Senior Director, Clinical Development
Sarepta Therapeutics
5 hours ago
Remote friendly (Atlanta, GA)
United States
$280,000 - $350,000 USD yearly
Clinical Research and Development
The Role (Reporting to Head of Clinical Development)
- Provide scientific and strategic leadership for multiple late-stage clinical programs, including anticipated regulatory interactions.
- Lead projects supporting clinical research programs; assist with business development as needed; foster innovation and external collaboration.
Responsibilities
- Supervise one or more direct reports and lead the clinical development team for a product.
- Lead design and execution of projects for clinical research programs.
- Lead clinical study team activities: protocol development, protocol monitoring, study reports, training documents, and other clinical/regulatory documents.
- Facilitate clinical development goals and achievement of study quality metrics.
- Contribute to preparation and execution of investigator and advisory board meetings.
- Work across multiple projects and teams; stay current on regulations/guidelines and scientific advances.
- Build relationships with external partners (clinical investigators, clinicians, scientists).
- Assist with due diligence for business development opportunities.
- May require travel to field sites, meetings, and conferences.
Qualifications
- Doctorate degree (MD/DO preferred); practicing physician experience required.
- 15+ years clinical/research experience, including 5 years industry experience.
- Experience interpreting clinical data (safety/efficacy); knowledge of biostatistics, GCP, and regulatory requirements.
Skills
- Independent, timely decision-making; strong written/verbal communication.
- Collaboration in a fast-paced matrix environment; organizational/project management skills.
Benefits (as stated)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions
- If you’re solution-oriented and comfortable with ambiguity and candor, apply. Hybrid role; work on-site in the U.S. and travel to in-person events as needed. Candidates must be authorized to work in the U.S. Salary range: $280,000–$350,000/year.
- Provide scientific and strategic leadership for multiple late-stage clinical programs, including anticipated regulatory interactions.
- Lead projects supporting clinical research programs; assist with business development as needed; foster innovation and external collaboration.
Responsibilities
- Supervise one or more direct reports and lead the clinical development team for a product.
- Lead design and execution of projects for clinical research programs.
- Lead clinical study team activities: protocol development, protocol monitoring, study reports, training documents, and other clinical/regulatory documents.
- Facilitate clinical development goals and achievement of study quality metrics.
- Contribute to preparation and execution of investigator and advisory board meetings.
- Work across multiple projects and teams; stay current on regulations/guidelines and scientific advances.
- Build relationships with external partners (clinical investigators, clinicians, scientists).
- Assist with due diligence for business development opportunities.
- May require travel to field sites, meetings, and conferences.
Qualifications
- Doctorate degree (MD/DO preferred); practicing physician experience required.
- 15+ years clinical/research experience, including 5 years industry experience.
- Experience interpreting clinical data (safety/efficacy); knowledge of biostatistics, GCP, and regulatory requirements.
Skills
- Independent, timely decision-making; strong written/verbal communication.
- Collaboration in a fast-paced matrix environment; organizational/project management skills.
Benefits (as stated)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions
- If you’re solution-oriented and comfortable with ambiguity and candor, apply. Hybrid role; work on-site in the U.S. and travel to in-person events as needed. Candidates must be authorized to work in the U.S. Salary range: $280,000–$350,000/year.