Manager – Clinical Supply Chain

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $131.8k - $176.8k / year

⏰ Full Time

🟠 Senior

🔗 Supply Chain

👻 Ghost score 0%

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Manage drug supply activities for one or more clinical studies, 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 • Align clinical demand requirements, supply plans, and timelines with Clinical Operations and study teams • Create supply and inventory plans and develop production schedules for clinical trial materials • Monitor production schedule adherence and make course corrections • Manage GMP inventory, inventory reports, upcoming expiry, and drug accountability • Manage label and pack CMOs and distribution vendors and oversee their daily activities • 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 stakeholder and CMO review and approval of labels • Support IRT user acceptance testing, develop IRT supply strategy, and oversee ongoing system supply activities • Coordinate and track bulk shipments to CMOs, depots, and vendors and maintain import licenses • Develop supply strategies, identify risks, and develop mitigation plans • Lead cross-functional drug supply projects and process improvements • Create and revise Standard Operating Procedures • Ensure supportive staff meet deliverables for successful study management

🎯 Requirements

• Bachelor or Master Degree in Business Administration, Operations Management, or similar education required • 7+ years progressive experience in Clinical 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 • Knowledge of applicable rules, regulations, product specifications, and clinical study protocols • Ability to create supply and inventory plans and production schedules for clinical trial materials • Ability to manage GMP inventory and drug accountability • Ability to manage label and pack CMOs and distribution vendors • Ability to investigate exceptions, determine root causes, implement CAPAs, and drive closure • Ability to coordinate label review and approval • Ability to support IRT user acceptance testing and develop IRT supply strategy • Ability to coordinate and track bulk shipments and maintain import licenses • Ability to develop risk mitigation plans • Ability to lead cross-functional projects and process improvements • Ability to create and revise Standard Operating Procedures

🏖️ 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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