Executive Medical Director, Oncology Early Development
AbbVie
14 hours ago
Remote friendly (North Chicago, IL)
United States
$206,500 - $393,000 USD yearly
Clinical Research and Development
Purpose:
Leads direction, planning, execution, and interpretation of clinical trials/research activities for one or more clinical development programs, with principal responsibility for clinical strategy including end-to-end Clinical Development Plan(s). Participates in and may lead cross-functional teams to deliver high-quality clinical data.
Responsibilities:
- Lead design and implementation of multiple (or one large, complex) clinical development programs; oversee education of investigators, site personnel, and study staff.
- Lead clinical study teams; monitor study integrity; review/interpret/communicate safety and efficacy data. With Clinical Operations, ensure enrollment and timelines for key deliverables. Assess/report serious adverse events per policy and regulations.
- Own design, analysis, interpretation, and reporting of scientific content across protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other documents.
- May oversee Medical/Scientific Directors and Clinical Scientists.
- May chair Clinical Strategy Teams to develop cross-functionally aligned Clinical Development Plans spanning Ph1–Ph3; may supervise matrix team members and serve as Clinical Research representative to Asset Development Teams.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific/medical activities; may support due diligence/BD; contribute translational strategies.
- Act as clinical lead; solicit opinion leader interactions; partner with Medical Affairs/Commercial and others to incorporate cross-functional perspectives into plans/protocols.
- Stay current via conferences/literature/training; may represent company at external meetings.
- Understand and comply with regulatory requirements; serve as clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D./D.O./non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- 5+ years (7 preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run complex clinical research independently.
- Proven cross-functional global leadership; able to lead through influence.
- Ability to interact internally/externally for global scientific/business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication.
- Sound judgment and ability to solve complex problems.
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k) for eligible employees. Eligible for long-term incentive programs.
Application instructions:
- Not provided in the job description text.
Leads direction, planning, execution, and interpretation of clinical trials/research activities for one or more clinical development programs, with principal responsibility for clinical strategy including end-to-end Clinical Development Plan(s). Participates in and may lead cross-functional teams to deliver high-quality clinical data.
Responsibilities:
- Lead design and implementation of multiple (or one large, complex) clinical development programs; oversee education of investigators, site personnel, and study staff.
- Lead clinical study teams; monitor study integrity; review/interpret/communicate safety and efficacy data. With Clinical Operations, ensure enrollment and timelines for key deliverables. Assess/report serious adverse events per policy and regulations.
- Own design, analysis, interpretation, and reporting of scientific content across protocols, Investigator Brochures, Clinical Study reports, regulatory submissions/responses, and other documents.
- May oversee Medical/Scientific Directors and Clinical Scientists.
- May chair Clinical Strategy Teams to develop cross-functionally aligned Clinical Development Plans spanning Ph1–Ph3; may supervise matrix team members and serve as Clinical Research representative to Asset Development Teams.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate scientific/medical activities; may support due diligence/BD; contribute translational strategies.
- Act as clinical lead; solicit opinion leader interactions; partner with Medical Affairs/Commercial and others to incorporate cross-functional perspectives into plans/protocols.
- Stay current via conferences/literature/training; may represent company at external meetings.
- Understand and comply with regulatory requirements; serve as clinical representative for key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and quality standards.
Qualifications:
- M.D./D.O./non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- 5+ years (7 preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run complex clinical research independently.
- Proven cross-functional global leadership; able to lead through influence.
- Ability to interact internally/externally for global scientific/business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication.
- Sound judgment and ability to solve complex problems.
Benefits (as stated):
- Paid time off; medical/dental/vision insurance; 401(k) for eligible employees. Eligible for long-term incentive programs.
Application instructions:
- Not provided in the job description text.