Director, CMC Product Lead
Core
Strategic oversight and execution of CMC strategies for multiple assets from first-in-human to pivotal studies, ensuring alignment with TPP and QTPP.
Role type
Director-level CMC Product Lead
Builds
Actionable CMC plans and technical roadmaps for drug development programs
Domain
Biotechnology/Pharmaceuticals (Drug Development)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> strategic CMC plans and regulatory submissions
Required skills
CMC strategy, Technical Development, Manufacturing, Supply Chain, Quality, Process Development, CMC Regulatory, Cross-functional leadership, Budgeting, Resource allocation
Preferred skills
Biochemistry/Chemistry/Biology/Pharmaceutical Sciences PhD, Executive influence, Financial acumen, Technical storytelling, Negotiation
Technologies
CMC Regulatory submissions, TPP/QTPP frameworks
Responsibilities
Define strategic CMC Development Plans, Translate program strategy into actionable tasks, Serve as primary accountability for CMC plan, Engage in technical discussions and own technical roadmap, Lead CMC team in discussions with leadership, Identify and address cross-functional gaps, Manage resource and financial management of the team
Seniority
Director, strategic leadership & team management
