Executive Medical Director, Oncology Early Development

Overview Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs, with principal responsibility for clinical strategy including the end-to-end Clinical Development Plan(s). Participates in and may lead cross-functional teams to generate, deliver, and disseminate high‑quality clinical data supporting overall product scientific and business strategy. Responsibilities Lead and demonstrate ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project‑related education of investigators, study site personnel, and AbbVie study staff. Hold overall responsibility for leading clinical study teams, monitoring overall study integrity, and reviewing, interpreting, and communicating accumulating data pertaining to safety and efficacy of the molecule. Work with Clinical Operations to ensure agreed‑upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for assigned protocols. Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs. May serve on or chair Clinical Strategy Team(s), responsible for development of a rigorous, cross‑functionally‑aligned, vetted Clinical Development Plan spanning all phases of development (Ph1–Ph3). In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs). Serve as an in‑house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contribute in partnership with Discovery colleagues to design and implementation of translational strategies. Act as clinical lead and actively solicit opinion‑leader interactions related to the disease area(s); partner with Medical Affairs, Commercial and other functions as required, consistent with corporate policies, to ensure that broad cross‑functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Stay abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings. Understand the regulatory requirements related to the clinical studies and global drug development and be accountable for complying with those requirements. Serve as a clinical representative for key regulatory discussions. Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Qualifications Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non‑US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable. At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent. Ability to run a complex clinical research program independently. 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 externally and internally to support a global scientific and business strategy. Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols. Must possess excellent oral and written English communication skills. Ability to exercise judgment and address complex problems and create solutions for one or more projects. Additional Information Compensation: The range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Benefits: We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. Long‑term incentive: This job is eligible to participate in our long‑term incentive programs. Equal Opportunity Employer Statement AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. #J-18808-Ljbffr Initial Therapeutics, Inc.