Senior Medical Director, Global Drug Safety Replimune Group IncSenior Medical Director, Global Drug SafetyWoburn, MA$307,000–$397,000 / yearThis position provides pharmacovigilance expertise to and lead collaborations with external partners as well as with other functions across Replimune, including Regulatory Affairs, Clinical Development, Clinical Operations, Medical Affairs, or the Commercial to ensure that drug safety communications are accurate, complete and consistent. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response.
Key Accounts Director (Boston) Summit TherapeuticsKey Accounts Director (Boston)Boston, Massachusetts$205,000–$240,000 / yearThe Key Account Director will develop and execute strategic account plans designed to support rapid product adoption through clinical pathway and treatment protocol inclusion, while representing Summit Therapeutics with key executive decision-makers across key oncology accounts (IDNs, Academic Centers, regional health systems, and community network parent organizations). Build and sustain strong multi-level relationships with healthcare decision-makers, including P&T and formulary committee members, executive pharmacy leadership, C-suite executives, and service line leaders, across key oncology accounts (IDNs, Academic Centers, regional health systems, and community network parent organizations).
Associate Director, Medical Writing AlkermesAssociate Director, Medical WritingWaltham, MARemote$175,000–$190,000 / yearThe Associate Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Director, Medical Writing AlkermesDirector, Medical WritingWaltham, MARemote$220,000–$235,000 / yearThe Director is accountable for document development strategy, planning, and execution; leads clinical content development for complex submissions (including content strategy, organization, and resourcing); and partners with Clinical Development, Regulatory Affairs, Biostatistics, and other key functions to ensure cohesive messaging, mitigate risk, and support successful regulatory interactions and filings. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Senior Director, Drug Product CMC Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and CompanySenior Director, Drug Product CMCBoston, MA$160,000–$250,000 / yearReporting to the Executive Director, CMC, this position will primarily lead work with external vendors and oversee nonclinical formulation development, with flexibility to support clinical drug product development, across programs to meet company deliverables and timelines. Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders.
Associate Director, Regulatory Strategy Alpha-9 Oncology IncAssociate Director, Regulatory StrategyBoston, MAReporting to the Vice President, Regulatory Affairs, this individual will help shape and execute global regulatory strategy, lead submission planning and execution, and support interactions with health authorities across our programs. This is a hands-on role with the opportunity to work closely with leadership and cross-functional teams while helping build the processes and capabilities that will support the continued growth of the Regulatory Affairs function.
Therapeutic Area Biomarker Director - Cardiovascular and Metabolism Novartis AGTherapeutic Area Biomarker Director - Cardiovascular and MetabolismCambridge, MA$185,500–$265,000 / yeargenetics, inflammation, imaging depending on background and expertise• Stay up to date on clinical, disease, biology and scientific literature and competitor data for their respective disease areas• Implementing strategies in close collaboration with the BMD global organization which includes over 150 associates with expertise in all aspects of biomarker science i.e. genetics, genomics, molecular and cellular, digital devices, imaging and data sciences• Design and present the RDC biomarker strategy for transitioning and mature assets for late phase within their key pillar and ensuring study level alignment across the portfolio segment of focus Essential Requirements: • MD, MD/PhD, or PhD degree required, plus additional PhD/postdoc or equivalent level research • Deep understanding of cardiovascular and metabolic disease epidemiology with particular emphasis on Atherosclerotic Cardiovascular Disease (ASCVD) that can be applied to questions of diagnosis, biomarker development and treatment monitoring strongly preferred• Scientific excellence supported by recognized high quality publications; clinical and/or biological expertise in cardiovascular and metabolic diseases (Board certified or similar level preferred) with impact in ASCVD literature• 5 plus years of independent leadership experience and external leadership/partnership in consortia and/or health authority initiatives• Proven success in leading and partnering in multidisciplinary matrix teams across Pharma/biotech (clinical research thru healthcare applications), academic institutions, or commercial business functions including a mature biomarker strategy to support registration and/or launch • Demonstrated ability to own an entire section of the portfolio as well as the phase package; Well-developed interpersonal skills with good presence and ability to influence and negotiate with senior leadership; experienced presenter and communicator• Significant relevant experience after your MD/PhD/postdoc including quantitative expertise in biostatistics, bioinformatics, computer biology, statistical genetics, clinical imaging, machine learning, or data science; interpreting and publishing studies consisting of "omics" data e.g. For Switzerland posting please refer to REQ-10086998 Therapeutic Area Biomarker Director - Cardiovascular and MetabolismKey Responsibilities: • Delivering clinical project and disease biomarker strategies and plans across the early through late phase within the Cardiovascular and Metabolism portfolio and support relevant mature assets in the late phase portfolio• Leading a dedicated matrixed group of Subject Matter Experts and project team representatives as well as key program stakeholders, to together develop biomarkers strategies for disease and/or assets across the Research-Development-Commercial continuum• Representing Biomarker Development on Cardiovascular and Metabolism early and late Disease Area Decision Boards to identify, develop, and drive cardiovascular and metabolic disease and compound mechanistic biology, and precision medicine approaches for the portfolio • Leading strategic translational data working groups centered on integrating and analyzing large-scale patient muti-modal data sets (omics, imaging, digital, etc.) to identify new indications, endpoints, and responsive patient subpopulations• Representing BMD line functions in Therapeutic Area Line Function committees for clinical protocol development and operational milestone reviews• Leading biomarker strategies and drive plans at the clinical team level as a Biomarker Strategy Lead• Lead and/or contribute to BMD/TM/BR wide initiatives e.g.
Director, Regulatory Writing Entrada Therapeutics IncDirector, Regulatory WritingBoston, MARemote$220,000–$249,711 / yearReporting to the Senior Vice President, Regulatory Affairs, the successful candidate will support the development of strong internal processes, be the key liaison with external writing providers, serve as a lead author and document specialist, and support documentation planning and submission activities. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51).
Medical Director, Global Drug Safety Replimune Group IncMedical Director, Global Drug SafetyWoburn, MA$257,500–$333,500 / yearThe RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. Replimune's mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient's lives depend on it.
NewRadiation Oncology Field Medical Director EvolentRadiation Oncology Field Medical DirectorBoston, MA$130–$145 / hourNot under current exclusion or sanction by any state or federal health care program, including Medicare or Medicaid, and is not identified as an “excluded person” by the Office of Inspector General of the Department of Health and Human Services or the General Service Administration (GSA), or reprimanded or sanctioned by Medicare. What You Will Be Doing: Serve as the Physician match reviewer in Radiation Oncology and imaging cases, that do not initially meet the applicable medical necessity guidelines, as well as other imaging requests when providers, clients, or state laws require specialty reviews to be completed by the subject matter expert.
Director, Global Medical Lead, Zasocitinib - Psoriatic Arthritis (PsA) Takeda Pharmaceutical Co LtdDirector, Global Medical Lead, Zasocitinib - Psoriatic Arthritis (PsA)Cambridge, MA$192,400–$302,390 / yearLead and influence a global, cross-functional medical matrix across Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, Health Economics and Outcomes Research (HEOR), Digital/Data & Technology (DD&T), regions, and affiliates to ensure medical leadership is embedded in key product decisions. Provide Director-level medical leadership and strategic counsel to the GPT, GMUH, Rheumatology, and senior cross-functional stakeholders on product profile, data interpretation, benefit-risk, evidence gaps, and external scientific dynamics.
Associate Director, Global Biomarker Lead, Inflammation, GI2 TAU Takeda Pharmaceutical Co LtdAssociate Director, Global Biomarker Lead, Inflammation, GI2 TAUBoston, MA$154,400–$242,550 / yearLead the Translational Sub-Team (TST) and provide matrix leadership across multiple functional areas, working closely with physician scientists, clinical leads, clinical pharmacologists, TBB, nonclinical scientists, and discovery research scientists to build consensus around a fit-for-purpose biomarker strategy. The role is responsible for independently developing translational biomarker plans as part of the overall asset strategy across Discovery and Global Product Teams, supporting programs through clinical development and post-market activities, and ensuring timely delivery of high-quality biomarker data.
Associate Director/Director Drug Product, CMC Dianthus Therapeutics IncAssociate Director/Director Drug Product, CMCCambridge, MAOur second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation - enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. This role heavily centers on a solid understanding of Protein Chemistry, optimizing formulation and process parameters, overcoming shear stress and aggregation, and advancing prefilled syringe (PFS) and combination product delivery systems from late-stage clinical development, process performance qualification through commercial launch.
Director, Site Performance & Strategy - Cardiology Iterative Scopes IncDirector, Site Performance & Strategy - CardiologyCambridge, MA$170,000–$215,000 / yearIf you''ve spent years building frameworks for other people''s businesses in consulting, or running ops at a startup where you had to build the plane while flying it, this is where that skill set gets applied to a mission that matters: accelerating clinical trials that bring new treatments to patients faster. Serving as the operational owner of our centralized site solutions-including pre-screening, regulatory support, and eSource-you will partner cross-functionally to optimize workflows, scale capabilities, and improve site and sponsor outcomes.
Director, Medical Writing Dyne Therapeutics IncDirector, Medical WritingCambridge, MA$190,000–$235,000 / yearThis role partners closely with Clinical Development, Clinical Operations, Clinical Pharmacology, Regulatory Affairs, Research, Preclinical, Translational Biomarkers, Program Management, and Medical Affairs to ensure clear, consistent scientific messaging across key submissions to the FDA and global health authorities. Author, edit, and collaborate with cross-functional team members on key documents, including protocols, investigator brochures, clinical study reports, CTD modules, briefing books, and related submission materials.
Senior Director, US Patient Marketing Xenon PharmaceuticalsSenior Director, US Patient MarketingNeedham, MassachusettsThe Senior Director will build and lead a high‑performing Patient Marketing team and partner closely with Patient Services, Advocacy, Medical Affairs, Market Access, Legal, Regulatory, and Commercial leadership to ensure alignment, execution excellence, and meaningful impact for patients and caregivers. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Associate Director, Global Scientific Communications Bicara TherapeuticsAssociate Director, Global Scientific CommunicationsBoston, MassachusettsFICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF--driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF- ligand trap.
NewAssociate Director, CMC, Drug Substance Xenon PharmaceuticalsAssociate Director, CMC, Drug SubstanceNeedham, MassachusettsOur Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions. Our Phase 3 epilepsy program also includes a second FOS study, X-TOLE3, which would support regulatory submissions outside the U.S., and the X-ACKT study in primary generalized tonic-clonic seizures, which would support regulatory submissions for an additional epilepsy indication.
Director, Physician Researcher - Evidence Generation & Registries Verily Life Sciences LLCDirector, Physician Researcher - Evidence Generation & RegistriesBoston, MAActing as a primary customer-facing expert, this leader will partner with health systems, academic investigators, payers, and pharmaceutical and other industry partners to design rigorous, operationally feasible studies and registries that demonstrate the clinical, operational, and population-level impact of products and programs. The ideal candidate combines deep clinical judgment, methodological fluency in observational and real-world evidence research, and the interpersonal skill to build trust with external partners while advancing Verily's scientific and business priorities.
Global Medical Director, Medical Affairs Dyne Therapeutics IncGlobal Medical Director, Medical AffairsWaltham, MA$215,000–$260,000 / yearThis individual translates clinical and scientific insights into actionable medical strategies, supports congress, symposia, advisory board, publication, medical education, and evidence generation activities, and helps strengthen Dyne's external scientific presence with healthcare professionals, key opinion leaders, payers, patient communities, and other stakeholders. The Global Medical Director partners closely with Clinical Development, Clinical Operations, Regulatory Affairs, Scientific and Medical Communications, Value and Access, Commercial, Patient Advocacy, regional medical teams, and external experts to ensure medical plans are aligned with corporate, program, product, and regional priorities.