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:
- Manage design and implementation of study protocols for a clinical development program in support of the Product Development Plan; oversee project-related education for investigators, study site personnel, and AbbVie study staff.
- Review, interpret, and communicate accumulating safety and efficacy data; with Clinical Operations, oversee study enrollment and overall timelines for key deliverables.
- Contribute to design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- Contribute to development of a cross-functionally aligned Clinical Development Plan with matrix team members.
- Participate in opinion leader interactions for relevant disease areas with Medical Affairs, Commercial, and other functions as required.
- Stay current on professional information and technology via conferences, medical literature, and training.
- Understand and ensure compliance with regulatory requirements for clinical studies and global drug development; may contribute to regulatory responses/discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards.
Qualifications:
- Bachelorβs degree in the sciences; MS/PhD preferred.
- Ability to provide input and direction to clinical research with appropriate supervision.
- Strong cross-functional collaboration.
- Clinical trial experience in pharma, academia, or equivalent preferred.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; protocol design experience desirable.
- Ability to interact externally and internally to support global scientific and business strategy.
- Excellent oral and written English communication skills.