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, 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 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/RTSM design, testing, implementation, maintenance, and review to ensure randomization, dispensing, lot management, expiry management, inventory, and resupply functionality support protocol requirements and supply strategy. • Oversee CTM suppliers, CMOs, contract packaging organizations, depots, comparator sourcing providers, logistics providers, IRT vendors, and contracted resources, including work assignments, deliverables, timelines, performance, quality expectations, scopes of work, and issue resolution. • Manage vendor and financial activities, including RFP support, contracts, purchase orders, work orders, change orders, invoices, accruals, CSC budget and forecast planning, and proposal/invoice review. • Collaborate with Clinical Operations, CMC, Regulatory Affairs, QA, PDM, Manufacturing, Finance, Procurement, Legal, Trade Compliance & Logistics, SMPA external partners, CMOs, and vendors to advance clinical programs, ensure supply readiness, support study teams, and communicate plans, timelines, risks, decisions, and actions. • Contribute to the generation, refinement, and maintenance of Clinical Operations and Clinical Supply Chain infrastructure, including processes, tools, templates, trackers, and ways of working that support compliant and efficient study execution. PROFESSIONAL EXPERIENCE/QUALIFICATIONS: Education • BS/BA degree in life sciences, business, supply chain management, pharmaceutical sciences, or a related discipline required; Master's degree preferred. • Equivalent combination of education, training, and relevant professional experience may be considered. Professional Experience • Minimum of five to seven years of relevant life sciences industry experience, including project management, pharmaceutical development, clinical supply management, and/or clinical trials coordination. • At least three years of experience in Clinical Supplies Management required. • Demonstrated experience managing clinical trial materials across planning, packaging, labeling, inventory, distribution, reconciliation, and vendor coordination. • Experience supporting domestic and global clinical studies through external CMOs, packaging vendors, depots, logistics providers, and contract resources is preferred. • Experience supporting vendor financial activities, including budgets, purchase orders, work orders, invoice review, accruals, and financial tracking, is preferred. Knowledge, Skills, and Abilities • Working knowledge of clinical development, clinical protocols, study design, enrollment assumptions, dosing requirements, site activation, manufacturing, packaging, release, distribution, and study execution. • Knowledge of clinical packaging, labeling, batch documentation, product accountability, reconciliation, and inspection-ready documentation practices. • Working knowledge of IRT/RTSM systems used to manage randomization, dispensing, inventory, resupply, lot assignment, and expiry information. • Working knowledge of cGMP, GCP, GDP, ICH, FDA, U.S. investigational product requirements, applicable international regulations, local requirements, company SOPs, and guidance documents. • Ability to translate protocol requirements and operational assumptions into practical, compliant, and cost-effective supply s