Director or Senior Director, CMC Program Management

Role: Senior Director, CMC Program Management leading mid to late-stage small molecule degraders. Responsibilities: oversee end-to-end CMC planning, including timelines, risk management, and execution for drug substance, drug product, analytical, and regulatory activities; coordinate with CDMOs/CROs and support global regulatory filings; develop CMC best practices and foster cross-functional collaboration. Requirements: PhD, MS, or equivalent in pharmaceutics, chemistry, or related field; 10+ years (PhD) or 15+ years (MS) CMC experience; proven management of oral small molecule programs through Phase 3, NDA/MAA submission, and commercialization; broad technical knowledge in drug development, GMP manufacturing, and regulatory compliance; strong communication, organizational, and project management skills using tools like MS Project or similar. HighValue: focus on oral small molecule degraders, Phase 3, NDA/MAA submission, process validation, commercial supply, GMP, FDA/EMA/ICH regulatory environment. WorkSetup: not specified; likely hybrid or onsite given the nature of CMC activities.