[Hiring] Clinical Supply Chain Manager @Sumitomo Pharma America, Inc.

Role Description

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.

Qualifications

• 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.
• 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.

Requirements

• 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; experience with clinical supply, inventory, forecasting, project management, and financial systems preferred.
• APICS certification, including CPIM, CLTD, or CSCP, is preferred.

Benefits

• Base salary range: $131,400.00 - $164,200.00.
• Opportunity for merit-based salary increases.
• Short incentive plan participation.
• Eligibility for our 401(k) plan.
• Medical, dental, vision, life and disability insurances.
• Robust time-off policy including flexible paid time off, 11 paid holidays, and 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.

Working Conditions and Other Requirements

• 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.