Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development will provide scientific and strategic leadership for late-stage clinical programs within Sarepta Therapeutics, including multiple anticipated regulatory interactions. The role leads projects under the direction of the Head of Clinical Development, supports business development as needed, and fosters innovation and external collaboration. Ideal candidates hold a doctorate (MD, PhD, or PharmD) with proven success in clinical development and a passion to advance Sarepta's pipeline.

Responsibilities

• Supervise one or more direct reports and lead the clinical development team for a product
• Lead the design and execution of projects conducted in support of clinical research programs
• Lead the clinical study team in protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents
• Lead the clinical development product team to facilitate clinical development goals and achievement of study quality metrics
• Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with project teams and stakeholders
• Work across multiple projects and teams
• Stay up to date on regulations and guidelines for the therapeutic area and scientific advances
• Cultivate relationships with external partners such as clinical investigators, clinicians, and scientists to support innovation and business development
• Assist with due diligence related to business development opportunities
• May require travel to field sites, internal and external meetings and conferences

Qualifications

• Doctorate degree: MD, PhD, or PharmD 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

Education

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

Skills

• Leadership and people management
• Clinical development strategy and program execution
• Biostatistics literacy and data interpretation
• GCP/regulatory knowledge for clinical studies
• Strong written and verbal communication
• Cross-functional collaboration and external partnership development
• Project management and organizational skills

Additional Requirements

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