Sr. Manager, Global Clinical Supply Operations

Role Summary

Senior Manager, Global Clinical Supply Operations responsible for designing and executing global clinical supply strategies across multiple development phases. Lead the development and implementation of IRT systems, oversee Pharmacy and Dosing Manual development, and ensure accurate maintenance of TMF documents. Collaborate with internal teams and external CROs/CMOs to drive operational excellence and inspection readiness. Hybrid role requiring on-site work at a Sarepta facility in the United States and occasional in-person events.

Responsibilities

• Participate in Clinical Trial Team meetings to gather information for clinical drug supply planning, including FPI readiness dates, labeling/packaging requirements, country lists, forecasts, and enrollment rates.
• Lead the creation, translation, and approval process for clinical labels across global trials.
• Define and implement IRT requirements in partnership with Clinical Operations and CROs.
• Ensure accurate archiving and maintenance of TMF documents and support inspection readiness activities.
• Collaborate on Pharmacy and Dosing Manual development with Clinical Operations.
• Support inspection readiness activities, including mock audits and BIMO clinical trial inspections.
• Develop detailed packaging and shipping requirements and coordinate execution with Supply Operations and Logistics.
• Provide timely inventory and supply updates to Clinical Trial Teams.
• Prepare quotes and manage relationships with contract manufacturers.
• Oversee clinical supply chain budgets, purchase orders, and invoice processing.
• Review and approve technical manufacturing documents such as production records, distribution instructions, specifications, and SOPs.
• Collaborate with labeling vendors and CMOs to manage project plans and requirements.
• Coordinate the return and destruction of IMPs from clinical sites and distribution depots.
• Manage temperature excursions and ensure compliance for each study.
• Partner with QA/QP to enable release of clinical trial materials.

Qualifications

• BS/BA/BPharm/PharmD or equivalent with 8–12 years of experience in clinical supply chain management.
• Proven experience in global clinical labeling and packaging.
• Hands-on experience with IRT setup and management.
• Strong knowledge of TMF, Pharmacy and Dosing Manual development.
• Expertise in temperature-controlled shipments and excursion management.
• Experience working with CROs, CMOs and third-party vendors.
• Proficiency in planning and tracking tools such as Tableau, Smartsheet, or similar platforms for forecasting, reporting, and project management.
• Excellent communication, problem-solving, and cross-functional collaboration skills.
• Ability to travel domestically and internationally.

Additional Requirements

• Travel domestically and internationally as needed.
• Hybrid work arrangement with on-site presence required at a Sarepta facility in the United States and occasional in-person events.