Senior Director, CMC Program Lead

Senior Director, CMC Program Lead

The Senior Director, CMC Program Lead will serve as a strategic and operational leader, overseeing the execution of Scholar Rock's CMC development and manufacturing programs. This individual will drive cross-functional coordination across Process Development, Analytical Sciences, Manufacturing, Quality, and Regulatory CMC to ensure delivery of key program milestones across the lifecyclefrom early development through launch and lifecycle management. The role requires an experienced, proactive leader who thrives in a fast-paced, science-driven biotech environment.

Position Responsibilities :

• Serve as the CMC Program Lead for key pipeline assets and commercial products, ensuring integrated planning, execution, and governance across internal and external functions.
• Lead cross-functional CMC program teams, aligning timelines, deliverables, and risk mitigation strategies across drug substance, drug product, device, packaging, and supply chain.
• Drive development and execution of CMC plans in support of IND, BLA / MAA submissions, and global launches, ensuring alignment with regulatory requirements and commercial readiness.
• Partner closely with Process Development and Manufacturing teams to oversee technical transfer, process validation, and comparability planning.
• Maintain accountability for CMC timelines, budget, resource planning, and key deliverables.
• Serve as the primary interface between CMC and program leadership, translating technical strategy into executable operational plans.
• Facilitate technical governance meetings, decision-making forums, and stage-gate readiness reviews.
• Support regulatory strategy development and health authority interactions as the CMC lead contributor.

Candidate Requirements :

Preferred Experience :

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.