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:
- With appropriate supervision, manages the design and implementation of study protocols for a clinical development program; oversees project-related education of investigators, study site personnel and AbbVie study staff.
- Reviews, interprets, and communicates accumulating safety and efficacy data; may oversee study enrollment and overall timelines for key deliverables.
- Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and 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 other functions as required.
- Stays abreast of professional information and technology via conferences, medical literature, and training.
- Understands regulatory requirements related to clinical studies and global drug development; may contribute to regulatory responses and discussions.
- 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 and direction to clinical research with appropriate supervision.
- Strong desire to collaborate in a cross-functional setting.
- Clinical trial experience in pharmaceutical industry, academia, or equivalent preferred.
- Knowledge of clinical trial methodology, regulatory/compliance requirements; experience designing study protocols desirable.
- Ability to interact externally and internally to support global scientific and business strategy.
- Excellent oral and written English communication skills.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.