Senior Director, Clinical Development

The individual in this role will provide scientific and strategic leadership for multiple late-stage clinical programs within Sarepta Therapeutics, including anticipated regulatory interactions. Under the direction of the Head of Clinical Development, the role will lead projects, assist with business development as needed, and foster innovation and external collaboration.

Responsibilities:
- Supervise one or more direct reports and lead the clinical development team for a product
- Lead the design and execution of projects supporting clinical research programs
- Lead the clinical study team in protocol development, protocol monitoring, study reports, training documents, and other clinical/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
- Work effectively across multiple projects and teams
- Stay current on regulations and guidelines for the therapeutic area and relevant scientific advances
- Cultivate relationships with external partners (clinical investigators, clinicians, scientists) for innovation and business development
- Assist with due diligence for business development opportunities
- May require travel to field sites, meetings, and conferences

Qualifications:
- Doctorate degree (MD or DO preferred)
- Experience as a practicing physician required
- At least 15 years of clinical/research experience, including 5 years of industry experience

Skills/Experience:
- Ability to analyze and interpret 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, persistence
- High level of organizational and project management skills
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators

Benefits (if explicitly stated):
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers

Application instructions:
- Not specified