Senior Director, CMC Program Management

1. End-to-End CMC Leadership & Cross-Functional Integration

• Create and execute against integrated cross-functional project plans, leading the integrated CMC strategy.
• Translate program strategy into cohesive development, manufacturing, and supply plans with clear milestones and deliverables.
• Drive cross-functional alignment in close partnership with Clinical Development, Regulatory Affairs, Quality, Supply Chain, Commercial, and Finance teams.
• Guide and lead project performance, risk and financial management, and issues resolution for functional groups.
• Provide direction on requirements to meet internal and external stakeholders’ expectations.
• Ensure CMC activities are executed in lockstep with clinical timelines, regulatory milestones, and commercial launch plans.
• Serve as the CMC representative on program governance teams, influencing key decisions and trade-offs across functions.

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