Senior Director, Clinical Development

Benefits

Additional Information

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 Reporting to the Head of Clinical Development, the individual in this role will work on multiple late stage clinical programs within Sarepta Therapeutics to provide scientific and strategic leadership for activities in clinical development, including multiple anticipated regulatory interactions. In addition, this individual will lead projects under the direction of the Head of Clinical Development, assist, as needed, to support business development, and foster innovation and external collaboration. The ideal candidate has a doctorate degree (MD, PhD or PharmD) and proven success in clinical development through industry experience and a passion to further the Sarepta pipeline. The Opportunity to Make a Difference Supervises one or more direct reports and leads the clinical development team for a product Leads the design and execution of projects conducted in support of clinical research programs Leads the clinical study team in protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents Leads the clinical development product team to facilitate clinical development goals and achievement of study quality metrics Contributes to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders Can effectively work across multiple projects and teams up to date on current information regarding regulations and guidelines for their therapeutic area and scientific advances in the relevant field both internal and external to Sarepta Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development Will assist with the due diligence process as it pertains to business development opportunities May require travel to field sites, internal and external meetings and conferences More about You Doctorate degree: MD or DO preferred Experience as a practicing physician required At least 15 years of clinical/research experience including 5 years of industry experience Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies Ability to make independent, timely, and appropriate decisions Ability to work collaboratively in a fast-paced, team-based matrix environment Excellent written and verbal communication skills Intellectual curiosity, flexibility, and persistence High level of organizational and project management skills Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators 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. #LI-Hybrid #LI-ES1 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 $222,400 - $278,000 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/Affirma