BeOne Medicines

Compensation

Full Description

Job Description: • 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