Responsibilities:
- With supervision, oversees the direction, planning, execution, and interpretation of clinical trials/research activities for a clinical development program; participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data.
- Manages design and implementation of study protocols aligned to the Product Development Plan; applies medical/scientific principles and knowledge of compliance/regulatory requirements.
- Oversees project education of investigators, study site personnel, and AbbVie study staff.
- Ensures oversight of clinical studies, study integrity, and review/interpretation/communication of accumulating safety and efficacy data; oversees enrollment and key deliverable timelines with Clinical Operations.
- Assesses and reports serious adverse events per policy/regulations; contributes to scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other program documents.
- May serve as clinical representative on Clinical Strategy Team; contributes to Clinical Development Plan development.
- Participates in opinion leader interactions with Medical Affairs/Commercial and others as required.
- Stays current via conferences/literature/training.
- Ensures understanding and compliance with regulatory requirements; may contribute to regulatory responses.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- Medical Doctor (M.D.) / Doctor of Osteopathy (D.O.) or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- Ability to run clinical research study with appropriate supervision.
- Strong cross-functional collaboration interest.
- Clinical trial experience preferred.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; protocol design experience desirable.
- Ability to interact internally/externally to support global scientific/business strategy.
- Excellent oral and written English communication skills.