Purpose:
Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Generates, delivers, and disseminates high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Leads and demonstrates ownership of design and implementation of multiple (or one large, complex) clinical development programs; oversees project-related education of investigators and study/AbbVie staff.
- Leads clinical study teams; monitors study integrity; reviews/interprets/communicates accumulating safety and efficacy data. Ensures agreed enrollment and key deliverable timelines with Clinical Operations; assesses and reports serious adverse events per policy and regulations.
- Owns design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists.
- May serve on/chair Clinical Strategy Teams; develops a cross-functionally-aligned Clinical Development Plan; may supervise matrix team members and represent Clinical Research to Asset Development Teams.
- Acts as in-house clinical expert for molecules/diseases; coordinates scientific/medical activities; may support due diligence/business development; partners on translational strategies.
- Solicits opinion leader interactions; partners with Medical Affairs, Commercial, and others to incorporate cross-functional perspectives into plans/protocols.
- Stays current via conferences/literature/training; may represent at external meetings.
- Understands and complies with regulatory requirements; represents Clinical Research in key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance, SOPs, and quality standards.
Qualifications:
- M.D., D.O., or 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 a complex clinical research program independently.
- Proven leadership; ability to lead through influence on cross-functional global teams.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience in clinical strategy and protocol design.
- Excellent oral/written English communication.
- Ability to exercise judgment and solve complex problems.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Application instructions:
- None provided in the text.