Senior Director, Clinical Development

Role Summary

Reporting to the Head of Clinical Development, this role will work on multiple late-stage clinical programs to provide scientific and strategic leadership for activities in clinical development, including regulatory interactions. The role will lead projects under the Head of Clinical Development, assist to support business development, and foster innovation and external collaboration. The ideal candidate holds a doctorate degree (MD, PhD or PharmD) with proven success in clinical development through industry experience and a passion to advance Sarepta's pipeline.

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

Qualifications

• Required: Experience as a practicing physician
• Preferred: Doctorate degree in MD or DO
• 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

Skills

• Strategic leadership and governance of late-stage clinical development programs
• Cross-functional collaboration across clinical operations, regulatory, QA and external partners

Additional Requirements

• Hybrid role requiring on-site work at a Sarepta facility in the United States and/or attendance at company-sponsored in-person events
• May require travel to field sites, internal and external meetings and conferences