Purpose:
Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. 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 education of investigators, study site personnel, and AbbVie study staff.
- Oversees clinical study integrity; reviews, interprets, and communicates accumulating safety and efficacy data; with Clinical Operations, oversees enrollment and key deliverable timelines.
- Designs, analyzes, interprets, and reports scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May oversee Associate Scientific Directors and/or Clinical Scientists.
- Provides in-house clinical expertise; coordinates scientific activities with internal stakeholders; may support due diligence/business development; contributes to translational strategies with Discovery.
- May serve on an Integrated Evidence Strategy Team (IEST) to develop a rigorous, cross-functionally-aligned Clinical Development Plan.
- Acts as clinical interface; solicits opinion leader interactions; partners with Medical Affairs, Commercial, and others.
- Stays current via conferences, medical literature, and training.
- Ensures compliance with regulatory requirements; serves as a clinical representative for key regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- Bachelors degree in sciences; MS/PhD/PharmD preferred.
- Input/direction to clinical research with appropriate supervision.
- 5+ years clinical trial experience (pharma industry, academia, or equivalent).
- Can oversee moderate-complexity clinical research with minimal supervision.
- Experience working on cross-functional global teams.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience developing clinical strategy and study protocols.
- Excellent oral and written English communication skills.