Senior Director, Clinical Development

Role Summary

Reporting to the Head of Clinical Development, the individual in this role will work on multiple late stage clinical programs within Sarepta Therapeutics to provide scientific and strategic leadership for activities in clinical development, including multiple anticipated regulatory interactions. In addition, this individual will lead projects under the direction of the Head of Clinical Development, assist, as needed, to support business development, and foster innovation and external collaboration. The ideal candidate has a doctorate degree (MD, PhD or PharmD) and proven success in clinical development through industry experience and a passion to further the Sarepta 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
• May require travel to field sites, internal and external meetings and conferences

Education

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

Qualifications

• 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 in clinical development
• Cross-functional collaboration
• Regulatory and compliance knowledge (GCP, regulatory requirements)
• Biostatistics interpretation
• Effective communication and relationship building with external partners
• Project and people management

Additional Requirements

• May require travel to field sites, internal and external meetings and conferences
• Hybrid position; on-site work at Sarepta facilities in the United States and/or attendance at Company-sponsored in-person events from time to time