Purpose:
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs; generates, delivers, and interprets high-quality clinical data to support product scientific and business strategy.
Responsibilities:
- Manages design and implementation of one or more clinical development programs within the Product Development Plan; ensures compliance with medical/scientific principles and regulatory requirements; oversees project-related education for investigators, sites, and AbbVie staff.
- Oversees clinical studies and study integrity; reviews, interprets, and communicates accumulating safety/efficacy data; with Clinical Operations, oversees enrollment and timelines for key deliverables; assesses and reports serious adverse events per policy and regulations.
- Designs, analyzes, interprets, and reports scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other documents.
- May oversee Medical/Scientific Directors and Clinical Scientists on related programs.
- Provides in-house clinical expertise for the molecule/disease; coordinates scientific/medical activities; may participate in due diligence/business development; contributes to translational strategies with Discovery.
- May serve on or chair a Clinical Strategy Team to develop a cross-functionally aligned Clinical Development Plan; may supervise matrix team members and serve as Clinical Research representative to an Asset Development Team.
- Acts as a clinical interface; solicits opinion leader interactions and partners with Medical Affairs/Commercial and others.
- Stays current via conferences, literature, and training.
- Ensures compliance with regulatory requirements; serves as clinical representative for key regulatory discussions.
- 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; fellowship desirable.
- At least 2 years of clinical trial experience in pharma, academia, or equivalent.
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to lead on cross-functional global teams; interact externally/internally for global scientific/business strategy.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.
Benefits (if explicitly part of the job description):
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); eligible for long-term incentive programs.