Associate Director, CMC Quality PM - Global Programs

Summit Therapeutics Inc.; Princeton (NJ); On-site; USD 174,000 - 204,000; Full time

Job summary

Summit Therapeutics Inc. is seeking an Associate Director, CMC / Quality Project Management in Princeton, NJ.

This senior, individual-contributor role leads cross-functional CMC/Quality programs across development stages, coordinating with Regulatory, Manufacturing, and external partners to ensure submission readiness and clinical supply integrity. The role emphasizes strategy, risk-based decision making, and governance, with cross-functional collaboration and potential travel for global

Qualifications

• 8+ years in pharma/biotech with CMC development and regulatory filing experience.
• Experience with late-stage biologics and regulatory submissions (BLA, MAA).
• Proven success leading global, matrixed teams in regulated environments.
• PMP-certified with strong project governance skills.

Responsibilities

• Provide CMC/Quality program leadership across cross-functional teams.
• Develop CMC submission plans, timelines and risk strategies for BLA filings.
• Prepare senior-management decision memos and governance reports.
• Implement tools, workflows to enhance efficiency and quality of CMC operations.
• Lead external collaboration with CDMOs/CMOs and monitor KPIs.
• Travel as needed; adapt to global meetings.

Skills

PMP certification

Leadership

Public speaking

Cross-functional collaboration

Risk management

MS Office

Power BI

Smartsheet

MS Project

Office Timeline

Education

Bachelor’s degree in life sciences/chemistry/engineering

Advanced degree desirable (MS/PhD/MBA)

Tools

Smartsheet

MS Project

Power BI

Office Timeline

Job description

Summit Therapeutics Inc. is seeking an Associate Director, CMC / Quality Project Management in Princeton, NJ.

This senior, individual-contributor role leads cross-functional CMC/Quality programs across development stages, coordinating with Regulatory, Manufacturing, and external partners to ensure submission readiness and clinical supply integrity. The role emphasizes strategy, risk-based decision making, and governance, with cross-functional collaboration and potential travel for global