Manager, Clinical Supply Chain

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 womens 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 develo
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pment to bring novel therapies to patients sooner. For more information on SMPA visit our website 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 studies to ensure clinical supply systems databases trackers planning tools inventory records and information shared internally and externally remain accurate complete and reliable.
Represent Clinical Supply Chain in IRT/

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