Executive Medical Director, Oncology Early Development
AbbVie
13 hours ago
Remote friendly (San Francisco, CA)
United States
$206,500 - $393,000 USD yearly
Clinical Research and Development
Purpose:
Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs, with principal responsibility for clinical strategy and end-to-end Clinical Development Plan(s). Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data.
Responsibilities:
- Lead and own design and implementation of multiple clinical development programs (or one large, complex program) supporting overall product development plan; oversee education of investigators, study site personnel, and AbbVie staff.
- Lead clinical study teams, monitor study integrity, and review/interpret/communicate accumulating 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 serve on or chair Clinical Strategy Teams to develop cross-functionally aligned Clinical Development Plans across Ph1–Ph3; as CST Chair may supervise matrix team members and represent Clinical Research to Asset Development Teams.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific/medical activities with stakeholders; may contribute to due diligence/business development and translational strategies.
- Act as clinical lead and solicit opinion leader interactions; partner with Medical Affairs/Commercial/others per policy.
- Stay current via conferences/literature/training; may represent company externally.
- Understand and ensure compliance with regulatory requirements; serve as clinical representative for regulatory discussions.
- Ensure adherence to GCP, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D./D.O. or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- 5+ years (7 preferred) clinical trial experience in pharma/academia.
- Ability to run complex clinical research independently.
- Proven leadership; ability to lead through influence on global cross-functional teams.
- Ability to interact internally/externally to support global strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, clinical strategy development, and study protocol design.
- Excellent oral and written English communication.
- Strong judgment and problem-solving ability.
Benefits:
- Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Application instructions:
- US & Puerto Rico applicants: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- Reasonable accommodation info: https://www.abbvie.com/join-us/reasonable-accommodations.html
Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs, with principal responsibility for clinical strategy and end-to-end Clinical Development Plan(s). Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data.
Responsibilities:
- Lead and own design and implementation of multiple clinical development programs (or one large, complex program) supporting overall product development plan; oversee education of investigators, study site personnel, and AbbVie staff.
- Lead clinical study teams, monitor study integrity, and review/interpret/communicate accumulating 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 serve on or chair Clinical Strategy Teams to develop cross-functionally aligned Clinical Development Plans across Ph1–Ph3; as CST Chair may supervise matrix team members and represent Clinical Research to Asset Development Teams.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific/medical activities with stakeholders; may contribute to due diligence/business development and translational strategies.
- Act as clinical lead and solicit opinion leader interactions; partner with Medical Affairs/Commercial/others per policy.
- Stay current via conferences/literature/training; may represent company externally.
- Understand and ensure compliance with regulatory requirements; serve as clinical representative for regulatory discussions.
- Ensure adherence to GCP, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D./D.O. or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- 5+ years (7 preferred) clinical trial experience in pharma/academia.
- Ability to run complex clinical research independently.
- Proven leadership; ability to lead through influence on global cross-functional teams.
- Ability to interact internally/externally to support global strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, clinical strategy development, and study protocol design.
- Excellent oral and written English communication.
- Strong judgment and problem-solving ability.
Benefits:
- Comprehensive benefits package including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Application instructions:
- US & Puerto Rico applicants: https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
- Reasonable accommodation info: https://www.abbvie.com/join-us/reasonable-accommodations.html