Purpose:
Oversees the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Generates, delivers, and interprets high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Manages the design and implementation of one or more clinical development programs aligned to the Product Development Plan; oversees project-related education for investigators, study site personnel, and AbbVie staff.
- Oversees clinical 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.
- Provides in-house clinical expertise; coordinates medical/scientific activities with internal stakeholders; may support due diligence/business development and translational strategy with Discovery.
- May chair a Clinical Strategy Team to develop a vetted Clinical Development Plan; in this role may supervise matrix team members and serve as Clinical Research representative to an Asset Development Team.
- Acts as a clinical interface with opinion leader interactions; partners with Medical Affairs/Commercial/others to incorporate perspectives into plans and protocols.
- Stays current via conferences, medical literature, and training.
- Ensures compliance with global regulatory requirements; serves as clinical representative for 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; subspecialty 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 collaborate on a cross-functional global team.
- Ability to interact internally/externally to support global scientific and business strategy.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience designing study protocols and clinical strategy.
- Excellent oral and written English communication.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.