Purpose:
Oversees direction, planning, execution, and interpretation of clinical trials/research for one or more clinical development programs; delivers high-quality clinical data to support product scientific and business strategy.
Responsibilities:
- Manages design and implementation of clinical development programs aligned to the Product Development Plan; oversees project-related education for investigators, sites, and AbbVie staff.
- Oversees clinical studiesβ integrity; reviews, interprets, and communicates accumulating safety/efficacy data; with Clinical Operations, oversees enrollment and key deliverable timelines; assesses and reports serious adverse events per policy/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/Scientific Directors and Clinical Scientists.
- Provides in-house clinical expertise; coordinates internal scientific/medical activities; 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 members and represent clinical research to Asset Development Teams.
- Solicits opinion leader input; partners with Medical Affairs/Commercial and others to incorporate perspectives into plans/protocols.
- Stays current via conferences/literature/training.
- Understands and complies with regulatory requirements; serves as clinical representative in key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance, SOPs, and quality standards.
Qualifications:
- MD/DO or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; fellowship desirable.
- 2+ years clinical trial experience in pharma/academia/equivalent.
- Ability to run moderate-complexity clinical research with minimal supervision.
- Cross-functional global teamwork; external/internal interaction to support global strategy.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience designing clinical strategy and study protocols.
- Excellent oral and written English.