Senior Director, Clinical Development

Sarepta Therapeutics Inc.•Cambridge, MA

34d•Hybrid

About The Position

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. 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.

Requirements

Doctorate degree: MD, Ph.D. or Pharm D in a related area
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

Responsibilities

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