Director, CMC Product Development - Late Stage, Operations
Core
Lead CMC development strategy for late-stage assets (small molecules, biologics, ADCs) and device presentations, ensuring alignment with clinical and regulatory strategies.
Role type
Director, CMC Product Development (Late Stage)
Builds
CMC development plans and strategies for late-stage drug and device programs
Domain
Biopharmaceuticals / CMC / Regulatory Affairs
Required skills
CMC strategy, regulatory compliance, project management, resource negotiation, contract review, cross-functional leadership, scientific writing, risk communication
Preferred skills
NDA/BLA/PMA/510K submission experience, device regulatory knowledge, entrepreneurial thinking
Technologies
None stated
Responsibilities
Represent CMC areas at asset-level governance, evaluate and integrate drug substance/product/device inputs, manage multiple projects and resource prioritization, review external partner contracts, represent company in high-profile partnerships, ensure regulatory and safety compliance, communicate plans and risks to management
Seniority
Director, strategic leadership & cross-functional management