Job Description
Leads the direction, planning, execution, and interpretation of clinical trials/research activities for one or more clinical development programs. May lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data.
Responsibilities
- Own design and implementation of multiple clinical development programs (or one complex program); oversee education for investigators, study sites, and AbbVie staff.
- Lead clinical study teams; monitor study integrity; review/interpret/communicate safety and efficacy data; ensure study enrollment and key deliverable timelines with Clinical Operations; assess/report serious adverse events.
- Own 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 chair Clinical Strategy Teams; develop rigorous cross-functionally aligned Clinical Development Plans; supervise matrix members; serve as Clinical Research representative to Asset Development Teams/boards.
- Serve as in-house clinical expert; coordinate translational strategies with Discovery.
- Act as clinical lead for opinion leader interactions in coordination with Medical Affairs/Commercial.
- Stay current via conferences/literature/training; may represent company externally.
- Ensure compliance with regulatory requirements; serve as clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications
- M.D./D.O./non-US equivalent with relevant specialty; residency strongly preferred; fellowship desirable.
- At least 5 years (7 preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run complex clinical research independently.
- Proven leadership; lead through influence on cross-functional global teams.
- Strong knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English.
- Judgment to address complex problems.
Benefits (if eligible)
- Paid time off; medical/dental/vision insurance; 401(k). Eligible for long-term incentive programs.