Associate Director, Clinical Operations Lead, Study Start-up & Feasibility
Job Description
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 diseases. 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 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 feasibility and study start-up across all clinical programs.The Opportunity to Make a Difference
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 impact 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 will 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. The candidate will drive 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, and (3) directing and overseeing the success of Sarepta’s clinical trial start-up activities.
This is a highly cross-functional position, requiring collaboration 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.
More about You
Primary Responsibilities Include:
- Develop and implement feasibility and start-up strategies to support the success of Sarepta’s clinical studies.
- Oversee study feasibility activities, including country, site, and investigator selection for participation in 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 meetings to review clinical trial feasibility data and start-up activities with study leads, MSLs, and the CRO; report metrics to broader teams, including senior management.
- Lead calls with Sarepta and CRO partners to manage feasibility and study start-up activities and ensure study timelines are achieved.
- Foster a culture of innovation by developing new ideas and programs to advance feasibility and support departmental growth.
- Provide guidance and mentorship to junior members of the Study Start-up and Feasibility team.
- Create reporting tools to measure ongoing activities, as well as key performance, quality, and effectiveness indicators.
- Partner with Clinical Operations, CRO teams, and other key stakeholders to implement innovative feasibility initiatives, including data collection within CTMS.
- Support and/or lead the development of charters and SOPs related to Study Start-up and Feasibility.
- May have direct reports.
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 escalate 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, then we encourage you to apply.