Job Description
Leads the direction, planning, and interpretation of clinical trials or research activities for one or more clinical development programs; may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting product scientific and business strategy.
Responsibilities:
- Own design and implementation of multiple (or one large complex) clinical development programs; oversee education of investigators, study site personnel, and AbbVie study staff.
- Lead clinical study teams; ensure study integrity; review/interpret/communicate accumulating safety and efficacy data; ensure agreed enrollment and key deliverable timelines with Clinical Operations.
- 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 co-chair Integrated Evidence Strategy Team(s) and develop cross-functionally aligned Clinical Development Plans; may supervise matrix team members and serve as clinical research representative to Asset Development Teams/boards.
- Serve as in-house clinical expert for molecules/diseases; coordinate scientific/medical activities with internal stakeholders; may contribute to due diligence and translational strategies.
- Act as clinical lead for opinion leader interactions with Medical Affairs, Commercial, and others.
- Stay current via conferences/literature; may represent the company externally.
- Understand and comply with regulatory requirements; serve as clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance, SOPs, and quality standards.
Qualifications:
- BS in sciences; MS/PhD preferred.
- 8+ years clinical trial experience in pharma/academia/equivalent.
- Ability to run complex clinical research independently.
- Proven leadership; lead through influence on cross-functional global teams.
- Excellent oral/written English communication.
- Extensive knowledge of clinical trial methodology, regulatory/compliance; experience developing clinical strategy and study protocols.
- Ability to interact internally/externally for global scientific/business strategy; strong judgment and problem-solving.
Benefits (if eligible):
- Paid time off, medical/dental/vision insurance, 401(k).
- Eligible for long-term incentive programs.