Job Description
Leads the direction, planning, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver and disseminate high-quality clinical data supporting overall product scientific and business strategy.
Responsibilities:
- Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the product development plan; oversees project-related education of investigators, study site personnel, and AbbVie study staff.
- May lead clinical study teams; monitors study integrity and reviews/interprets/communicates accumulating safety and efficacy data. With Clinical Operations, ensures study enrollment and timelines for key deliverables.
- Owns design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists.
- May serve on or co-chair Integrated Evidence Strategy Team(s) to develop a rigorous Clinical Development Plan; as CST Co Chair, may supervise matrix team members and serve as Clinical Research representative to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs).
- Serves as in-house clinical expert for one or more molecules/diseases; coordinates scientific/medical activities with internal stakeholders; may contribute to due diligence/business development and translational strategies.
- Acts as clinical lead for opinion leader interactions; partners with Medical Affairs, Commercial, and other functions.
- Stays current via conferences/literature/training; may represent AbbVie at external meetings.
- Understands and ensures compliance with regulatory requirements; serves as clinical representative for regulatory discussions.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- Bachelorβs degree in the sciences; advanced degree (MS, PhD) preferred.
- At least 8 years of clinical trial experience (pharmaceutical industry, academia, or equivalent).
- Ability to run a complex clinical research program independently.
- Proven leadership skills; ability to lead through influence on cross-functional global teams.
- Ability to interact externally and internally to support global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements; experience developing clinical strategy and study protocols.
- Excellent oral and written English communication skills.
- Ability to exercise judgment and solve complex problems for one or more projects.