Manager, Clinical Supply Operations

Role: Manager, Clinical Supply Operations at a clinical-stage oncology biotech, overseeing cGMP supply chain for biologics and small molecules. Responsibilities: manage clinical packaging/distribution vendors as Supplier Relationship Manager, lead Virtual Management Teams to ensure milestones (labeling, production, logistics), monitor supply, collaborate on study design and demand planning, review batch records and change requests, coordinate shipments, support contractual negotiations, monitor KPIs and vendor performance, and assist in sourcing and risk mitigation. Requirements: minimum 5 years overseeing outsourced cGMP clinical packaging/labeling in biotech/pharma, strong organizational and communication skills, familiarity with cGMP operations, IRT/RTSM systems, and enterprise planning tools; experience with highly potent products preferred. Travel: up to 25%, including domestic and international. High-Value: biologics and small molecule clinical programs, cGMP supply management, vendor oversight, and risk mitigation for early-phase clinical trials.