Director, Data Management Operational Excellence Moderna IncDirector, Data Management Operational ExcellenceCambridge, MA$167,000–$300,700 / yearWe are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. As a senior leader within Data Management, the Director translates portfolio strategy into operational execution frameworks, proactively mitigates regulatory and operational risk, and ensures sustainable inspection readiness through robust oversight, metrics, and process harmonization.
Senior Director, Quality Assurance, Commercial Xenon PharmaceuticalsSenior Director, Quality Assurance, CommercialNeedham, 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. We are seeking a Senior Director, Quality Assurance, Commercial as an integral leader within the Quality GMP team as well as a key member of highly collaborative R&D Operations group comprised of Program Management, CMC, Regulatory Affairs, Supply Chain and Quality functions.
Sr. Director, Regulatory Affairs Third Rock VenturesSr. Director, Regulatory AffairsCambridge, MA$245,000–$300,000 / yearThis individual will serve as a key cross-functional leader and regulatory expert, partnering closely with Program Leadership & Management, Clinical Development, Clinical Pharmacology, Clinical Operations, Biostatistics, Pharmacovigilance, CMC, Nonclinical, Quality, and Executive Leadership to advance innovative therapeutics through development and key regulatory milestones. We specifically target pathogenic antibodies and their cellular sources with bespoke Fc biotherapeutics engineered to selectively and completely eliminate the root causes of autoimmune and allergic diseases, and to achieve deep, durable responses while preserving essential immunity.
Associate Director, Formulation and Drug Product Development Dyne Therapeutics IncAssociate Director, Formulation and Drug Product DevelopmentWaltham, MA$159,000–$195,000 / yearThis role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne's strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials. Role Summary: The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne's bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability.
Director/Senior Director, Nonclinical Safety Toxicology Nimbus Therapeutics LLCDirector/Senior Director, Nonclinical Safety ToxicologyBoston, MA$225,000–$285,000 / yearManage nonclinical safety studies conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, review of data and draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities. Collaborate with CMC, Program & Portfolio Management, Clinical, Medical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND/CTA filing, and clinical development of new small molecule drug entities.
Senior Manager/Associate Director, Quality Assurance, GCP Xenon PharmaceuticalsSenior Manager/Associate Director, Quality Assurance, GCPNeedham, 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. Provide GLP/GCP compliance interpretation, consultation, training, root cause analysis, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to safeguard study participants’ safety and rights and ensure the quality, integrity, and credibility of data generated.
Global Medical Affairs Lead, PDT Immunology (Director) Takeda Pharmaceutical Co LtdGlobal Medical Affairs Lead, PDT Immunology (Director)Cambridge, MA$192,400–$302,390 / yearDesirable: Demonstrated curiosity and working knowledge of artificial intelligence, digital health, real-world evidence, data analytics, device innovation, and other technology-enabled advances that can improve medical decision-making, education, and patient outcomes. Support design and execution of designated evidence generation led by Medical Affairs, including Phase IIIb/IV studies, disease registries, observational studies, and noninterventional research, in collaboration with Therapeutic Area Unit representatives and Global Clinical Operations.
Associate Director, CMC, Drug Product Xenon PharmaceuticalsAssociate Director, CMC, Drug ProductNeedham, 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, Business Development - Life Sciences Arcadia Solutions LLCDirector, Business Development - Life SciencesBoston, MA$180,000–$220,000 / yearThis role is designed for a life sciences seller with fluency in real-world data, analytics, and evidence-based solutions-someone who understands how pharma organizations buy across the development lifecycle and who wants to build a durable book of business inside Arcadia's growing direct Life Sciences sales organization. Proactively build pipeline in a green-field or assigned Life Sciences territory using conference presence, publication monitoring, thought leadership networks, hunting via warm and cold outreach, leveraging of BDR Team, and CRO or consultancy partnerships.
Senior Director, Medical Affairs Editas Medicine IncSenior Director, Medical AffairsCambridge, MADecoding The Role: The primary focus of this role is to lead medical and scientific strategic planning and operational execution of core medical affairs activities from early-clinical phase through lifecycle management for our lead in vivo development candidate, EDIT-401, a potential best-in-class, one-time therapy designed to significantly reduce LDL cholesterol levels. This role will build Medical Affairs capabilities while providing scientific leadership and strategic direction across cross-functional teams and strong engagement with external stakeholders.
Associate Director, CMC, Analytical Development Xenon PharmaceuticalsAssociate Director, CMC, Analytical DevelopmentNeedham, 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. Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products, both internally and across Xenon’s network of CDMOs.
NewDirector, Corporate Strategy Flagship Pioneering IncDirector, Corporate StrategyCambridge, MA$183,000–$231,000 / yearThey will improve the quality and speed of Vesalius''s most important decisions, identify and advance high-value partnerships, strengthen the company''s investor narrative and engagement, raise the quality of executive and Board materials, and ensure that strategic priorities translate into coordinated action and measurable progress. This individual will work closely with senior leadership and cross-functional teams to translate scientific, clinical, competitive, and financial information into clear strategic choices, compelling external narratives, and coordinated action.
Director, Regulatory Writing Entrada TherapeuticsDirector, Regulatory WritingBoston, MassachusettsRemote$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).
Senior Director, Medical Affairs Learning & Development Dyne Therapeutics IncSenior Director, Medical Affairs Learning & DevelopmentWaltham, MA$245,000–$270,000 / yearThe Senior Director partners closely with Medical Affairs leadership, Clinical Development,, Commercial, Legal, Compliance, Quality, and Learning & Development to build scalable training frameworks, curricula, digital learning solutions, and capability programs that support onboarding, launch readiness, and ongoing professional development. This role leads the development of integrated training programs that equip Medical Affairs teams to communicate complex science clearly, engage credibly with healthcare professionals and key opinion leaders, and execute Dyne's medical strategy in a compliant, consistent, and impactful manner.
Director/Senior Director, Human Resources, Commercial Xenon PharmaceuticalsDirector/Senior Director, Human Resources, CommercialNeedham, MassachusettsThe role advises leaders on organizational structure, workforce planning, leadership capability, talent strategies, and organizational readiness while ensuring the organization has the capabilities, talent, and workforce plans required to support successful commercialization. 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.
Marketing Director - H&N Cancer CareDxMarketing Director - H&N CancerWaltham, MassachusettsRemoteLeadership & Cross-Functional Influence – The Specialty Oncology Marketing Director must be a strong peer leader, self-starter, and collaborator that works effectively across Product, Sales, Clinical, Medical Affairs, and Regulatory to ensure promotional content is clinically accurate, compliant, and strategically aligned. The Marketing Director will partner closely with Sales, Medical Affairs, Clinical Development, Market Access, Digital, Sales Training, Product, and Medical-Legal-Regulatory partners to develop and execute strategies that drive adoption, expand ordering-provider reach, increase utilization, and convert market insights into measurable commercial impact.
Associate Director, Drug Product Technical Services DPTS Wave Life Sciences LtdAssociate Director, Drug Product Technical Services DPTSLexington, MA$163,000–$221,000 / yearOur diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington's disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. By submitting your information in applying for a position at Wave (or lawfully on behalf of a candidate as an approved recruiter), you represent that the information you submit (including your name, phone number, email address, address, and resume/CV/work history) is true and accurate, you have the right to share it, and that no part of the Information violates or infringes the rights of any third parties.
Marketing Director - Anal Cancer CareDxMarketing Director - Anal CancerWaltham, MassachusettsRemote$192,000–$240,000 / yearLeadership & Cross-Functional Influence – The Specialty Oncology Marketing Director must be a strong peer leader, self-starter, and collaborator that works effectively across Product, Sales, Clinical, Medical Affairs, and Regulatory to ensure promotional content is clinically accurate, compliant, and strategically aligned. The Marketing Director will partner closely with Sales, Medical Affairs, Clinical Development, Market Access, Digital, Sales Training, Product, and Medical-Legal-Regulatory partners to develop and execute strategies that drive adoption, expand ordering-provider reach, increase utilization, and convert market insights into measurable commercial impact.
Senior Director, Competitive Intelligence and Product Planning (Oncology) Bicara TherapeuticsSenior Director, Competitive Intelligence and Product Planning (Oncology)Boston, MassachusettsBicara Therapeutics is seeking a Senior Director, Competitive Intelligence and Product Planning who will lead enterprise-level competitive intelligence and product planning to support Bicara's oncology pipeline, with a primary focus on ficerafusp alfa (BCA101), our EGFR/TGF- bifunctional antibody in development for HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), as well as future pipeline expansion opportunities for ficerafusp alfa and potential future assets. Reporting to the VP, Commercial Operations, this senior leadership role will partner closely with Commercial Strategy, Program Strategy, Clinical Development, Medical and Corporate Affairs, Business Development, and Finance to inform pipeline decisions, product strategy, scenario planning, and pre-launch readiness through rigorous competitive assessment, strategic synthesis, and cross-functional alignment.
Medical Director, Global Patient Safety Alexion Pharmaceuticals IncMedical Director, Global Patient SafetyBoston, MAEvaluating aggregate safety data and providing contributions to core regulatory documents i.e. Periodic Safety Update Reports, Drug Safety Update Reports, Risk Management Plans, and other routine and non-routine safety and risk/benefit evaluations for internal or regulatory purposes as required. Representing Alexion GPS at internal strategic and/or advisory/governance committees, other project/product team(s) or subteam(s) as a key cross functional member and subject matter expert, and/or act as an external technical resource at DSMB or Regulatory Authority meetings.