Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development responsible for scientific and strategic leadership across multiple late-stage clinical programs at Sarepta Therapeutics. Leads clinical development activities, including regulatory interactions, and oversees projects under the Head of Clinical Development. Requires a Doctorate (MD, PhD, or PharmD) with proven industry experience and a passion to advance Sarepta’s pipeline. Location: United States; hybrid work arrangement with occasional travel to field sites, meetings, and conferences.

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 and guidelines for the therapeutic area and scientific advances
• Cultivates relationships with external partners such as clinical investigators and scientists to support innovation and business development
• Assists with due diligence related to business development opportunities
• May require travel to field sites, internal and external meetings and conferences

Qualifications

• Doctorate degree: MD, Ph.D. 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); 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 clinical development leadership
• Regulatory affairs and interactions with regulatory agencies
• Cross-functional collaboration and matrix leadership
• External partner relationship management
• Clinical study design, monitoring, and reporting
• Biostatistics familiarity; data interpretation
• Exceptional communication and organizational skills

Education

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

Additional Requirements

• Hybrid work arrangement in the United States; periodic travel to field sites and meetings may be required