The Biomarker & Companion Diagnostics, Medical Head is responsible for creating and overseeing the execution of the Biomarker and Companion Diagnostics Medical Affairs strategy across the Oncology portfolio in the US. The position is Headquarter-based in Lake County, IL and works closely with all the oncology assets being developed with a companion diagnostic or a biomarker strategy.

RESPONSIBILITIES:

• Develop and coordinate the overarching Biomarker and CDx strategy across multiple programs/assets/projects in Oncology
• Lead the development and implementation of biomarker and diagnostic strategies for individual projects and/or therapeutic areas
• Accountable for creation and execution of the companion diagnostic go to market strategy and tactics.
• Responsible for understanding the regulatory requirements related to clinical studies and accountable for complying with those requirements.
• Considers data needs and propose phase 3b/4 studies. Works closely with the oncology development and precision medicine teams to ensure medical affairs input into the development strategies by bringing therapy area evolution insights, educating the internal medical teams on our pipeline and ensures a smooth transition of medical affairs activities from the pipeline team to the relevant go-to-market medical affairs teams.
• Leading Evidence Generation activities support the launch of companion diagnostics for various assets and indications across all oncology portfolio even for assets that are managed by other Therapy Area heads. May act as medical/scientific leader for projects within an area or across several areas.
• May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
• Develops the infield team strategy for companion diagnostics launch and medical education and ensures it’s pull through along with the field directors and the national directors.
• May assist with the scientific review, development, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
• Initiate research projects and drive them to completion, resulting in high quality publications.
• May lead cross functional sub teams responsible for discrete projects within the therapeutic area (individual publications or study collaborations).
• Support drafting regulatory documents for biomarker and CDx to enable prospective analysis in phase 1 and phase 2 studies, including investigational use of candidate companion diagnostic (pre-IVD) assays.
• Establish and maintain internal and external relationships to facilitate medical activities.
• Keeps abreast of technical, scientific, and medical information through attendance of selected Scientific Congresses, literature and other sources of relevant information and acts as a therapeutic area expert in biomarkers and companion diagnostics. Promptly alerts Oncology teams, ASTs, IBTs, Field Medical and other relevant staff of the most critical new information
• Provides scientific/ medical education to TA staff, Medical Field staff, AST and IEST team members related to therapeutic area, biomarker, diagnostic and disease-specific information
   

AUTHORITY AND REPORTING LINES:

• This position reports into the Therapeutic Area VP.

• Advanced education (e.g., MD, PhD, PharmD, PA, NP) required. Residency or/+ post doc highly preferred.
• Typically, 10 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of Oncology therapeutic area required.
• Exhibits leadership attributes that align with company-wide initiatives such as: All for One AbbVie, Clear and Courageous, Make Possibilities Real, Agile and Accountable, and Decide Smart and Sure.
• The ability to influence without authority.
• Demonstrated ability to manage multiple priorities.
• Teamwork is a mandatory requirement as it involves the ability to work in cross-functional teams.
• Management and leadership experience at project level, experience with strategic initiatives/issues.
• Proven leadership skills in a cross-functional team environment. US and International experiences are a plus.
• Ability to interact externally and internally to support global business strategy.
• Ability to run a clinical study or medical affairs team independently with little supervision.
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Must possess excellent oral and written communication skills.
• Solid knowledge of the pharmaceutical environment and the role of Medical Affairs to advance the medical and scientific objectives of a pharmaceutical company.
• Demonstrated expertise in the scientific methods applied to clinical research and current legislative/regulatory controls applicable to this research.