Associate Director, Clinical Operations Program Lead, Study Start-up & Feasibility
About The Position
Sarepta is seeking an associate director-level clinical operations professional with expertise in feasibility and study start-up to develop, build out, and implement innovative activities that support its clinical programs. The role leads a team responsible for the strategy and implementation of country- and site-level feasibility and supports internalizing these activities. The position also works with early research and other stakeholders to establish an oversight model for Feasibility & Study Start-up, and oversees study start-up timelines and goals. The role directs Sarepta’s clinical trial feasibility process and start-up activities, develops feasibility and start-up strategies—including study-specific plans—and works with internal and external vendors. It is highly cross-functional, involving internal teams, CROs, vendors, and direct engagement with clinical trial sites. The position contributes to the Development Operations organization under R&D and supports Sarepta’s patient-first goals. The position reports to the Director, Patient Recruitment and Start-Up Strategy. It may have direct reports and provides guidance and mentoring to junior team members. The role is hybrid, with on-site work at a Sarepta facility in the United States and/or attendance at company-sponsored in-person events from time to time. Candidates must be authorized to work in the U.S.
Requirements
- BA/BS degree in a related field.
- 10+ years of related experience in the pharmaceutical or biotech industry within clinical operations, project management, or a similar role.
- Experience in clinical study budget planning and program implementation.
- Experience with direct line management and dotted-line reporting.
- Experience developing feasibility questionnaires.
- Experience with protocol and ICF development and review.
- Experience in clinical study start-up.
- Experience identifying and managing multiple CROs, vendors, budgets, and KPIs.
- Comprehensive regulatory knowledge, including ICH and GCPs.
- Exceptional organizational skills and ability to manage competing priorities.
- Strong analytical reasoning and problem-solving ability.
- Excellent PowerPoint slide development and presentation skills.
- Ability to multitask, work independently and as part of a multidisciplinary team, exercise sound judgment, and escalate issues when necessary.
- Must be authorized to work in the U.S.
Nice To Haves
- Experience with rare disease or difficult-to-recruit populations.
Responsibilities
- Develop and implement feasibility and study start-up strategies to support Sarepta clinical studies.
- Gather cross-functional, country-level input to inform feasibility strategies.
- Develop and manage integrated feasibility and site start-up timelines, report progress, and plan for potential timing risks or gaps.
- Establish study-specific meetings to review feasibility data and start-up activities with study leads, MSLs, and the CRO; report metrics to broader teams, including senior management.
- Lead Sarepta and CRO calls to manage feasibility and start-up activities and help ensure study timelines are achieved.
- Oversee country, site, and investigator selection for Sarepta-led studies.
- Develop ideas and programs to advance feasibility and support departmental growth.
- Guide and mentor junior members of the Study Start-up and Feasibility Team.
- Create reporting tools to measure ongoing activities and key performance, quality, and effectiveness indicators.
- Partner with Clinical Operations, CRO teams, and other stakeholders to implement innovative feasibility efforts, including collecting data within CTMS.
- Support or lead the development of Charters or SOPs related to Study Start-up and Feasibility.
- Work with internal and external vendors.
Benefits
- Competitive compensation and benefit package.
- Benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
