Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development. Reporting to the Head of Clinical Development, this role provides scientific and strategic leadership for activities in late-stage clinical development across Sarepta Therapeutics, including anticipated regulatory interactions. The position leads projects, supports business development, and fosters innovation and external collaboration. The ideal candidate holds a doctorate (MD, PhD or PharmD) and has a proven track record in clinical development within industry.

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

Qualifications

• Doctorate degree: MD, Ph.D. or PharmD 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

Education

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

Additional Requirements

• May require travel to field sites, internal and external meetings and conferences