Senior Director, Clinical Development
Sarepta Therapeutics
5 hours ago
Remote friendly (San Francisco, CA)
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 direction of 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 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 up to date on 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 the due diligence process for business development opportunities.
- May require travel to field sites, internal/external meetings, and conferences.
More About You (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/interpreting clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Ability to make independent, timely, and appropriate decisions.
- Collaborative, fast-paced matrix environment experience.
- 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 applicable)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions
- Apply for the position.
- 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 direction of 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 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 up to date on 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 the due diligence process for business development opportunities.
- May require travel to field sites, internal/external meetings, and conferences.
More About You (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/interpreting clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
- Ability to make independent, timely, and appropriate decisions.
- Collaborative, fast-paced matrix environment experience.
- 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 applicable)
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application Instructions
- Apply for the position.