[Remote] Senior Legal Director, Research and Development

Note: The job is a remote job and is open to candidates in USA. Alnylam Pharmaceuticals is a leader in RNAi therapeutics, dedicated to transforming the lives of people with rare and common diseases. They are seeking a Senior Legal Director for Research and Development to provide expert legal counsel on regulatory pathways and product development while managing regulatory and legal risks across various teams.ResponsibilitiesProvide clear, practical legal counsel to R&D and Regulatory colleagues on novel or complex matters involving U.S. and global regulatory pathways, product classification, exclusivity, and lifecycle strategy, and support critical submissions and health authority interactionsPartner with the Public Policy & Government Relations team to influence advocacy strategy and policy engagement, including contributions to trade associations and regulatory reform initiativesAdvise Quality, Safety, Pipeline Delivery, and Legal colleagues on GCP compliance and related risk areas, including fraud prevention, product liability, privacy, pharmacovigilance, inspection readiness, and human subject research protectionsServe as a trusted legal advisor to Quality in assessing and investigating allegations, managing inspections, and ensuring compliance with legal and regulatory reporting requirementsMonitor and interpret evolving legislation, policy, industry standards, and enforcement trends affecting lifecycle management, and provide actionable guidance to stakeholders and leadership on resulting risks and opportunitiesProvide strategic legal support for complex research contracts, including drafting, reviewing, interpreting, and negotiating collaboration, sponsored research, and data and material transfer agreementsCollaborate across Legal and cross-functional partners to design integrated legal solutions that enable pipeline delivery, clinical trial execution, and portfolio growthSupport the development of scalable policies, processes, templates, tools, and governance that advance Alnylam’s mission to deliver transformative medicines to patientsSkillsJD from an ABA-accredited law school and admission in good standing to at least one U.S. jurisdictionMinimum of 12 years of post-JD experience advising on legal matters in the life sciences industry, including significant FDA regulatory law experience gained through law firm practice focused on FDA and regulatory matters or relevant government service, such as at the FDADeep expertise in U.S. regulatory frameworks, with working knowledge of EMA processes preferredDemonstrated experience advising on complex regulatory strategy and novel modalitiesDemonstrated experience advising cross-functional teams on clinical research, drug development, regulatory submissions, GCP, and related compliance frameworks, including regulatory exclusivities, orphan drug designations, as well as privacy, fraud and abuse, and product liability lawsStrategic thinker who translates complex regulations into pragmatic, risk-based business guidanceStrong executive presence and proven influence with senior stakeholders in a matrixed organizationExceptional judgment, collaboration, and interpersonal communication skillsMaintains an independent, objective perspective while building strong partnerships with colleaguesThrives in ambiguous, high‑stakes environmentsWorks independently, manages multiple matters, and delivers high-quality work under tight timelinesHigh integrity, forward-looking perspective, and a solution-oriented approachAdvanced contracting and redlining skills, with strong attention to detailAbility to manage outside counsel effectively and efficiently while adhering to budget expectationsWorking knowledge of EMA processesBenefitsAnnual short-term incentive award (e.g., bonus or sales incentive)Annual long-term incentive award (e.g., equity)Medical, dental, and vision coverageLife and disability insuranceA lifestyle reimbursement programFlexible spending and health savings accounts401(k)with a generous company matchPaid time offWellness daysHolidaysTwo company-wide recharge breaksGenerous family resources and leaveCompany OverviewAlnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization. It was founded in 2002, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is http://www.alnylam.com.