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.

Summary of Key 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 negotiate 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.

U.S. Pay Range

$221,000.00 - $299,000.00

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. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

About Alnylam

We are the leader in RNAi therapeutics - a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.