Senior Director, Clinical 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.

Role 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 achieve 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 relevant to 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
- Doctorate degree (MD, PhD, or PharmD); 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.

Required/Preferred Skills
- Ability to make independent, timely, and appropriate decisions.
- Ability to collaborate in a fast-paced, matrix environment.
- Excellent written and verbal communication skills.
- Intellectual curiosity, flexibility, and persistence.
- High level of organizational and project management skills.
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.

Benefits (explicitly listed)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers

Application Instructions / Work Location
- Hybrid: expected to work on site at a U.S. facility and attend in-person events from time to time.
- Candidates must be authorized to work in the U.S.