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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Senior Medical Director, Global Medical Affairs, Biomarkers and Companion Diagnostics

Lake County, Illinois Req ID 2208165 Category Medical Division AbbVie

Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products — Imbruvica, Venclexta, and Empliciti — and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer.


The Scientific Director, GMA, Biomarkers & Companion Diagnostics is responsible for supporting the execution of the Biomarker and Companion Diagnostics Medical Affairs strategy across the Oncology portfolio. The position is Headquarter-based in Lake County, IL and works closely with the regions and countries for coordination of biomarker and companion diagnostic activities and strategy & execution.


Essential Duties and Job Functions:

  • Develop and coordinate the overarching Biomarker and CDx strategy across projects in Oncology
  • Lead the development and implementation of biomarker and diagnostic strategies for individual projects and/or therapeutic areas
  • Responsible for understanding the regulatory requirements related to clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
  • 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.
  •  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.
Qualifications:

For the Scientific Director level, the following is required:

  • Advanced education (e.g., MD, PhD, PharmD) required. Residency or/+ post doc highly preferred.
  • Typically 10 yrs experience in the pharmaceutical industry or equivalent; substantial understanding of Oncology therapeutic area required.
  • Management and leadership experience at project level, experience with strategic initiatives/issues.
  • Proven leadership skills in a cross-functional team environment. International experiences 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.

For the Associate Scientific Director level:

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 20 % of the Time
Job Type: Experienced
Schedule: Full-time
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