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 in support of the Product Development Plan; oversees project-related education of investigators, study site personnel, and AbbVie study 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 of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May oversee Medical Directors/Scientific Directors and Clinical Scientists on related programs.
- Provides in-house clinical expertise; coordinates scientific/medical activities with internal stakeholders; may support due diligence/business development; contributes to translational strategy with Discovery.
- May 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 Asset Development Teams).
- 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.
- Ensures regulatory understanding and compliance; 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 in an academic/hospital setting; residency strongly preferred; fellowship desirable.
- At least 2 years of clinical trial experience in pharma/academia/equivalent.
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to succeed 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 in clinical strategy development and protocol design.
- Excellent oral and written English communication skills.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for long-term incentive programs.