Senior Director, Clinical Development

Role Summary

The Senior Director, Clinical Development provides scientific and strategic leadership for late-stage clinical development programs, including anticipated regulatory interactions. Reporting to the Head of Clinical Development, the role leads projects, supports business development activities as needed, and fosters external collaboration to advance Sarepta’s pipeline. The ideal candidate has a doctoral degree and 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
• Stays up to date on regulations and guidelines for the therapeutic area and scientific advances both internal and external to Sarepta
• Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists to support innovation and business development
• Assists with due diligence for business development opportunities
• May require travel to field sites, internal and external meetings and conferences

Qualifications

• 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) with 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

Skills

• Strategic clinical development leadership
• Cross-functional collaboration and stakeholder management
• Strong analytical and data interpretation capabilities
• Effective scientific and regulatory communication

Education

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

Additional Requirements

• Hybrid work arrangement; on-site presence at Sarepta facilities in the United States and attendance at Company-sponsored in-person events as needed
• May require travel to field sites, internal and external meetings and conferences