Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development will provide scientific and strategic leadership for late-stage clinical development programs, manage clinical study teams, and collaborate across internal and external partners. The role supports regulatory interactions, contributes to business development activities, and drives innovation within Sarepta’s pipeline. This is a hybrid role based in the United States, with on-site work at Sarepta facilities and occasional travel.

Responsibilities

• Supervise one or more direct reports and lead the clinical development team for a product
• Design and execute projects in support of clinical research programs
• Lead the clinical study team in protocol development, monitoring, study reports, training documents, and other clinical/regulatory materials
• Lead the clinical development product team to achieve study quality metrics
• Contribute to investigator and advisory board meetings in collaboration with project teams
• Collaborate across multiple projects and teams and stay current on regulatory guidelines and scientific advances
• Cultivate relationships with external partners such as clinical investigators and scientists to support innovation and business development
• Assist with due diligence for business development opportunities
• Travel to field sites, meetings, and conferences as needed

Qualifications

• Doctorate degree: MD, PhD, or PharmD
• 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
• Strong organizational and project management skills
• Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators

Education

• Doctorate degree: MD, PhD, or PharmD in a related area

Additional Requirements

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