Senior Director, Clinical Development
Sarepta Therapeutics
5 hours ago
Remote friendly (Chicago, IL)
United States
$280,000 - $350,000 USD yearly
Clinical Research and Development
The Importance of the Role
Reporting to the Head of Clinical Development, lead scientific and strategic leadership for multiple late-stage clinical programs, including anticipated regulatory interactions. Lead projects under the Head of Clinical Development; assist as needed to support business development; foster innovation and external collaboration.
Responsibilities
- Supervises one or more direct reports and leads the clinical development team for a product
- Leads the design and execution of projects supporting clinical research programs
- Leads the clinical study team in protocol development, protocol monitoring, study reports, training documents, and other clinical/regulatory documents
- Leads the clinical development product team to facilitate clinical development goals and achieve study quality metrics
- Contributes to the organization, preparation, and execution of investigator and advisory board meetings
- Works effectively across multiple projects and teams
- Stays current on regulations/guidelines and scientific advances in the therapeutic area
- Cultivates relationships with external partners (clinical investigators, clinicians, scientists)
- Assists 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
- Experience analyzing and interpreting clinical data (safety/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 matrix environment
- Excellent written and verbal communication skills
- Intellectual curiosity, flexibility, persistence
- Strong organizational and project management skills
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators
Work Setup / Instructions
- Hybrid role: work on site at a Sarepta facility in the U.S. and/or attend in-person, company-sponsored events as needed.
- Candidates must be authorized to work in the U.S.
Reporting to the Head of Clinical Development, lead scientific and strategic leadership for multiple late-stage clinical programs, including anticipated regulatory interactions. Lead projects under the Head of Clinical Development; assist as needed to support business development; foster innovation and external collaboration.
Responsibilities
- Supervises one or more direct reports and leads the clinical development team for a product
- Leads the design and execution of projects supporting clinical research programs
- Leads the clinical study team in protocol development, protocol monitoring, study reports, training documents, and other clinical/regulatory documents
- Leads the clinical development product team to facilitate clinical development goals and achieve study quality metrics
- Contributes to the organization, preparation, and execution of investigator and advisory board meetings
- Works effectively across multiple projects and teams
- Stays current on regulations/guidelines and scientific advances in the therapeutic area
- Cultivates relationships with external partners (clinical investigators, clinicians, scientists)
- Assists 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
- Experience analyzing and interpreting clinical data (safety/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 matrix environment
- Excellent written and verbal communication skills
- Intellectual curiosity, flexibility, persistence
- Strong organizational and project management skills
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators
Work Setup / Instructions
- Hybrid role: work on site at a Sarepta facility in the U.S. and/or attend in-person, company-sponsored events as needed.
- Candidates must be authorized to work in the U.S.