Manages other Medical and/or Scientific Directors and leads the direction, planning, execution, 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:
- Lead and demonstrate ownership of the design and implementation of multiple clinical development programs (or one large, complex program); oversee project-related education for investigators and study sites.
- Lead and mentor clinical study teams; monitor study integrity; review/interpret/communicate safety and efficacy data. With Clinical Operations, ensure enrollment and timelines; assess and report serious adverse events per policy and regulations.
- Own the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, clinical study reports, regulatory submissions/responses, and other program documents.
- Manage 2β4 Medical/Scientific Directors and/or Clinical Scientists; oversee hiring, onboarding, mentoring, training, and career development.
- May chair Clinical Strategy Team(s) and develop a cross-functionally aligned Clinical Development Plan; supervise matrix teams and serve as Clinical Research representative to Asset Development Teams.
- Serve as in-house clinical expert for molecules/diseases; coordinate scientific activities; may contribute to due diligence/business development; contribute to translational strategies.
- Act as clinical lead and solicit opinion leader interactions; partner with Medical Affairs/Commercial to incorporate cross-functional perspectives.
- Stay current via conferences/literature/training; may represent AbbVie externally.
- Understand and comply with regulatory requirements; serve as clinical representative in key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D./D.O. or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; fellowship desirable.
- 7+ years (9+ preferred) clinical trial experience in pharma/academia.
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead/manage through influence on a cross-functional global team.
- Commitment to training/development of junior staff; appropriate autonomy.
- Ability 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.
- Ability to exercise judgment and solve complex problems across multiple projects.