Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development will provide scientific and strategic leadership for late-stage clinical development programs at Sarepta Therapeutics. The role leads clinical development teams, drives protocol design and execution, and coordinates regulatory interactions, while supporting business development and external collaboration. The position reports to the Head of Clinical Development and requires collaboration across multiple projects and external partners. The role is hybrid in the United States, with on-site work at Sarepta facilities and periodic attendance at company-sponsored events.

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

• Preferred: Doctorate degree: MD or DO
• Required: Experience as a practicing physician
• Required: At least 15 years of clinical/research experience including 5 years of industry experience
• Required: Experience in analysis and interpretation of clinical data (safety and efficacy) and a working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
• Required: Ability to make independent, timely, and appropriate decisions
• Required: Ability to work collaboratively in a fast-paced, team-based matrix environment
• Required: Excellent written and verbal communication skills
• Required: Intellectual curiosity, flexibility, and persistence
• Required: High level of organizational and project management skills
• Required: Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators

Skills

• Excellent written and verbal communication skills
• Intellectual curiosity, flexibility, and persistence
• High level of organizational and project management skills
• Ability to work collaboratively in a fast-paced, team-based matrix environment

Additional Requirements

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