Sr. Manager, Global Clinical Supply Operations

Role Summary

As Senior Manager, Global Clinical Supply Operations, you will play a critical role in ensuring the success of global clinical studies across multiple phases of development. You’ll design and execute clinical supply strategies that enable timely, compliant, and efficient delivery of investigational products worldwide. This position requires strong analytical skills to translate complex trial designs into actionable supply plans, as well as deep knowledge of clinical trial operations. Additionally, you will lead the development and implementation of IRT systems, oversee the creation of Pharmacy and Dosing Manuals, and ensure accurate maintenance and archiving of essential documents within the Trial Master File (TMF). You will collaborate closely with internal cross-functional teams and external CROs and CMOs to drive operational excellence and inspection readiness.

Responsibilities

• Participate in Clinical Trial Team meetings to gather critical information for clinical drug supply planning, including FPI readiness dates, labeling and 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.

Education

• Bachelor’s degree in Pharmacy, Life Sciences, or related field (or equivalent).

Additional Requirements

• Hybrid work arrangement, on-site at a Sarepta facility in the United States and occasional in-person events as needed.