Vice President, CMC Strategy

Required

• Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or related scientific discipline.
• At least 15 years of progressive experience in pharmaceutical or biotechnology CMC, including significant leadership experience overseeing complex development programs and global CMC activities across the full product lifecycle.
• Demonstrated experience leading CMC organizations, developing organizational capabilities, and managing high-performing teams.
• Extensive experience developing and executing global CMC strategies across preclinical, clinical, and commercial-stage programs including CMC asset leadership and program team representation.
• Proven track record leading successful global regulatory submissions, product approvals, and commercial readiness activities.
• Strong understanding of global CMC regulatory requirements, including FDA, EMA, PMDA, ICH, and applicable cGMP standards.
• Demonstrated expertise in CMC lifecycle management, including post-approval changes, global market expansion, comparability strategy, and regulatory commitments.
• Strong understanding of pharmaceutical development and manufacturing, with experience in both large and small molecules, preferred.
• Experience leading complex cross-functional programs and partnering effectively with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, and Supply Chain.
• Strong business acumen with the ability to translate scientific, regulatory, and operational considerations into strategic business decisions.
• Demonstrated ability to establish priorities, manage competing demands, anticipate risks, and drive execution across multiple programs.
• Exceptional leadership, communication, influencing, and collaboration skills, with demonstrated effectiveness working across functions and with senior executives.