Purpose:
Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Supports cross-functional teams to generate and disseminate high-quality clinical data.
Responsibilities:
- Own design and implementation of multiple (or one large complex) clinical development programs; oversee investigator/site/AbbVie study staff education.
- Lead clinical study teams; monitor study integrity; review/interpret/communicate safety and efficacy data. Ensure enrollment and timelines with Clinical Operations; assess/report serious adverse events per policy and regulations.
- Own scientific content design, analysis, interpretation, and reporting for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions/responses, and other program documents.
- May oversee Medical/Scientific Directors and Clinical Scientists.
- May chair Clinical Strategy Teams to develop a vetted Clinical Development Plan; supervise matrix team members and serve as Clinical Research representative to Asset Development Teams.
- Serve as in-house clinical expert for molecules/diseases; coordinate scientific/medical activities; contribute to due diligence and translational strategies.
- Act as clinical lead; solicit opinion leader interactions; partner with Medical Affairs/Commercial and others.
- Stay current via literature and training; may represent the company externally.
- Ensure regulatory compliance; serve as clinical representative for key regulatory discussions.
- Ensure GCP, pharmacovigilance, SOP, and other quality standards.
Qualifications:
- MD/DO (or non-US equivalent) with relevant specialty; residency strongly preferred; oncology fellowship desirable.
- 5+ years (7+ preferred) clinical trial experience.
- Ability to run complex program independently; proven cross-functional leadership and ability to lead through influence.
- Extensive knowledge of clinical trial methodology and regulatory/compliance requirements; clinical strategy/protocol design experience.
- Excellent oral/written English communication; sound judgment for complex problems.
Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees; eligible for long-term incentive programs.