Note: The job is a remote job and is open to candidates in USA. Sumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs across oncology, urology, women's health, rare diseases, cell and gene therapies, and CNS. The Manager, Clinical Supply Chain oversees end-to-end clinical supply planning, packaging, labeling, inventory, distribution, vendor coordination, risk management, and compliance for assigned clinical studies. The role collaborates with cross-functional teams and external partners to ensure timely availability of investigational product and effective study execution.
Responsibilities
- 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
- 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
- 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
- No immediate line management responsibility. May provide functional oversight to contractors, consultants, temporary personnel, or junior team members and may lead cross-functional workstreams
- Works on matters of diverse scope that require evaluation of study assumptions, inventory, manufacturing and packaging schedules, enrollment activity, expiry limitations, distribution requirements, and vendor capabilities
- Exercises judgment in selecting planning methods, supply strategies, packaging approaches, inventory parameters, distribution solutions, and risk mitigation measures
- Independently manages assigned clinical supply activities with moderate supervision and escalates significant risks, compliance matters, budget concerns, or timeline issues as appropriate
- Operates in a time-sensitive environment in which supply decisions may affect study start-up, enrollment, dosing continuity, site operations, cost, and overall study execution
- Works in a fast-paced environment that requires management of multiple priorities, studies, vendors, and deadlines
- Must be able to work effectively with geographically dispersed teams and external partners
- Business needs may require participation in meetings outside normal working hours, and occasional business travel may be required
- Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed
Skills
- BS/BA degree in life sciences, business, supply chain management, pharmaceutical sciences, or a related discipline required
- Equivalent combination of education, training, and relevant professional experience may be considered
- 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
- 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 strategies
- Strong project management, risk management, vendor management, financial awareness, organizational, analytical, and problem-solving skills
- Excellent written and verbal communication skills and the ability to build alignment in cross-functional and matrixed teams
- Ability to work independently, exercise appropriate judgment, and manage multiple studies, vendors, timelines, and competing priorities
- Strong attention to data integrity, documentation accuracy, product accountability, patient safety, and regulatory compliance
- Proficient knowledge of Microsoft Excel, PowerPoint, and Project required
- Must be able to work effectively with geographically dispersed teams and external partners
- Must be able to travel domestically and internationally as needed
- Excellent written and oral communication skills required
- Requires ability to use a personal computer for extended periods of time
- Master's degree preferred
- 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
- Experience with clinical supply, inventory, forecasting, project management, and financial systems preferred
- APICS certification, including CPIM, CLTD, or CSCP, is preferred
Benefits
- Opportunity for merit-based salary increases
- Short incentive plan participation
- Eligibility for the 401(k) plan
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Disability insurance
- Leaves provided in line with your work state
- Flexible paid time off
- 11 paid holidays
- Additional time off for a shut-down period during the last week of December
- 80 hours of paid sick time upon hire and each year thereafter
- Primarily remote role with periodic on-site meetings in office
Company Overview
Company H1B Sponsorship