Senior 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: https://www.sarepta.com/join-us
 

The Importance of the Role

The Senior Clinical Operations Lead, Clinical Operations manages all aspects of assigned clinical trials as well as the study project plan, including timeline, budget, and vendors and is expected to conduct large studies of high complexity. The Sr. COL will provide leadership and potentially line management within Clinical Operations and guidance with regards to operational deliverables

The Opportunity to Make a Difference

• Oversees Clinical Research Organizations (CROs), vendors and consultants involved with the clinical trials
• Serves as the point of contact for protocol execution and leads the Clinical Trial Team (CTT)
• Mentors junior team members and ensures alignment with any supporting Clinical Operations 
Leads (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 Clinical Operations Program Lead (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 
• 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 
• Participates in operational improvement initiatives (e.g., SOP development, training, etc.)
 

More about You

Desired Education and Skills: 
• Experience in management of CROs, vendors and consultants
• Documented training, knowledge, and application of current FDA/EU Regulations, GCP and ICH guidelines for patient registries and studies
• Experience developing trial plans including site management, risk mitigation strategies, trial budgets and program-level budgets
• Proficient written and verbal communication skills
• Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills
• Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project
• Position may require some travel
• Bachelor’s degree in health sciences or related field
• Minimum of 7+ years’ experience in clinical research with at least 4 years’ experience in study management with strong experience with study phases I-IV, global trials, and with complex trial designs. Rare disease study management is recommended.

What Now?

We’re always looking for solution-oriented, critical thinkers.

So, if you’re 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-OnsiteThis position requires work on site at one of Sarepta’s facilities in the United States.The targeted salary range for this position is $152,400 - $190,500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s 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.