Purpose:
- Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs.
- Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Manages design and implementation of clinical development programs aligned to the Product Development Plan; oversees project-related education of investigators, study site personnel, and AbbVie study staff.
- Oversees clinical studies for integrity; reviews, interprets, and communicates accumulating safety and efficacy data; oversees enrollment and key deliverable timelines with Clinical Operations; 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 program documents.
- May oversee Medical Directors/Scientific Directors and Clinical Scientists.
- Provides in-house clinical expertise for the molecule/disease; coordinates scientific/medical activities; may support due diligence/business development and translational strategy with Discovery.
- May serve on or chair a Clinical Strategy Team (CST) 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 (ADT).
- Acts as clinical interface; solicits opinion leader interactions and partners with Medical Affairs/Commercial to incorporate cross-functional perspectives into plans and protocols.
- Stays current via conferences, medical 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 in academic/hospital environment; residency strongly preferred; subspecialty fellowship desirable.
- At least 2 years of clinical trial experience in pharmaceutical industry/academia (or equivalent).
- Ability to run a moderate-complexity clinical research program with minimal supervision.
- Ability to perform and bring out the best in others on a cross-functional global team.
- Ability to interact externally and internally to support global scientific and business strategy.
- Knowledge of clinical trial methodology and regulatory/compliance requirements; experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.