Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Leads and owns the design and implementation of multiple clinical development programs (or one large, complex program); oversees project-related education of investigators, study site personnel, and AbbVie study staff.
- Leads clinical study teams; monitors study integrity; reviews, interprets, and communicates accumulating safety and efficacy data; ensures agreed-upon enrollment and key deliverable timelines with Clinical Operations; assesses and reports serious adverse events per policy/regulations.
- Owns design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists on related programs.
- May serve on or chair Clinical Strategy Teams to develop a cross-functionally aligned Clinical Development Plan; may supervise matrix team members and serve as Clinical Research representative to Asset Development Teams/Leadership Boards.
- Serves as in-house clinical expert for one or more molecules/diseases; coordinates scientific/medical activities with internal stakeholders; may contribute to due diligence/business development and translational strategy with Discovery.
- Acts as clinical lead for opinion leader interactions with Medical Affairs, Commercial, and other functions per policy.
- Stays current via conferences/literature/training; may represent AbbVie externally.
- Ensures understanding/compliance with regulatory requirements; serves as clinical representative for regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance, SOPs, and quality standards.
Qualifications:
- M.D./D.O./non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- 5+ years (7 preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run complex clinical research programs independently.
- Proven leadership; lead through influence on cross-functional global teams.
- Extensive knowledge of clinical trial methodology and regulatory/compliance requirements; experience developing clinical strategy and designing study protocols.
- Excellent oral/written English communication skills.
- Ability to exercise judgment, address complex problems, and create solutions.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
Application instructions:
- No direct application instructions provided in the job description.