Senior Director, Clinical Development

Role Summary

Reporting to the Head of Clinical Development, this role provides scientific and strategic leadership for activities in late-stage clinical development across Sarepta Therapeutics, including multiple anticipated regulatory interactions. The Senior Director will lead projects under the direction of the Head of Clinical Development, assist to support business development as needed, and foster innovation and external collaboration. The ideal candidate holds a doctorate (MD, PhD, or PharmD) and has 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
• Stays up to date on regulations, guidelines for the therapeutic area, and scientific advances internal and external to Sarepta
• Cultivates relationships with external partners such as clinical investigators, clinicians, and scientists in support of innovation and business development
• Assists 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

• 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) and 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, Ph.D. or PharmD in a related area

Skills

• Scientific leadership and strategic program management
• Clinical data analysis and interpretation (safety and efficacy)
• Regulatory knowledge for clinical studies and GCP
• Biostatistics familiarity
• Stakeholder management and collaboration across functions
• External relationship building with investigators and scientists
• Strong communication and presentation skills

Additional Requirements

• May require travel to field sites and conferences
• Hybrid work arrangement; on-site presence at Sarepta facilities in the U.S. and participation in in-person company events as needed