Senior Director, Clinical Development
Sarepta Therapeutics
6 hours ago
Remote friendly (Minneapolis, MN)
United States
$280,000 - $350,000 USD yearly
Clinical Research and Development
The Importance of the Role
- Reporting to the Head of Clinical Development, provide 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 / Opportunity to Make a Difference
- Supervise one or more direct reports and lead the clinical development team for a product.
- Lead design and execution of projects supporting clinical research programs.
- Lead clinical study team activities including protocol development, protocol monitoring, study reports, training documents, and other clinical/regulatory documents.
- Lead clinical development product team work to facilitate development goals and achieve study quality metrics.
- Contribute to preparation and execution of investigator and advisory board meetings with project teams and stakeholders.
- Work effectively across multiple projects and teams.
- Maintain up-to-date knowledge of regulations, guidelines, and scientific advances for the therapeutic area.
- Cultivate relationships with external partners (clinical investigators, clinicians, scientists) to support innovation and business development.
- Assist with due diligence for business development opportunities.
- May require travel to field sites, internal/external meetings, and conferences.
Qualifications / More About You
- Doctorate degree: MD or DO preferred.
- Experience as a practicing physician required.
- At least 15 years clinical/research experience, including 5 years industry experience.
- Experience analyzing and interpreting clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements.
- Ability to make independent, timely, appropriate decisions.
- Ability to work collaboratively in a fast-paced, matrix environment.
- Excellent written and verbal communication skills.
- Intellectual curiosity, flexibility, persistence.
- High organizational and project management skills.
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
Benefits / Application instructions / Work arrangement
- Hybrid: expected to work on-site at a U.S. facility and/or attend company-sponsored in-person events from time to time.
- Targeted salary range: $280,000 - $350,000 per year.
- Candidates must be authorized to work in the U.S.
- Reporting to the Head of Clinical Development, provide 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 / Opportunity to Make a Difference
- Supervise one or more direct reports and lead the clinical development team for a product.
- Lead design and execution of projects supporting clinical research programs.
- Lead clinical study team activities including protocol development, protocol monitoring, study reports, training documents, and other clinical/regulatory documents.
- Lead clinical development product team work to facilitate development goals and achieve study quality metrics.
- Contribute to preparation and execution of investigator and advisory board meetings with project teams and stakeholders.
- Work effectively across multiple projects and teams.
- Maintain up-to-date knowledge of regulations, guidelines, and scientific advances for the therapeutic area.
- Cultivate relationships with external partners (clinical investigators, clinicians, scientists) to support innovation and business development.
- Assist with due diligence for business development opportunities.
- May require travel to field sites, internal/external meetings, and conferences.
Qualifications / More About You
- Doctorate degree: MD or DO preferred.
- Experience as a practicing physician required.
- At least 15 years clinical/research experience, including 5 years industry experience.
- Experience analyzing and interpreting clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements.
- Ability to make independent, timely, appropriate decisions.
- Ability to work collaboratively in a fast-paced, matrix environment.
- Excellent written and verbal communication skills.
- Intellectual curiosity, flexibility, persistence.
- High organizational and project management skills.
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
Benefits / Application instructions / Work arrangement
- Hybrid: expected to work on-site at a U.S. facility and/or attend company-sponsored in-person events from time to time.
- Targeted salary range: $280,000 - $350,000 per year.
- Candidates must be authorized to work in the U.S.