Associate Director, CMC / Quality Project Management

The role

This individual contributor will provide CMC and Quality program leadership in cross-functional team settings. The role focuses on driving success in CMC, Supply, Quality, and Business activities across the biologics development lifecycle.

What you will do

• Represent the Program Management department in cross-functional teams
• Develop and maintain CMC submission plans, timelines, and risk mitigation strategies
• Prepare presentations, decision memos, and status reports for senior management
• Implement and refine program tools, workflows, and processes
• Ensure alignment in CMC strategy for early stage and late-stage biologics
• Identify, track and mitigate risks and opportunities
• Develop and maintain CMC plans including scenario planning and dashboards
• Provide clinical supply inputs to development scenarios and forecasts
• Support clinical trial start-up and execution by tracking supply dependencies
• Serve as the primary CMC PM interface for CDMOs/CMOs

Required qualifications

• Bachelor’s degree in life sciences, chemistry, engineering, or related field
• 8+ years in pharmaceutical/biotech industry
• Substantial experience in CMC development, late-stage biologics, and regulatory filing preparation (BLA, MAA)
• Proven success leading global, matrixed, cross-functional teams in a regulated environment
• Strong skills in integrated project planning, risk management, resource allocation, and budget oversight
• Proficient user of MS Office suite
• Excellent communicator in public-speaking, meeting facilitation and email communication
• Ability to excel in a fast-paced, demanding and diverse environment

Nice to have

• Advanced degree (MS, PharmD, PhD, MBA)
• Professional proficiency in Mandarin
• PMP certified
• Experience with tools like Smartsheet, MS Project, Power BI, Office Timeline etc.
• Late-stage to commercialization phase experience and biologics
• Prior oncology experience in late-stage development
• Understanding of GMP, manufacturing and global regulatory supply chains

Benefits

• Bonus
• Stock
• Benefits

About the company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs.