Role Summary
Executive Medical Director Oncology Clinical Development - Gynecological Cancers. Manages multiple levels of medical and scientific leadership, directing the planning, execution, and interpretation of clinical trials across several development programs. Serves as the in-house clinical and drug development expert, guiding cross-functional teams and ensuring high-quality clinical data to support product strategy. Acts as a mentor to individuals and teams to drive excellence in assigned tasks.
Responsibilities
- Accountable for leaders who design and implement multiple clinical development programs, ensuring adherence to medical principles, regulatory requirements, and business strategy; provide education to investigators, site personnel, and study staff.
- Train and mentor staff on Asset Development Teams (ADTs), ADT Leadership Boards (ALBs), Clinical Strategy Teams (CSTs), and clinical study teams to deliver a high-quality, aligned Clinical Development Plan and study deliverables; monitor study integrity, enrollment, and timelines.
- Provide or ensure clarity for review and approval of design, analysis, interpretation, and reporting of scientific content across protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other documents.
- Manage two levels of Medical and Scientific Directors (2β4 direct; 6+ overall) and/or Clinical Scientists; oversee clinical development activities and staff, including hiring, onboarding, mentoring, training, and career development.
- In rare cases, lead a CST for a highly complex program, supervising matrix team members and representing Clinical Research to ADTs, ALBs, and cross-functional teams.
- Serve as the in-house clinical and drug development expert across multiple molecules/disease areas; contribute to due diligence and translational strategies; collaborate with Discovery on disease-area strategies at a program/platform level.
- Act as a senior liaison for opinion leader interactions; partner with Medical Affairs, Commercial, and other functions to integrate cross-functional perspectives into disease-area strategies and Clinical Development Plans.
- Stay current with medical literature and conferences; represent AbbVie at external meetings to enhance the companyβs industry standing.
- Understand regulatory requirements for clinical studies and global drug development; serve as a senior clinical representative in regulatory discussions; ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs, and other quality standards.
Qualifications
- Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant therapeutic specialty; residency strongly preferred; subspecialty fellowship desirable.
- At least 10 years (12+ preferred) of clinical trial experience in pharmaceutical industry or academia with deep therapeutic area expertise.
- Ability to prioritize and lead multiple complex clinical programs; strong cross-functional leadership and influence.
- Proven leadership and people development experience; able to manage through influence in a global matrix environment.
- Experience as a direct or matrixed manager with track record of training and autonomous staff development.
- Ability to interact with external and internal stakeholders to support global scientific and business strategies.
- Extensive knowledge of clinical trial methodology, regulatory/compliance requirements, and experience in clinical strategy development and protocol design.
- Excellent oral and written English communication skills.
- Ability to exercise judgment and solve complex problems across multiple projects.
Skills
- Clinical development leadership
- Strategy development and execution
- Regulatory compliance and Good Clinical Practices
- Cross-functional collaboration
- Mentoring and staff development
- Due diligence and translational planning
- Stakeholder engagement and external representation
Education
- Doctoral degree as above (M.D./D.O. or equivalent); residency completed; subspecialty fellowship desirable.