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 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

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 training etc.)
• Up to 4 direct reports consisting of CTAs COLs Sr. COLs

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
• Bachelors degree in health sciences or related field
• Minimum of 7 years experience in clinical research with at least 5 years experience in study management with strong experience with study phases I-IV global trials and with complex trial designs
• Program-level experience preferred. Rare disease study management is recommended. Line management experience required

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.