Executive Medical Director, Oncology Early Development

AbbVie•North Chicago, IL

About The Position

Leads the direction, planning, execution, and interpretation of clinical trials or research activities for one or more oncology clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data that supports product scientific and business strategy. Acts as an in-house clinical expert for relevant molecules and diseases, providing medical and scientific expertise across internal teams and key regulatory discussions. Ensures clinical research is conducted in accordance 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 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.
Ability to lead through influence.
Ability to interact internally and externally in support of 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.
Completion of a subspecialty fellowship.
At least 7 years of clinical trial experience.
Experience with immune redirecting therapies, such as T-cell engagers.

Responsibilities

Lead and own the design and implementation of multiple clinical development programs, or one large and complex program, in support of the overall product development plan.
Oversee education for investigators, study site personnel, and AbbVie study staff.
Lead clinical study teams; monitor study integrity; and review, interpret, and communicate accumulating safety and efficacy data.
Partner with Clinical Operations to ensure agreed-upon study enrollment and timelines for key deliverables.
Assess and report serious adverse events in accordance with corporate policy and regulations for assigned protocols.
Own the design, analysis, interpretation, and reporting of scientific content for 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 rigorous, cross-functionally aligned Clinical Development Plans that consider contingencies and alternative approaches.
As Clinical Strategy Team Chair, may supervise matrix team members and represent Clinical Research on Asset Development Teams and their Leadership Boards.
Coordinate and lead scientific and medical activities with internal stakeholders as an in-house clinical expert for relevant molecules and diseases.
May contribute to or lead clinical development work for due diligence or other business development activities.
Partner with Discovery colleagues, as required, to design and implement translational strategies.
Lead clinical activities and opinion-leader interactions related to disease areas; partner with Medical Affairs, Commercial, and other functions in accordance with corporate policies.
Stay current with professional information and technology through conferences, medical literature, and training; may represent AbbVie at key external meetings.
Understand and comply with regulatory requirements for clinical studies and global drug development; serve as a clinical representative in key regulatory discussions.
Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, and other quality standards.