Senior Clinical Operations Lead

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. 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

• Oversee 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 stakeholders, 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

• 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 relat