Director, R&D Legal, Americas

RoleSenior 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. Responsibilitiesprovide 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. RequirementsJ.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. HighValuefocus on U.S. regulatory landscape, clinical development, GxP, data sharing, AI ethics, biotech/pharmaceutical R&D. WorkSetupbased in Cambridge, MA or East Hanover, NJ, with a minimum of 3 days/week onsite.