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Director, R&D Counsel

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Job Description - Director, R&D Counsel

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; Advise on strategic contracting for research and technology collaborations, including Drafting, reviewing, interpreting and negotiate sponsored research agreements, material transfer agreements, and collaboration agreements; 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; 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.
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