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 development 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.

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; Masters 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

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.

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