Associate Director, Clinical Operations Lead

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 diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

We're 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:

The Importance of the Role

The Associate Director, Clinical Operations Lead, is responsible for the planning, implementation, conduct, and oversight of clinical operations for assigned studies or program. This individual is expected to provide leadership as well as line management within Development Operations and guidance with regards to operational deliverables. The AD COL may lead complex studies with the support of one or more Clinical Operations Leads (COLs) and/or may be responsible for project oversight across studies within a program.

The Opportunity to Make a Difference

* Serve as the subject matter expert within clinical operations for the planning and execution of studies across all phases

* May lead complex studies with the support of one or more COLs, or may provide project oversight to one or more studies on a large program

* Oversees Clinical Research Organizations (CROs), vendors and consultants involved with the clinical trials

* Serves as the point of contact for protocol execution

* May lead the Clinical Trial Team (CTT) and/or may participate in the program Clinical Sub Team

* May support the Clinical Operations Program Lead (COPL) to operationalize and execute the Clinical Development Plan (CDP)

* Oversees junior team members and ensures alignment with any supporting COLs assigned to studies

* Establishes study timelines in line with company goals and ensures accurate tracking and reporting of study metrics and progress through completion of study dashboards

* Works cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated to the COPL

* Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs

* Develops, reviews and/or consults on reports and clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates

* Responsible for communication and escalation of study related issues to the COPL

* Provides enrollment forecasting to internal stakeholder, such as Clinical Supply, at agreed upon frequency

* Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance with ICH/GCP and company SOPs as well as ensuring all appropriate documents are filed, or delegates activity with oversight

* Participates and responds to Quality Assurance and/or regulatory authority inspection audits

* In conjunction with CRO and appropriate internal stakeholders, facilitates the development of trial budgets and execution of clinical trial agreements and other relevant documents

* Manages the clinical trial budget and provides financial reporting and projections to Finance

* Leads creation of scope of work and budgets and escalates vendor performance issues to COPL and Procurement as necessary

* May serve as an escalation point for more clinical operations team study team members internally and with vendors

* Assume leadership role in operational improvement initiatives (e.g., SOP development,…