Executive Medical Director, Oncology Early Development
About The Position
Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting product scientific and business strategy. The role leads the design and implementation of multiple clinical development programs, or one large and complex program, in support of the product development plan. It oversees investigator and study-staff education, leads clinical study teams, monitors study integrity, and reviews, interprets, and communicates accumulating safety and efficacy data. In partnership with Clinical Operations, the role supports study enrollment and key deliverable timelines and is responsible for assessment and reporting of serious adverse events on assigned protocols. The position owns the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents. It may oversee Medical or Scientific Directors and may serve on or chair Clinical Strategy Teams, developing rigorous, cross-functionally aligned Clinical Development Plans and contributing clinical expertise to Asset Development Teams and their leadership boards. The Executive Medical Director serves as an in-house clinical expert for molecules and diseases in the therapeutic area, leads scientific and medical activities with internal stakeholders, and may contribute to business development diligence and translational strategies. The role leads clinical interactions with opinion leaders and collaborates with Medical Affairs, Commercial, and other functions. It maintains therapeutic expertise, may represent AbbVie at external meetings, serves as a clinical representative in regulatory discussions, and ensures compliance with regulatory requirements, Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Requirements
- M.D., D.O., or non-U.S. equivalent M.D. degree with a relevant therapeutic specialty in an academic or hospital environment.
- At least 5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
- Ability to independently run a complex clinical research program.
- Proven leadership skills and ability to bring out the best in others on a cross-functional global team; must be able to lead through influence.
- Ability to interact internally and externally to support a global scientific and business strategy.
- Extensive knowledge of clinical trial methodology and regulatory and compliance requirements governing clinical trials.
- Experience developing clinical strategy and designing study protocols.
- Excellent oral and written English communication skills.
- Ability to exercise judgment, address complex problems, and create solutions for one or more projects.
Nice To Haves
- Completion of a residency program is strongly preferred.
- Completion of a subspecialty fellowship is desirable.
- Seven years of clinical trial experience is preferred.
- Experience with immune-redirecting therapies such as T-cell engagers is desirable.
Responsibilities
- Lead and own the design and implementation of multiple clinical development programs or one large, complex program in support of the product development plan.
- Oversee project-related education for investigators, study-site personnel, and AbbVie study staff.
- Lead clinical study teams and monitor overall study integrity.
- Review, interpret, and communicate accumulating safety and efficacy data.
- Partner with Clinical Operations to support agreed-upon enrollment and timelines for key study deliverables.
- Assess and report serious adverse events for assigned protocols in accordance with corporate policy and regulations.
- Own the design, analysis, interpretation, and reporting of scientific content in protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
- May oversee Medical and/or Scientific Directors working on the same or related programs.
- May serve on or chair Clinical Strategy Teams and develop a rigorous, cross-functionally aligned Clinical Development Plan, considering contingencies and alternative approaches.
- As Clinical Strategy Team Chair, may supervise matrix team members and represent Clinical Research on Asset Development Teams and Asset Development Team Leadership Boards.
- Serve as an in-house clinical expert for molecules and diseases in the therapeutic area and coordinate or lead related scientific and medical activities with internal stakeholders.
- May contribute clinical development expertise to due diligence or other business development activities.
- As program needs require, partner with Discovery colleagues to design and implement translational strategies.
- Lead clinical activities and opinion-leader interactions related to the disease area, partnering with Medical Affairs, Commercial, and other functions as required and consistent with corporate policies.
- Maintain expertise through conferences, medical literature, and other training; may represent AbbVie at external meetings.
- Understand and comply with regulatory requirements for clinical studies and global drug development, and serve as a clinical representative in key regulatory discussions.
- Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligible to participate in long-term incentive programs.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
