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 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.

Supervisory Responsibilities and Job Complexity

• 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.

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.

Travel Requirements:

Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.

Mental/Physical Requirements:

Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

The base salary range for this role is

$131,400.00 - $164,200.00

Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus 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.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at [email protected]. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.