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 supporting product scientific and business strategy.
Responsibilities:
- Manages design and implementation of one or more clinical development programs; oversees project-related education for investigators, study site personnel, and AbbVie study staff.
- Oversees clinical studiesβ integrity; reviews/interprets/communicates accumulating safety and efficacy data. Oversees enrollment and timelines for key deliverables; assesses/reports serious adverse events per policy and regulations.
- Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May oversee Medical Directors/Scientific Directors and Clinical Scientists.
- Provides in-house clinical expertise; coordinates scientific/medical activities with internal stakeholders; may support due diligence/business development and translational strategy with Discovery.
- May chair a Clinical Strategy Team (CST) to develop a vetted, cross-functionally aligned Clinical Development Plan; may supervise matrix team members and serve as Clinical Research representative to an Asset Development Team (ADT).
- Solicits opinion leader interactions; partners with Medical Affairs, Commercial, and other functions to incorporate cross-functional perspectives into plans/protocols.
- Stays current via conferences, medical literature, and training.
- Understands and complies 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; subspecialty fellowship desirable.
- At least 2 years clinical trial experience (pharma, academia, or equivalent).
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to lead on cross-functional global teams and interact internally/externally.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience in clinical strategy and study protocol design.
- Excellent oral and written English communication skills.