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 in support of the Product Development Plan; 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 (with Clinical Operations).
- Contributes to design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May contribute to a rigorous, cross-functionally-aligned Clinical Development Plan with matrix team members.
- Participates in opinion leader interactions related to the disease area(s) with Medical Affairs, Commercial, and other functions as required.
- Stays abreast of professional information and technology to augment therapeutic area expertise.
- Understands regulatory requirements for clinical studies and global drug development; may contribute to regulatory responses/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 pharma 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.