Purpose:
Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs, and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data.
Responsibilities:
- Leads and owns design and implementation of multiple clinical development programs (or one large, complex program), including investigator/site and internal staff education.
- Leads clinical study teams, ensures study integrity, reviews/interprets/communicates safety and efficacy data; partners with Clinical Operations on enrollment and key deliverable timelines; assesses and reports serious adverse events per policy.
- Owns scientific content design, analysis, interpretation, and reporting for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists.
- May serve as Clinical Strategy Team(s) member or chair; develops cross-functionally aligned Clinical Development Plan with contingencies; may supervise matrix teams and represent Clinical Research on ADTs/ALBs.
- Acts as in-house clinical expert for molecules/diseases; coordinates scientific/medical activities; may support due diligence/business development and translational strategy with Discovery.
- Acts as clinical lead; solicits opinion leader interactions; partners with Medical Affairs/Commercial and other functions to incorporate perspectives into plans/protocols.
- Stays current via conferences/literature/training; may represent the company externally.
- Ensures compliance with regulatory requirements; serves as clinical representative for regulatory discussions/responses.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D./D.O. (or non-US equivalent) with relevant therapeutic specialty; residency strongly preferred; oncology fellowship desirable.
- 5+ years (7 preferred) clinical development/trial experience.
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead through influence on cross-functional global teams.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, clinical strategy development, and protocol design.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for long-term incentive programs.
Application instructions:
- None provided in the text.