Purpose:
- With supervision, oversees the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program.
- 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 study protocols (with appropriate supervision) in support of the Product Development Plan; oversees project-related education for investigators, study site personnel, and AbbVie study staff.
- Reviews, interprets, and communicates accumulating safety and efficacy data; with Clinical Operations, may oversee study enrollment and overall timelines for key deliverables.
- Contributes to design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May contribute to development of a cross-functionally aligned Clinical Development Plan.
- Participates in opinion leader interactions; partners with Medical Affairs, Commercial, and others per corporate policies.
- Stays current via conferences, medical literature, and training.
- Understands and complies with regulatory requirements for clinical studies and global drug development; may contribute to regulatory responses.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards.
Qualifications:
- Bachelorβs degree in the sciences; advanced degree (MS, PhD) preferred.
- Ability to provide input/direction to clinical research with appropriate supervision.
- Strong cross-functional collaboration.
- Clinical trial experience in pharmaceutical industry or academia (preferred).
- Knowledge of clinical trial methodology, regulatory/compliance requirements; protocol design experience (desirable).
- Ability to interact externally/internal to support global scientific and business strategy.
- Excellent oral and written English communication skills.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.