Director, R&D Counsel

Role Summary

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.

Responsibilities

• 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.

Qualifications

• 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 sciences space, whether in a law firm or in-house in the biopharmaceutical industry or both;
• Deep knowledge of laws and regulations governing clinical research, regulatory affairs, data protection, and product development in the U.S. and ex-U.S. markets;
• Prior experience advising cross-functional teams on drug development, regulatory submissions, GCP, and related compliance frameworks, including regulatory exclusivities, orphan drug designations, and privacy, fraud and abuse, and product liability laws;
• Exceptional oral and written communication skills, including drafting and presentation capabilities
• Excellent interpersonal and conflict resolution skills and ability to work in a highly collaborative, team-oriented environment;
• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organizations;
• History of self-motivation, working independently on projects, meeting aggressive deadlines, and juggling multiple matters;
• High integrity and demonstrated ability to treat confidential information with great discretion;
• Able to exercise good judgment, be forward looking, and stay solution-oriented across situations
• Experience working for, or having interactions with, government health authorities highly desirable
• Advanced contracting and redlining skills with strong attention to detail;
• Excellent analytical, problem-solving and organizational skills to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards;
• Ability to effectively and efficiently manage outside counsel and adhere to a budget.