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Job description
Role
Senior legal strategist supporting R&D activities across the Americas, primarily U.S., focused on research, early development, clinical operations, and associated regulatory compliance for innovative medicines.
Responsibilities
provide legal counsel on FDA regulatory requirements, human subject protections, GxP compliance, data sharing, and AI-enabled research
support integration of acquired assets
advise on legal risks related to cross-border data exchanges, collaborations, and new business models
support clinical and biomedical research activities, including privacy, site selection, and data use
partner with security, regulatory, and other teams on AI ethics and legal frameworks
review policies and training for compliance.
Requirements
J.D. or equivalent
admitted in at least one U.S. jurisdiction
8+ years post-bar legal experience in life sciences, preferably biotech/pharma, with expertise in FDA law, clinical development, GxP, and regulatory strategy
strong analytical, judgment, and cross-functional collaboration skills
familiarity with emerging technologies, AI, and global legal considerations.
HighValue
focus on U.S. regulatory landscape, clinical development, GxP, data sharing, AI ethics, biotech/pharmaceutical R&D.
WorkSetup
based in Cambridge, MA or East Hanover, NJ, with a minimum of 3 days/week onsite.
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Worksite address
east hanover, NJ, 07936, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.