Head of Asset in GU, Oncology Clinical Development
AbbVie
July 03, 2026
Remote friendly (Waltham, MA)
United States
$248,000 - $471,500 USD yearly
Clinical Research and Development
Responsibilities:
- Lead the direction, planning, execution, and interpretation of clinical trials/research activities for one or more clinical development programs.
- Own design and implementation of multiple clinical development programs (or one large, complex program), ensuring compliance with medical/scientific principles, regulatory requirements, and emerging issues; oversee education of investigators and site personnel.
- Lead and mentor clinical study teams; ensure study integrity; review/interpret/communicate accumulating safety and efficacy data.
- With Clinical Operations, ensure agreed enrollment and timelines for key deliverables; assess and report serious adverse events per policy and regulations.
- Own design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, clinical study reports, regulatory submissions/responses, and other program documents.
- Manage and develop Medical/Scientific Directors (typically 2–4) and/or Clinical Scientists (hiring, onboarding, mentoring, training, career development).
- May chair Clinical Strategy Team(s) to develop a vetted, cross-functionally aligned Clinical Development Plan; supervise matrix team members and serve as Clinical Research representative to ADTs/ALBs.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate translational strategies with Discovery as needed.
- Act as clinical lead for 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.
- Ensure understanding and compliance 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. (or non-US equivalent) with relevant therapeutic specialty; residency strongly preferred; fellowship desirable.
- 7+ years (9+ preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead/manage through influence on cross-functional global teams.
- Commitment to training and development of junior staff.
- Ability to interact externally/internally to support global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication skills.
- Ability to exercise judgment, address complex problems, and create solutions across multiple projects.
- Lead the direction, planning, execution, and interpretation of clinical trials/research activities for one or more clinical development programs.
- Own design and implementation of multiple clinical development programs (or one large, complex program), ensuring compliance with medical/scientific principles, regulatory requirements, and emerging issues; oversee education of investigators and site personnel.
- Lead and mentor clinical study teams; ensure study integrity; review/interpret/communicate accumulating safety and efficacy data.
- With Clinical Operations, ensure agreed enrollment and timelines for key deliverables; assess and report serious adverse events per policy and regulations.
- Own design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, clinical study reports, regulatory submissions/responses, and other program documents.
- Manage and develop Medical/Scientific Directors (typically 2–4) and/or Clinical Scientists (hiring, onboarding, mentoring, training, career development).
- May chair Clinical Strategy Team(s) to develop a vetted, cross-functionally aligned Clinical Development Plan; supervise matrix team members and serve as Clinical Research representative to ADTs/ALBs.
- Serve as in-house clinical expert for one or more molecules/diseases; coordinate translational strategies with Discovery as needed.
- Act as clinical lead for 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.
- Ensure understanding and compliance 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. (or non-US equivalent) with relevant therapeutic specialty; residency strongly preferred; fellowship desirable.
- 7+ years (9+ preferred) clinical trial experience in pharma/academia/equivalent.
- Ability to run a complex clinical research program independently.
- Proven leadership; ability to lead/manage through influence on cross-functional global teams.
- Commitment to training and development of junior staff.
- Ability to interact externally/internally to support global scientific and business strategy.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and clinical strategy/protocol design.
- Excellent oral and written English communication skills.
- Ability to exercise judgment, address complex problems, and create solutions across multiple projects.