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. 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.