Senior Medical Director, Global Medical Affairs, Biomarkers and Companion Diagnostics
AbbVieLake countyUpdate time: April 27,2022
Job Description
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. 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: PhD preferred but not required PhD with 5+ years of relevant experience in pharmaceutical and/or diagnostics companies. BS or equivalent education with 12+ years of relevant experience in pharmaceutical and/or diagnostics companies; MS or equivalent education with 10+ years of relevant experience in pharmaceutical and/or diagnostics companies Should have experience managing Biomarker and/or CDx aspects of early and late stage clinical programs including sample management, working with CROs and Diagnostic partners Experience managing a team providing support for biomarker and CDx programs Experience managing budgets, negotiating contracts with external vendors Excellent verbal communication and interpersonal skills are required Strong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment. Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel Yes, 20 % of the Time Job Type Experienced Schedule Full-time Job Level Code D Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

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