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; 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 and regulatory documents.
- Lead the clinical development product team to facilitate goals and achieve study quality metrics.
- Contribute to organizing, preparing, and executing investigator and advisory board meetings with project teams and stakeholders.
- Work effectively across multiple projects and teams.
- Stay current on regulations, guidelines, and therapeutic area/s scientific advances (internal and external).
- 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 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.
- 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, persistence.
- High level of organizational and project management skills.
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
Benefits (explicitly mentioned)
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
Application / Work Setup
- Hybrid role: work on site at a U.S. facility and/or attend company-sponsored in-person events from time to time.
- Candidates must be authorized to work in the U.S.
- Apply if you are solution-oriented and comfortable with ambiguity and candor.