Manager, Clinical Supply Chain

Socket.dev; Marlborough (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Sumitomo Pharma America, Inc. is seeking a Clinical Supplies Manager to oversee clinical supply planning, inventory, packaging, labeling, distribution, and vendor coordination for assigned studies and programs.

The role works closely with CMC, Regulatory Affairs, QA, Clinical Operations, SMPA external partners, CMOs, and other stakeholders to ensure timely availability of Investigational Product for trials and to align supply execution with study timelines, manage risks, and ensure compliance

Responsibilities

• Lead end-to-end Clinical Supply Chain activities for assigned programs, including supply strategy, forecasting, planning, packaging and labeling, distribution, change control management, returns, reconciliation, destruction, and study closeout.
• Develop clinical supply forecasts 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 elevate 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.
• Manage protocol-level CTM packaging, labeling, storage, distribution, disbursement, inventory movement, returns,

Job description

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 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 elevate 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,