Associate Director, Clinical Operations Program Lead, Study Start-up & Feasibility

Sarepta Therapeutics • Cambridge, MA

12d • Hybrid

About The Position

Sarepta is seeking an associate director-level clinical operations professional with expertise in feasibility and study start-up to develop, build, 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, supports internalizing those activities, and works with early research and other stakeholders to establish the oversight model for Feasibility & Study Start-up.

The position drives study start-up activities and oversees timelines and goals for clinical studies. It directs Sarepta’s clinical trial feasibility and start-up processes, leads feasibility and start-up strategies and study-specific plans, and works with internal teams, CROs, vendors, and clinical trial sites. The role reports to the Director, Patient Recruitment and Start-Up Strategy and supports the Development Operations organization within R&D. It may have direct reports.

This is a hybrid position. The employee is expected to work on site at one of Sarepta’s U.S. facilities and/or attend company-sponsored in-person events from time to time. Candidates must be authorized to work in the United States. The targeted salary range is $160,800–$201,000 per year.

Requirements

• BA/BS degree in a related field.
• 10+ years of related experience in the pharmaceutical or biotech industry in 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.
• 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 United States.

Nice To Haves

• Experience with rare diseases or difficult-to-recruit populations.
• Experience identifying and managing multiple CROs, vendors, budgets, and KPIs.

Responsibilities

• Develop and implement feasibility and 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 create plans to address timing risks or gaps.
• Establish study-specific meeting series to review feasibility data and start-up activities with study leads, MSLs, and the CRO.
• Report metrics to larger teams, including senior management.
• Lead calls with Sarepta and CRO teams to manage feasibility and study start-up activities and ensure study timelines are achieved.
• Oversee study feasibility activities, including country, site, and investigator selection for Sarepta-led studies.
• Develop new 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 data collection within CTMS.
• Support or lead the development of charters or SOPs related to Study Start-up and Feasibility.

Benefits

• Competitive compensation and benefit package.
• Benefits and work-life resources supporting physical and emotional wellness, financial wellness, and caregivers.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior