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

Sarepta Therapeutics; Cambridge (MA); Hybrid; USD 161,000 - 201,000; Full time

Benefits offered by this job

Wellness programs

Financial wellness

Caregiver support

Job summary

Sarepta Therapeutics is seeking an Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility. You will lead cross-functional teams to drive feasibility and study start-up strategies across Sarepta’s clinical programs.

This hybrid role requires deep operational experience, strong leadership, and a track record in managing timelines, vendors, and budgets to accelerate study execution in a patient-focused biotech environment.

Qualifications

• BA/BS degree in a related field.
• 10+ years experience in pharmaceutical/biotech clinical operations or project management.
• Experience in feasibility, study start-up, and budget planning.
• Experience with managing CROs and vendors.
• Regulatory knowledge including ICH and GCPs.

Responsibilities

• Develop and implement feasibility and start-up strategies for Sarepta clinical studies.
• Gather cross-functional country-level input to inform feasibility strategies.
• Manage integrated feasibility and site start-up timelines and report progress.
• Lead meetings with study leads, CROs, and internal teams to review feasibility data.
• Oversee study feasibility activities including country, site, and investigator selection.
• Create reporting tools to measure ongoing activities and KPIs.

Skills

Clinical operations

Project management

Budget planning

Vendor management

Cross-functional leadership

Regulatory knowledge

Analytical reasoning

Presentation skills

Education

BA/BS degree in a related field

Tools

CTMS

Job description

Why Sarepta? Why Now?

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold a leadership position in Duchenne Muscular Dystrophy and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. Our next-generation siRNA platform is focused on chronically administered therapies for neurodegenerative and pulmonary diseases. 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

We are seeking an associate director-level candidate with clinical operations experience, with specific expertise in feasibility and study start-up, who is interested in applying their experience to develop, build out, and implement innovative feasibility and study start-up activities within Sarepta that positively impacts our clinical programs. The Associate Director, Clinical Operations Program Lead, Study Start-up and Feasibility will report to the Director, Patient Recruitment and Start-Up Strategy and lead a team to drive the strategy and implementation of country and site feasibility for our studies and support the internalization of country and site feasibility. Additionally, the candidate will work with early research and other stakeholders to build out the oversight model for Feasibility & Study Start-up. The candidate will drive the study start-up activities and be responsible for oversight of timelines and goals with respect to our clinical studies. The candidate will be responsible for 1) directing and overseeing the success of Sarepta’s clinical trial feasibility process, 2) leading the development of feasibility and start-up strategies including study-specific plans, 3) directing and overseeing the success of the Sarepta’s clinical trial start-up activities, and 4) working with both internal and external vendors. This is a highly cross-functional position, collaborating with internal teams, CROs, and vendors. The candidate must be comfortable working directly with clinical trial sites. The contribution of the candidate directly supports the goals of the Development Operations organization under R&D. This is a great opportunity for an individual with an operational background and innovative mindset to help us accelerate study execution to support Sarepta’s goal of Patient’s First.

The Opportunity to Make a Difference

Primary Responsibilities Include:

• Develop and implement the feasibility and start-up strategies to support the success of Sarepta clinical studies.
• Gather cross-functional, country-level input to inform robust feasibility strategies.
• Develop and manage integrated feasibility and site start-up timelines, and report on progress, including plans to address potential timing risks or gaps.
• Establish study specific meeting series to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO.
• The candidate will report metrics to larger teams including senior management.
• Lead calls with Sarepta and the CRO to manage feasibility and study start-up activities and ensure the study timelines are achieved.
• Oversee study feasibility activities including country, site, and investigator selection for participation in Sarepta-lead studies.
• Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
• Provide guidance and mentoring to junior members of the Study Start-up and Feasibility Team.
• Create reporting tools to measure ongoing activities and other key performance, quality, and effectiveness indicators.
• Partner with Clinical Operations and CRO teams, and other key stakeholders to implement innovative feasibility efforts including collection of data within CTMS.
• Support and or lead the development of Charters or SOPs as it relates to Study Start-up and Feasibility.
• May have direct reports.

More about You Desired Education and Skills:

• BA / BS degree in a related field
• 10+ years related experience in the pharmaceutical or biotech industry within a clinical operations or project management role or similar
• Experience in clinical study budget planning, and program implementation
• Experience with both direct line management and dotted line reporting
• Experience in developing feasibility questionnaires
• Experience with protocol and ICF development and review
• Experience in clinical study start-up
• Experience with rare disease / difficult to recruit populations a plus
• Experience identifying and managing multiple CROs, vendors, budgets, KPIs
• Comprehensive regulatory knowledge, including ICH and GCPs
• Exceptional organizational skills and ability to deal with competing priorities
• Strong analytical reasoning and problem-solving ability
• Excellent PowerPoint slide development and presentation skills
• Ability to multi-task, work independently and as part of a multidisciplinary team, exercise sound judgement and elevate issues when necessary

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,

#LI-Hybrid This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $160,800 - $201,000 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.

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.