Director, R&D Counsel

Legal Director, R&D and Regulatory

The Legal Director, R&D and Regulatory will serve as a trusted advisor providing expert legal counsel and strategic guidance across Alnylam's Research & Early Development (ReDev), Regulatory, Global Patient Safety & Risk Management, and Data Science teams and support compliance with applicable laws and regulations, while enabling innovation in a fast-paced, science-driven environment.

Reporting to the Executive Director, Head of R&D Legal this individual will operate in a highly collaborative matrix setting , partnering effectively across Alnylam's Expertise Areas - and Legal and Compliance sub-functions (IP Legal, Corporate Transactions & Alliances Legal, Commercial Legal, Ethics & Compliance (E&C), Privacy) - to anticipate risks, identify opportunities and shape legal frameworks that support Alnylam's R&D vision and growth.

Aligned with the company's R&D strategy, this role will particularly:

• Partner with Therapeutic Area (TA) Heads in Cardiometabolic Disease, Neuroscience (and future TAs) to maintain strong program governance and provide support across the product development spectrum (e.g., preclinical, clinical development), including guidance on FDA / ex-US regulations and interactions with agencies, lifecycle management, GCP compliance, data privacy, collaborations with investigators, and data dissemination;
• Support initiatives to accelerate growth in existing franchises through internal and external innovation, including by collaborating with IP Legal and Corporate Transactions & Alliances Legal on academic partnerships, technology evaluations, and other research efforts;
• Help build research capabilities in complementary modalities that extend the reach of genetic medicines as Alnylam scales;
• Collaborate with the Quantitative Sciences group and the IT Expertise Area on advanced analytics, real‑world data, and AI‑driven initiatives;
• Provide partnership to Legal colleagues supporting clinical pipeline delivery and trial execution.

• Provide clear, practical legal advice to R&D and Regulatory colleagues in areas including fraud prevention, product liability, privacy, pharmacovigilance, inspection readiness, human subject research protections, and regulatory enforcement;
• Partner cross‑functionally to develop governance frameworks, training, and guidance supporting compliant and innovative R&D practices;
• Interpret evolving global laws/regulations/guidance impacting clinical research and development, including working with external counsel as appropriate, and advising on risk mitigation;
• Advise on strategic contracting for research and technology collaborations, including drafting, reviewing, interpreting and negotiating sponsored research agreements, material transfer agreements, and collaboration agreements;
• Partner with IP Legal and Corporate Transactions & Alliances Legal to safeguard intellectual property, structure collaborations, and support due diligence for business development initiatives;
• Give legal support to Quality Assurance in assessing and investigating allegations, managing inspections, and ensuring compliance with legal/regulatory reporting requirements;
• Partner with other Legal and E&C/Privacy colleagues and the Quantitative Sciences and Data Science teams to ensure appropriate data governance, privacy, and ethical use of real‑world data and AI applications;
• Collaborate across the R&D Legal team and other cross‑functional partners to design integrated legal solutions that enable pipeline delivery, clinical trial execution, and portfolio growth;
• Provide legal expertise to the development of scalable policies, processes, templates, tools, and governance principles that support Alnylam's expansion and its mission to deliver transformative medicines to patients;
• Monitor and anticipate changes in R&D‑related laws, regulations, and industry standards, proactively updating internal stakeholders and helping shape internal policies and safeguards.

• JD from an ABA-accredited law school; admitted in good standing to at least one U.S. jurisdiction
• Minimum of 8 years post‑JD experience advising on legal matters in a life…