Manager, CMC Project Management

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

• Lead cross-functional CMC project management for clinical-stage development programs, developing and maintaining integrated project plans, timelines, critical path activities, milestones, risks, and decision logs.
• Drive project execution by facilitating cross-functional meetings, tracking actions and decisions, proactively identifying risks and dependencies, and escalating issues to ensure program objectives are achieved.
• Coordinate activities across Drug Substance, Drug Product, Analytical Development, Quality Control, Quality Assurance, Supply Chain, Regulatory CMC, and other Technical Operations functions to ensure alignment of priorities and deliverables
• Partner with CDMOs, CROs, testing laboratories, and other external vendors to monitor deliverables, manufacturing activities, timelines, and issue resolution.
• Coordinate planning and execution of CMC regulatory submissions, including INDs, IMPDs, amendments, and health authority responses, ensuring cross-functional deliverables are completed on schedule.
• Support program budgeting, forecasting, resource planning, purchase order tracking, and financial reporting to enable effective execution of CMC development activities.
• Identify and implement process improvements to strengthen CMC project execution, governance, resource planning, and organizational effectiveness.