Manager, Senior Manager – Clinical Supply Chain
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Job Description
Clinical supply chain manager overseeing planning, labeling, inventory, and distribution of BeOne’s clinical-trial drug supplies. Ensuring continuous patient supply while reducing waste and operational risk.
Responsibilities:
- Manage drug supply activities for one or more clinical programs, including planning, label development, label and pack, and distribution
- Develop and oversee supply plans to ensure continuous patient supply while reducing risk and minimizing waste
- Represent Clinical Supply Chain on Clinical Study Teams and support internal stakeholders including Clinical Operations, Regulatory, Quality, and CMC
- Work with Clinical Operations to understand clinical demand requirements and align supply plans and timelines
- Create supply and inventory plans and develop production schedules for clinical trial materials
- Monitor production schedule adherence and make course corrections when needed
- Manage GMP inventory, develop inventory reports, monitor upcoming expiry, and ensure drug accountability
- Oversee daily activities of finished-goods label and pack CMOs and distribution vendors
- Investigate exceptions, determine root causes, implement CAPAs, and drive closure
- Ensure label text and proofs comply with applicable rules, regulations, product specifications, and clinical study protocols
- Coordinate label review and approval with Regulatory, Clinical Operations, CROs, and CMOs
- Support IRT user acceptance testing and develop IRT supply strategy, including DNX parameters
- Coordinate and track bulk shipments to CMOs, depots, and vendors; maintain and track import licenses
- Develop supply strategies, identify risks, and create risk mitigation plans
- Support functional projects and drug-supply process improvements, including creating or revising SOPs
- Ensure supporting staff meet deliverables for successful study management
Requirements:
- Bachelor’s or master’s degree in business administration, Operations Management, or a related field required
- Minimum of 5 years of progressive experience in supply chain, preferably within the biotech, pharmaceutical, or CRO industry
- Working knowledge of clinical supply best practices
- Experience with IRT systems
- Experience working within a cGMP environment
- Ability to develop supply and inventory plans and production schedules for clinical trial materials
- Knowledge of applicable rules, regulations, product specifications, and clinical study protocols for labeling
- Ability to investigate exceptions, determine root causes, implement CAPAs, and drive closure
- Ability to coordinate and track shipments and maintain import licenses
Benefits:
- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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