Senior Director, CMC Lead Product Development

Role: Senior Director, CMC Lead responsible for strategic product development and cross-functional coordination across clinical stages for small molecule drugs in cardiovascular disease. Responsibilities: lead CMC (drug substance, drug product, analytical) development, represent CMC in governance forums, integrate input from multiple disciplines, manage project teams, and ensure alignment with regulatory standards (ICH, FDA, EMA). Acts as strategic liaison between research, manufacturing, quality, regulatory, and portfolio teams, supporting global supply chain and technical operations. Mentors team members and leads high-profile collaborations. Requirements: Ph.D. in Chemistry, Pharmaceutical Sciences, Engineering, or related field with 10+ years (Ph.D.) or 15+ years (M.S.) of experience in CMC, drug development, or analytical sciences, with expertise in small molecule APIs, formulation, analytical development, and regulatory compliance. Skills: strong leadership, communication, negotiation, project management, and deep technical knowledge of CMC processes, including IND and NDA/MAA pipelines. Preferred: experience with oral solid dosage forms, multiple asset modalities, and global program management. HighValue: cardiovascular therapeutic focus, small molecule development, development from preclinical to commercial stages, global regulatory environment, cross-functional leadership, and strategic risk management. Location: South San Francisco, CA.