Manager, Clinical Supply Chain

US-Remote
Full time
R01503
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to
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accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.
The Clinical Supplies Manager oversees clinical supply planning, inventory, packaging, labeling, distribution, change implementation, and vendor coordination for assigned clinical studies and programs. The role partners closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, SMPA external partners, CMOs, and other stakeholders to support study teams and ensure timely availability of Investigational Product (IP) for clinical trials. This position helps align supply execution with study timelines, manages supply risks and issues, and ensures activities are conducted in accordance with applicable regulations, quality standards, and company procedures.
KEY RESPONSIBILITIES:
End-to-End Clinical Supply Strategy, Planning, and Execution
• Lead end-to-end Clinical Supply Chain activities for assigned early- and late-phase clinical programs, including supply strategy, forecasting, planning, packaging and labeling, distribution, change control management, returns, reconciliation, destruction, and study closeout.
• Develop and maintain clinical supply forecasts, supply plans, CTM milestones, and integrated timelines in collaboration with Clinical Operations, CMC, PDM, and other stakeholders to support study start-up, enrollment, treatment continuity, and program execution.
• Translate protocol requirements, enrollment assumptions, study design, dosing schedules, IRT/RTSM parameters, country activation plans, manufacturing lead times, expiry considerations, impacts into practical, compliant, and cost-effective supply strategies.
• Identify, manage, and escalate supply risks and issues, including manufacturing or packaging delays, enrollment changes, expiry limitations, temperature excursions, import/export delays, distribution constraints, inventory shortages, and site supply risks.
Packaging, Labeling, Inventory, and Distribution Management
• Manage protocol-level CTM packaging, labeling, storage, distribution, disbursement, inventory movement, returns, reconciliation, and destruction in alignment with study design, treatment duration, regional requirements, patient needs, and clinical trial execution plans.
• Design, review, and approve clinical label text, label specifications, packaging configurations, labeling and packaging requirements, and clinical supplies protocol content in collaboration with Regulatory Affairs, QA, Clinical Operations, CMC, and other stakeholders.
• Ensure IP management, labeling, packaging, storage, distribution, documentation, and batch record activities comply with clinical protocols, cGMP, GCP, GDP, ICH, FDA, U.S. and international regulations, local requirements, company SOPs, and applicable guidance documents.
• Manage IP inventory levels across manufacturers, packaging facilities, depots, and clinical sites; monitor screening, enrollment, randomization, dosing, discontinuation, resupply, expiry, and accountability data to maintain supply readiness.
• Manage clinical supply logistics and resolve shipment, temperature excursion, damage, import/export, customs, documentation, inventory, labeling, site inventory, and depot issues in coordination with internal Trade Compliance & Logistics and external partners.
Systems, Data Integrity, Vendor, Financial, and Cross-Functional Management
• Apply understanding of clinical study design and execution, including randomized, blinded, and open-label stud

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