Senior Director, Clinical Development
Sarepta Therapeutics
5 hours ago
Remote friendly (Hartford, CT)
United States
$280,000 - $350,000 USD yearly
Clinical Research and Development
The Importance of the Role:
- Report to the Head of Clinical Development and provide scientific and strategic leadership for multiple late-stage clinical programs, including anticipated regulatory interactions.
- Lead projects under the Head of Clinical Development; 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 the design and execution of projects supporting clinical research programs.
- Lead protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents.
- Lead the clinical development product team to facilitate clinical development goals and achieve study quality metrics.
- Contribute to organizing, preparing, and executing investigator and advisory board meetings.
- Work effectively across multiple projects and teams.
- Stay current on regulations, guidelines, and scientific advances relevant to the therapeutic area.
- Cultivate relationships with external partners (clinical investigators, clinicians, scientists) in support of innovation and business development.
- Assist with due diligence for business development opportunities.
- May require travel to field sites, internal/external 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 and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
Skills:
- Independent, timely, and appropriate decision-making.
- Collaborative approach 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:
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application instructions:
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and value kindness and integrity.
- Report to the Head of Clinical Development and provide scientific and strategic leadership for multiple late-stage clinical programs, including anticipated regulatory interactions.
- Lead projects under the Head of Clinical Development; 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 the design and execution of projects supporting clinical research programs.
- Lead protocol development, protocol monitoring, study reports, training documents, and other clinical and regulatory documents.
- Lead the clinical development product team to facilitate clinical development goals and achieve study quality metrics.
- Contribute to organizing, preparing, and executing investigator and advisory board meetings.
- Work effectively across multiple projects and teams.
- Stay current on regulations, guidelines, and scientific advances relevant to the therapeutic area.
- Cultivate relationships with external partners (clinical investigators, clinicians, scientists) in support of innovation and business development.
- Assist with due diligence for business development opportunities.
- May require travel to field sites, internal/external 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 and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
Skills:
- Independent, timely, and appropriate decision-making.
- Collaborative approach 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:
- Physical and Emotional Wellness; Financial Wellness; Support for Caregivers.
Application instructions:
- Apply if you are solution-oriented, comfortable with ambiguity and candor, and value kindness and integrity.