Sr. Manager, Global Clinical Supply Operations

Why Sarepta Why Now

The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.

What Sarepta Offers

At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• Financial Wellness

• Support for Caregivers
  

For a full list of our comprehensive benefits see our website: Importance of the Role

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. Youll 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.

The Opportunity to Make a Difference

The Opportunity to Make a Difference

• 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.

More about You

More about You

• BS/BA/BPharm/PharmD or equivalent with 812 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.

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

#LI-Hybrid

#LI-CM1

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $132000 - $165000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas compensation philosophy and considers factors including but not limited to education training experience external market conditions criticality of role and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.