Director, R&D Legal, Americas

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.

• 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.

• 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.

focus on U.S. regulatory landscape, clinical development, GxP, data sharing, AI ethics, biotech/pharmaceutical R&D.

based in Cambridge, MA or East Hanover, NJ, with a minimum of 3 days/week onsite.