Associate Director/Director, Development Program Management, CMC
Core
Strategic and operational project management leadership for CMC teams, driving integrated planning and execution for early-stage drug development programs.
Role type
Associate Director/Director, Development Program Management, CMC
Builds
Early-stage small molecule drug substance and drug product development programs
Domain
Biopharmaceuticals / Neuroscience / CMC
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
CMC project management, cross-functional stakeholder alignment, risk management, budget planning, regulatory submission support (IND/IMPD), Smartsheet proficiency, Microsoft Project
Preferred skills
API development, solid oral dosage forms, NDA/MAA submission experience, PMP certification, advanced degree
Technologies
Smartsheet, Microsoft Project, Microsoft Office
Responsibilities
Plan and manage budget proposals and approved budgets; Lead project management for CMC activities including tech transfer and scale-up; Develop and maintain project management tools and reporting; Drive team execution and governance through effective meeting management; Monitor project progress and develop mitigation plans; Improve CMC project management effectiveness through scalable tools and automation
Seniority
Director level, hands-on IC with strategic oversight
