Clinical Supply Chain Lead, End-to-End Trials

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 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