerships function as a core component of an integrated, end-to-end Regulatory Strategy organization
• Define and execute the strategic direction for partnerships, including post-approval and lifecycle management capabilities, ensuring alignment with broader business goals
• Build, lead, and develop a high-performing global team across the United States, India, and evaluate entry into Europe
• Partner across Regulatory Consulting, Regulatory CMC, Regulatory Operations, and other service lines to deliver seamless, client-centric solutions
• Builds a culture of rigor and accountability by establishing clear performance metrics, KPIs, and standardized processes across regulatory partnerships, enabling consistent measurement of delivery quality, efficiency, and client outcomes.

Commercial and Business Acumen

• Drive revenue growth through expansion of strategic client partnerships and development of new business opportunities, including post-approval lifecycle services
• Act as a commercial leader, contributing to pipeline development, account strategy, and revenue forecasting, in consultation with the Commercial team
• Collaborate with Commercial and Business Development teams to shape go-to-market strategies and differentiated service offerings
• Identify opportunities to expand client engagements through lifecycle management, regulatory optimization, and long-term partnership models
• Monitor industry trends, competitive landscape, and evolving regulatory requirements to inform growth strategy

Client Leadership and Partnership Excellence

• Serve as an executive sponsor for key global client relationships
• Lead and manage strategic client partnerships with a focus on long-term lifecycle support, including post-approval activities (variations, supplements, global submissions)
• Build and sustain value-driven relationships with senior client stakeholders across regions
• Ensure consistent, high-quality delivery across engagements, with a focus on scalability, predictability, and client satisfaction
• Leverage client insights and engagement learnings to continuously refine delivery models and strengthen partnerships

Operational Excellence, Efficiencies, and Continuous Improvement

• Drive operational efficiencies by standardizing processes, tools, and delivery models across regulatory partnerships
• Capture and implement learnings from client engagements to enhance quality, consistency, and speed of delivery
• Establish best practices for global post-approval lifecycle management and submission strategies
• Partner with internal teams to optimize resource models, utilization, and delivery effectiveness
• Embed a culture of continuous improvement, innovation, and knowledge sharing
• Leverages data and insights to drive decision-making, continuously refine delivery models, and ensure transparency and alignment across global teams.

Technical and Functional Expertise

• Provide deep expertise across global regulatory frameworks, including FDA, EMA, and other international health authorities, with a strong focus on post-approval requirements
• Guide teams on complex regulatory strategies across the full product lifecycle
• Maintain oversight of quality, compliance, and consistency across all client deliverables
• Contribute to thought leadership, innovation, and advancement of regulatory strategy capabilities

Global Leadership and Cultural Agility

• Lead and develop globally distributed teams, with direct experience across the United States, India, and Europe
• Demonstrate strong cultural awareness and adaptability, enabling effective collaboration across diverse teams and client environments
• Navigate the complexities of global client delivery, recognizing that client partnerships span multiple regions, regulatory bodies, and cultural contexts
• Align global teams to shared goals while respecting regional differences in communication, decision-making, and execution
• Evaluate and, if needed, support expansion into European markets, with an understanding of regional regulatory dynamics and business opportunities
• Foster an inclusive, high-performance culture that promotes accountability, engagement, and excellence across geographies

QUALIFICATIONS & EXPERIENCE:

Education

• Bachelor’s or Master’s degree in Biology, Chemistry, or a related scientific field required

Experience

• 15+ years of progressive experience in Regulatory Affairs, including significant experience in post-approval and lifecycle management
• Demonstrated experience working with the U.S. Food and Drug Administration and strong knowledge of European regulatory frameworks
• Proven experience working within both large pharmaceutical organizations and scientific consulting environments
• Track record of leading and scaling global teams across the United States, India, and Europe
• Strong commercial acumen with demonstrated success in driving revenue growth and expanding client accounts
• Experience leading complex global client engagements and managing senior stakeholder relationships
• Demonstrated ability to drive operational efficiencies, standardization, and continuous improvement
• Experience supporting or leading global regulatory partnership models or FSP-style engagements preferred

Leadership Profile

• Strategic, enterprise thinker with the ability to connect regulatory expertise to business growth
• Commercially driven with strong business and financial acumen
• Client-focused leader who builds trusted advisor relationships
• Collaborative operator who thrives in a matrixed, global organization
• Proven people leader with the ability to develop, inspire, and retain high-performing teams
• Highly adaptable, with strong executive presence and ability to influence across all levels of the organization

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

Our Opportunity…

We are looking for a strategic and hands-on Associate Director, IT Operations to lead and optimize Digital Solutions & Technology operations at Obsidian, delivering secure, compliant, and scalable technology services that enable our clinical-stage biotech teams to achieve breakthrough scientific and business outcomes.

You Will...

• Develop and execute Digital Solutions & Technology operations strategy aligned with Obsidian’s growth, compliance needs, and culture. 
• Lead day-to-day operations, including infrastructure, cloud environments, enterprise systems, and lab/scientific software. 
• Manage MSP resources, ensuring high-quality support and service levels. 
• Partner with Info Security lead to ensure robust cybersecurity and data protection. 
• Optimize Digital Solutions & Technology processes (incident, problem, change management) and drive adoption of best practices, with a strong emphasis on ITIL and change management in a controlled, regulated environment. 
• Manage vendor relationships and operations budget. 
• Support onboarding/offboarding, access management, and end-user training. 
• Foster a culture of accountability, collaboration, and continuous improvement. 
• Risk Management & Business Continuity: Identify, assess, and mitigate IT risks; develop and maintain business continuity and disaster recovery plans. 
• Work closely with Facilities, Lab Operations, and other business units to ensure Digital Solutions meet evolving scientific and operational needs. 
• Continuous Improvement & Innovation: Drive process optimization and adoption of new technologies to improve service delivery and operational efficiency. 
• KPIs & Metrics: Define, track, and report on IT operational KPIs (e.g., uptime, ticket resolution, user satisfaction, compliance metrics). 
• Regulatory Audit Readiness: Prepare for and support regulatory audits (FDA, SOX, etc.), ensuring documentation and processes are audit-ready. 

Key Systems & Platforms 

• Networking: Cisco Meraki, Fortinet 
• Scientific/Lab: Benchling, Egnyte 
• HR: ADP, Greenhouse, Pave 
• Finance: NetSuite, FloQast, Concur 
• Business Development: DataSite DataRooms 
• Enterprise: M365, Adobe, Teams, Teams Room Systems 
• Ticketing: Freshdesk 
• Compliance: ComplianceWire, validated SharePoint 

 You Bring...

Core Qualifications

• Bachelor's degree in computer science, Information Technology, or related field with 10+ years of relevant IT experience, including leadership of IT operations in a regulated environment (biotech, pharma, or healthcare preferred). 
• Experience with IT operations in agile, fast-growing companies. 
• Experience with GxP systems operational support (CSV/CSA). 
• Experience with change control systems and processes for GxP/SOX. 
• Experience managing MSPs and IT service delivery across multiple locations. 
• Strong knowledge of enterprise platforms (NetSuite, M365, ADP, Benchling, etc.) and lab/scientific software. 
• Experience managing Lab IT systems 
• Excellent planning, coordination, and time management skills. 
• Strong oral, written, and visual communication skills. 
• Ability to build productive relationships across scientific, business, and technical teams. 
• Systems thinking and sound judgment, especially in risk management and escalation 
• Collaborative and accountable – recognizes success requires teamwork and interdisciplinary thinking; shares feedback and ideas to facilitate better outcomes 
• Self-motivated, with a proven ability to meet objectives and timelines, managing multiple responsibilities in parallel.   
• Flexible - adapts to change in a fast paced, rapidly developing environment 
• Curious and humble – seeks and welcomes input/expertise of others, continuous learner 
• Tenacious and resilient – is not easily overwhelmed by challenges, delivers on commitments  

POSITION OVERVIEW:
We are seeking a Sr. Fill–Finish Process Engineer with strong experience in aseptic pharmaceutical or biologics manufacturing to support the capital project buildout of a new fill–finish suite within a commercial manufacturing facility. The ideal candidate has hands-on expertise in formulation, sterile filtration, aseptic filling, lyophilization, capping, inspection processes, and associated equipment technologies, along with a strong understanding of GMP operations and regulatory expectations. This position partners closely with operations, QA, validation, MS\&T, engineering, and supply chain to ensure robust, compliant, and continuously improving manufacturing performance.

WORK LOCATION:
Travel to client sites may be required up to 100% based on project phase and client needs.

KEY RESPONSIBILITIES:
(This list is not exhaustive and may be adjusted as needed.)

• Support design, construction, installation, and qualification of a new commercial fill–finish suite, including cleanrooms, process utilities, and supporting infrastructure.
• Contribute to user requirement development, equipment specifications, vendor evaluations, and design reviews.
• Support FAT/SAT, commissioning, and qualification activities for fillers, isolators or RABS, lyophilizers, depyrogenation tunnels, autoclaves, CIP/SIP systems, formulation vessels, sterile filtration skids, and inspection machines.
• Conduct field walkdowns, verify installation details, and ensure alignment with drawings, P\&IDs, and GMP requirements.
• Serve as subject matter expert for fill–finish operations including formulation, filtration, filling, lyophilization, capping, and visual inspection.
• Partner with Operations and MS\&T to troubleshoot and resolve technical issues.
• Collaborate with Maintenance and Reliability teams to address equipment performance gaps.
• Support continuous improvement and process optimization initiatives.
• Partner with QA, Validation, and MS\&T to maintain validated state of aseptic manufacturing processes.
• Ensure alignment with regulatory requirements including FDA, EMA, ICH, and Annex 1.
• Support continued process verification (CPV), annual product review (APR/PQR), and ongoing process monitoring.
• Author, review, and approve GMP documentation, including batch records, SOPs, change controls, CAPAs, deviations, and technical reports.
• Generate and maintain engineering lifecycle documentation including impact assessments, URS/FRS documents, FAT/SAT packages, and turnover packages.
• Develop and execute commissioning and qualification protocols.
• Utilize systems such as building management systems, process control systems, and computerized maintenance management systems. Experience with digital validation platforms such as KNEAT is a plus.
• Ensure all work complies with GMP standards, safety expectations, and regulatory guidelines
• Coordinate across engineering, operations, facilities, quality, and validation to ensure successful project execution.
• Participate in project planning, scheduling, risk assessments, and milestone tracking.
• Provide effective communication to stakeholders at all levels.

QUALIFICATIONS AND REQUIREMENTS:

Education

• Bachelor’s or Master’s degree in Chemical, Mechanical, Biomedical, Pharmaceutical Engineering or a related technical field.

Experience

• Typically 7 or more years of experience in GMP pharmaceutical or biotech manufacturing.
• Strong preference for sterile, aseptic, biologics, or vaccine fill–finish experience.
• Experience supporting commercial manufacturing operations in a regulated environment.
• Experience with commissioning, qualification, and engineering documentation.

Knowledge, Skills, and Abilities

• Strong understanding of aseptic operations, cleanroom environments, and fill–finish equipment.
• Strong documentation and technical writing skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong communication, analytical, and problem-solving skills.
• Ability to work independently and collaboratively.

ESSENTIAL FUNCTIONS:

Physical Demands: 

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus. 

Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment. 

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company-paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere.” However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time. 

LEGAL STATEMENT:
 
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer. 

Real Chemistry is looking for an Associate Creative Director, Art to join our growing team!  

21GRAMS, a Real Chemistry subsidiary is an advertising agency born to make healthcare more human. Not just in our work, but in the way we conduct business, approach client relationships, and treat each other. It’s a place where people subscribe to the adage, “Be good to each other, but hard on the work.” A place where people are not just in it for the paycheck, but to make a dent in the universe. Sound like you? 

21GRAMS is looking for an Associate Creative Director, Art. A brand steward and category champion, responsible for having a deep understanding of the brand, its benefits, and driven distinction. With a drive for creativity and purpose. With a hands on approach to leadership and team building. 

This is a hybrid role, based in any of our US offices—including New York City, Boston, Chicago, Carmel, or San Francisco—or remotely within the US, depending on team and business needs.

What you’ll do: 

• Responsible for art direction and design across a variety of tactics 

• Convey scientific information into compelling and memorable messages campaigns 

• Champion creative thinking for campaigns and initiatives that advance creative strategy and brand personality 

• Deployment, and partner with Account and Strategy teams at all points 

• Ability to independently lead multiple projects, sometimes for different brands/industries 

• Clearly and confidently present work to clients and internal team members 

• Review and complete employee performance feedback  

• Build a working relationship between the business and clients  

• Work closely with art/design, tech, editorial, and project management departments to ensure that deadlines and budgets are met  

• Assign creative teams best suited for each project based on ability and workload 

• Identify and interview prospective creative candidates  

This position is a perfect fit for you if: 

• Our Company values – Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” – really speak to you. 

• You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We’re always evolving. 

• You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. 

• You are highly organized self-starter, able to work independently and under tight deadlines. 

What you should have:  

• 10+ years healthcare/pharmaceutical art direction and design 

• Experience in the healthcare/pharmaceutical industry in an agency setting required 

• Portfolio or PDF of relevant work samples required 

• Must have Oncology experience

Pay Range: $165,000 – $180,000
This is the pay range the Company believes it will pay for this position at the time of this posting.  Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time.

About the Role >>> Vice President, Quality Assurance  

The Vice President, Quality Assurance serves as the senior leader accountable for defining and driving Olema’s global quality strategy, systems, and governance across the full product lifecycle, including clinical development, manufacturing, pharmacovigilance, and commercial. This leader is the primary voice of Quality at the executive level and ensures a phase-appropriate, risk-based approach to quality that reflects the needs of oncology drug development, where patient safety, data integrity, and speed are critical.  

Operating with appropriate independence, this role partners cross-functionally and leads an established Quality leadership team across GCP, GMP, and GPV - aligning priorities, strengthening execution, and ensuring inspection readiness as Olema advances toward late-stage development.

This role is based out of our either our San Francisco, CA or Boston, MA office and will require some travel as needed.  

As Vice President, Quality Assurance, your work will primarily encompass:

Quality Strategy & Leadership  

• Define and drive a pragmatic, phase-appropriate and unified Quality strategy aligned with Olema’s pipeline and corporate objectives   
• Serve as the senior Quality leader, establishing clear governance, decision-making frameworks, and escalation pathways   
• Lead and develop Quality leadership across GCP, GMP, and GPV, enabling strong execution and maintaining clear accountability   
• Foster a culture of quality, integrity, and patient focus across the organization   
• Act as escalation point for significant quality, compliance, and patient safety risks   
• Ensure ongoing inspection readiness across clinical, manufacturing, and safety domains 

Quality Systems & Governance  

• Set expectations and direction for a scalable, integrated, and sustainable Quality Management framework spanning clinical through commercial stages   
• Ensure effectiveness and evolution of Quality systems through oversight of functional leaders across the QA function   
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization   
• Establish clear quality metrics and reporting to enable risk visibility and informed decision-making 

Clinical Quality (GCP)  

• Ensure Quality approaches appropriately support the execution of oncology clinical trials   
• Provide oversight of clinical quality and CRO management to ensure patient safety and data integrity   
• Partner with Clinical and Regulatory to support inspection-ready programs and submissions

Manufacturing & Commercial Readiness (GMP)  

• Ensure Quality strategy supports manufacturing scale-up and readiness for late-stage development and commercialization   
• Oversee GMP Quality through established leadership, ensuring appropriate CMO/CDMO oversight and inspection preparedness   
• Provide Quality input into CMC, validation, and supply chain readiness activities

Pharmacovigilance Quality (GPV)  

• Oversee the pharmacovigilance quality framework, ensuring compliance, data integrity, and effective safety surveillance   
• Ensure PV systems and vendors are appropriately governed and inspection-ready   
• Partner cross-functionally to support ongoing evaluation of benefit-risk

Inspection, Audit & Risk Management  

• Lead the Company’s approach to regulatory inspections, including preparation and execution   
• Ensure risk-based audit programs across GCP, GMP, and GPV   
• Drive proactive identification and mitigation of quality and compliance risks

Cross-Functional Leadership  

• Partner with Executive Leadership, Regulatory, Clinical, and Manufacturing, to embed quality across the organization   
• Provide clear, actionable Quality perspectives to support business decisions   
• Represent Quality in executive discussions and external engagements as needed   

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

• Advanced degree in Life Sciences or related discipline (PhD, PharmD, MS) 
• Deep knowledge of FDA, EMA, ICH, and global GxP and pharmacovigilance (GPV) regulatory requirement 
• Expertise across GCP, GMP, and GPV Quality domains 
• Strong understanding of Quality systems, governance, and inspection readiness practices 
• Working knowledge of oncology drug development

Experience

• Minimum of 15+ years of Quality experience in biotech/pharma with increasing scope and responsibility 
• Significant people management and leadership experience, including leading senior team members 
• Experience overseeing global vendor networks, including CROs, CMOs, CDMOs, and PV vendors 
• Demonstrated experience across GCP, GMP, and GPV environments 
• Proven track record supporting programs from clinical development through late-stage or commercial readiness 
• Experience leading regulatory inspections and interacting with global health authorities 
• Experience implementing and maintaining Quality systems and compliance frameworks

Attributes

• Strong leadership capability with ability to lead through and develop senior leaders 
• Effective communicator with executive presence and influencing skills 
• Sound judgment and decision-making in complex, risk-based environments 
• Ability to operate effectively in a fast-paced, evolving biotech environment 
• Commitment to quality, compliance, and patient safety 

The base pay range for this position is expected to be $315,000 - $340,000 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. 

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