Senior Legal Director, R&D and Regulatory Counsel

About the role

The Senior Legal Director, R&D and Regulatory Counsel is a strategic legal leader who enables efficient, high-quality decision-making on regulatory pathways, product development, and lifecycle management. This role provides expert counsel to cross-functional partners across Regulatory Affairs, Public Policy & Government Relations, Therapeutic Area leadership in Cardiometabolic Disease and Neuroscience (and future therapeutic areas), Safety & Risk Management, Quality Assurance, Data Sciences, and Research & Early Development, empowering scientific innovation while managing regulatory and legal risk.

Responsibilities

• Provide 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 interactions;
• Partner with the Public Policy & Government Relations team to influence advocacy strategy and policy engagement, including contributions to trade associations and regulatory reform initiatives;
• Advise 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 protections;
• Serve as a trusted legal advisor to Quality in assessing and investigating allegations, managing inspections, and ensuring compliance with legal and regulatory reporting requirements;
• Monitor 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 opportunities;
• Provide strategic legal support for complex research contracts, including drafting, reviewing, interpreting, and negotiating collaboration, sponsored research, and data and material transfer agreements;
• Collaborate across Legal and cross-functional partners to design integrated legal solutions that enable pipeline delivery, clinical trial execution, and portfolio growth;
• Support the development of scalable policies, processes, templates, tools, and governance that advance Alnylam’s mission to deliver transformative medicines to patients.

Qualifications and Skills

• JD from an ABA-accredited law school and admission in good standing to at least one U.S. jurisdiction;
• Minimum 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 FDA;
• Deep expertise in U.S. regulatory frameworks, with working knowledge of EMA processes preferred;
• Demonstrated experience advising on complex regulatory strategy and novel modalities;
• Demonstrated 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 laws;
• Strategic thinker who translates complex regulations into pragmatic, risk-based business guidance;
• Strong executive presence and proven influence with senior stakeholders in a matrixed organization;
• Exceptional judgment, collaboration, and interpersonal communication skills;
• Maintains an independent, objective perspective while building strong partnerships with colleagues;
• Thrives in ambiguous, high-stakes environments;
• Works independently, manages multiple matters, and delivers high-quality work under tight timelines;
• High integrity, forward-looking perspective, and a solution-oriented approach;
• Advanced contracting and redlining skills, with strong attention to detail;
• Able to manage outside counsel effectively and efficiently while adhering to budget expectations.

Pay

$247,200.00 - $334,400.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k) with a generous company match.