Director, CMC Product Development
Core
Lead the CMC strategy and development plan for complex assets from late discovery through commercial manufacturing, serving as the single CMC spokesperson and integrator for the Asset Strategy Team.
Role type
Director, CMC Product Development (Strategic Leadership & Cross-Functional Management)
Builds
Integrated CMC strategies and development plans for complex pharmaceutical assets
Domain
Pharmaceutical development (small molecules, biologics, ADCs, cell and gene therapies, devices)
Required skills
CMC strategy, cross-functional leadership, stakeholder alignment, risk management, strategic planning, scientific judgment, matrix influence, program portfolio management
Preferred skills
Biologics development, complex modalities (ADCs, CGT), strategic collaborations, due diligence, external innovation integration
Technologies
None explicitly listed
Responsibilities
Serve as CMC leader and spokesperson on the Asset Strategy Team; Lead and inspire matrixed cross-functional CMC and Product Presentation teams; Develop and drive integrated CMC strategy and development plans; Communicate complex CMC topics to diverse audiences and governance bodies; Build relationships across CMC, Clinical, Regulatory, Quality, and Commercial functions; Shape team culture promoting scientific excellence and collaboration; Lead a portfolio of programs across multiple modalities
Seniority
Director, strategic leadership with 0-3 direct reports