Alnylam Pharmaceuticals · 1 day ago
Director, R&D Counsel
Cambridge, MA
Full-time
Onsite
Director/Executive
$221K/yr - $299K/yr
8+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, and they are seeking a Legal Director, R&D and Regulatory to provide expert legal counsel and strategic guidance across various teams. The role involves collaborating with cross-functional teams to ensure compliance with laws and regulations while supporting innovation in a fast-paced environment.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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
Qualification
Required
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
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
Preferred
Experience working for, or having interactions with, government health authorities highly desirable
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
2025-12-22
2025-12-20
Company data provided by crunchbase