Director, Global Regulatory Strategy, Oncology Moderna IncDirector, Global Regulatory Strategy, OncologyCambridge, 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. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate.
Associate Director, Global Regulatory CMC Moderna IncAssociate Director, Global Regulatory CMCNorwood, MA$142,500–$256,500 / 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. Provides interpretation of regulatory guidance documents, regulations and directives - advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.
Sr. Director, Head, Quantitative Systems Pharmacology Moderna IncSr. Director, Head, Quantitative Systems PharmacologyCambridge, MA$196,700–$353,400 / yearIn addition to leading QSP strategy and capabilities, this role is expected to serve directly as the CQP representative within key program teams, driving model-informed drug development strategy and enabling portfolio decisions in close partnership with cross-functional leaders. This leader will define and execute the vision for how mechanistic modeling, systems biology, and model-informed drug development (MIDD) approaches are applied across discovery, preclinical, and clinical stages to accelerate early development decisions, strengthen translational understanding, and optimize dose, schedule and patient selection strategies.
Associate Director, Clinical Operations - Oncology Moderna IncAssociate Director, Clinical Operations - OncologyCambridge, MA$142,500–$256,500 / 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. This position will be responsible for initiating and leading clinical trials across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives.
Associate Director, Global Regulatory, CMC Moderna IncAssociate Director, Global Regulatory, CMCNorwood, MA$142,500–$256,500 / 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. The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle.
Associate Director, Process Development (Fermentation) Moderna IncAssociate Director, Process Development (Fermentation)Norwood, MA$142,500–$256,500 / 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. Moderna is seeking an Associate Director, Process Development to lead upstream/fermentation process development for E. coli-based production of recombinant enzymes, plasmids, and related biological starting materials critical to Moderna's technology platforms and pipeline programs.
Associate Director, Clinical Supplies Project Manager Moderna IncAssociate Director, Clinical Supplies Project ManagerCambridge, MA$142,500–$256,500 / 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. The scope includes the operational planning and strategy required to execute end-to-end supply management, including demand planning, label development, packaging/labeling, distribution, IRT UAT/supply management, temperature excursions, and site activations.
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.
Senior Director, Global EHS Waters CorporationSenior Director, Global EHSMilford, MAThis position partners closely with Facilities, Real Estate, Quality, Manufacturing, R&D, and Corporate Leadership to deliver enterprise wide EHS initiatives, support regulatory compliance, and enable operational excellence across a complex, global real estate portfolio. We collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance.
NewSenior Director, Field Reimbursement Alexion Pharmaceuticals IncSenior Director, Field ReimbursementBoston, MAProven experience creating and managing compliant field-based reimbursement and access teams, including key account targets, size, structure, strategy, programs/initiatives, compliance requirements (PHI), KPIs, analytics, integration with patient support services. Superb knowledge of government and commercial payers for specialty products (rare disease) across buy & bill and specialty pharmacy pathways, prior authorization and appeal requirements, coding, appropriate claim submission, and integration with patient assistance programs.
NewAssociate Dir/Director Commercial Forecasting & Analytics Zealand PharmaAssociate Dir/Director Commercial Forecasting & AnalyticsCambridge, MassachusettsAs Associate Director of Forecasting, you will work closely with colleagues in market research and competitive intelligence, with cross-functional partnerships in Commercial, Clinical Development, R&D, and corporate strategy. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.
Director, Quality Assurance (Operations) Zevra TherapeuticsDirector, Quality Assurance (Operations)Boston, Massachusetts10+ years of progressive experience in pharmaceutical/biotech industry with expertise in establishing effective and efficient systems and processes supporting pre-clinical, clinical and commercial programs, 7+ years of Quality leadership experience with a successful track record in vendor oversight and managing relationship with external stakeholders as well as internal QA systems in a virtual environment, 7+ years’ experience in the establishing and administering of GCP-, GLP- and GDP compliant systems, Bachelors or Advanced degree in a scientific or related discipline, Understanding of worldwide requirements of GxP compliance and quality systems for clinical and commercial products, Leadership role in the management of regulatory/health authorities inspections, Experience with new product launch and implementation of serialization systems and commercial product complaint processes is a plus, Strong team player that has a customer service approach and is solution oriented, Ability to travel both domestically and internationally as needed, likely to be ~10 15%, The candidate will need to embrace Zevra’s mission and core values, Ability to effectively communicate with inspiration, lead and influence individuals from multiple functional departments at all levels of the organization, Strong organizational and time management skills to balance working on multiple projects and initiatives in parallel, A proven self-starter capable of high performance with limited direction and oversight, Excellent people leader with strong mentorship skills. This includes, but is not limited to, audit planning and execution, reporting and coordination with external contractors, Supports periodic GxP training and ensure that training requirements are consistently met, as required, In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required, Responsible for Quality Review Boards, providing technical expertise for product quality decisions, Responsible for manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required, Support continuous improvement initiatives to optimize Zevra’s quality and compliance position, Cross-train and serve as back-up for Quality Systems, as assigned.
NewSr. Manager / Associate Director, Late-Phase Drug Substance Pd/Msat Third Rock VenturesSr. Manager / Associate Director, Late-Phase Drug Substance Pd/MsatCambridge, MA$165,000–$200,000 / yearWorking closely with CDMO partners and CMC team to define upstream and downstreaM late phase activities such as process characterization studies with qualified SDM to establish proven acceptable ranges (PARs) and design space, applying QbD principles and statistical modeling (DoE, multivariate analysis) to drive control strategies. Manage day-to-day technical relationships with the CDMO partner; oversee execution of development and manufacturing workstreams, ensure alignment on timelines and deliverables, ensure cross-functional alignment on process interfaces, in-process sampling, and release testing strategy and lead technical governance meetings.
Director, Analytical Chemistry Moderna IncDirector, Analytical ChemistryCambridge, MA$167,000–$300,700 / yearThe Role: Moderna is seeking a Director, Analytical Chemistry to provide scientific, strategic, and organizational leadership for discovery-stage analytical chemistry activities supporting mRNA-lipid nanoparticle (LNP) research across a diverse portfolio of nucleic acid medicines. This leader will define and advance analytical strategies that enable rapid design-make-test-learn cycles across novel ionizable lipids, polymers, excipients, payloads, formulations, and delivery systems used in mRNA-LNP therapeutics and vaccines.
Associate Director - Value, Access, Insights, and Solutions Takeda Pharmaceutical Co LtdAssociate Director - Value, Access, Insights, and SolutionsLexington, MA$169,400–$266,200 / yearDevelops and maintains a broad network of mutually supportive relationships with internal Takeda colleagues (Medical Product Teams, Medical Communications, VEG, Marketing, Managed Markets, Market Access Channel Strategy, Government External Affairs, Account Management and other affiliates) to ensure US Medical scientific and outcomes research and external affairs strategies are integrated across groups. How you will contribute: The Associate Director of Value Access Insights & Solutions is an integral member of the Marketing Content Enablement & Customer Engagement group and is responsible for: Serving as a partner to Product Medical Units, Medical Communications, Medical leads, Field Medical Leaders, Brand Teams, Market Access and Channel Strategy, Public Affairs and other Global and US internal stakeholders to ensure strategic alignment on cross-functional imperatives and initiatives.
Associate Director, P&O Operations Zealand PharmaAssociate Director, P&O OperationsCambridge, MassachusettsThe team supports leaders and colleagues across the employee lifecycle and plays a key role in enabling smooth day-to-day operations through clear processes, high-quality data, and reliable documentation. The role acts as a key operational link between U.S. employees, People leaders, external vendors (Workday, TriNet), and People Operations in Denmark.
Director, Business Development - Search & Evaluation TrialSparkDirector, Business Development - Search & EvaluationBoston, MA$228,000–$310,000 / yearRecognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients.
NewAssociate Director, Regulatory Data Management & Intelligence Moderna IncAssociate Director, Regulatory Data Management & IntelligenceCambridge, MA$142,500–$256,500 / yearThe Associate Director will establish enterprise data governance, define business capabilities, and partner closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, Digital, and external technology partners to continuously improve regulatory business processes, regulatory data quality, and enterprise technology capabilities. We 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.
Pioneering Medicines: Senior Director, Head of Toxicology Flagship Pioneering IncPioneering Medicines: Senior Director, Head of ToxicologyCambridge, MA$228,000–$310,000 / yearFlagship has been recognized twice on FORTUNE's "Change the World" list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies, and has been named four times to Fast Company's annual list of the World's Most Innovative Companies. Harnessing the drug development expertise of its team together with the power of Flagship''s multiple scientific platforms, Pioneering Medicines explores and identifies new product concepts which are then advanced jointly with Flagship's bioplatform companies.
Associate Director Finance Flagship Pioneering IncAssociate Director FinanceCambridge, MA$148,000–$203,500 / yearProvide accounting and controllership support for PM, Flagship Labs, or related portfolio company needs as required, including GAAP compliance, audit support, financial statement review, close process support, ASC 842 lease accounting, capital project tracking, and accounting policy or process implementation. While this role is primarily focused on the Pioneering Medicines business unit, the successful candidate should also bring strong accounting and controllership capabilities and be able to provide cross-functional support to Flagship Labs or related portfolio company finance teams as business needs require.