Associate Director / Director, CMC Product Development

📋 Description

• Manages multiple clinical development programs of high complexity using matrix management.
• Leads CMC teams and PPDS T teams with cross-functional partners for external collaborations.
• Co-chairs PPDST for Asset Strategy Teams and crafts CMC strategy aligned to asset strategy.
• Acts as CMC spokesperson; ensures information flow among AST, line functions, and stakeholders.
• Supports global filings and regulatory communications; informs management of plans and risks.
• Scope from late-discovery to tech transfer to commercial manufacturing sites.