Medical Director/Scientific Director, Medical Affairs - Precision Medicine

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

*Preferred location is Lake County, IL (hybrid 3 days per week). Will consider remote candidates. 

*Position title will be based on qualifications listed below.

Purpose

• Global Medical Affairs (GMA) leader accountable for the creation and oversight of the execution of our Companion Diagnostics (CDx) Global Medical Affairs (GMA) objectives.
• Oversees GMA CDx activities ensuring seamless communication and execution on Oncology early CDx launch strategies.
• Provide strategic support to and guidance to the therapeutic area team in developing, aligning, and executing our early CDx strategies with our Oncology pipeline assets strategies.

Responsibilities

• Develop and coordinate the overarching CDx strategy across multiple early oncology assets to ensure optimal launch planning of our assets.
• Lead the development and implementation of diagnostic strategies for individual assets.
• Serve as a key member and content expert in the Pipeline Commercialization Model.  Serve as a key member of the Asset Strategy Teams and Integrated Evidence Teams to shape the development and early launch planning of our companion diagnostics for various assets and indications across the oncology pipeline.
• Build together with clinical development and precision medicine a comprehensive plan to address the evidence, educational, and standard of care gaps and ensure GMA input into the CDx development strategies. 
  • Responsible for understanding the different regulatory requirements across the geographical areas related to clinical studies and accountable for complying with those requirements.
  • 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.
• Accountable for the education of AbbVie’s medical teams on our CDx pipeline and ensures a smooth transition of GMA activities from the pipeline CDx team to the relevant go-to-market medical affairs CDx launch teams.
  • Responsible for the development of CDx educational materials and educating affiliate office and in-field teams.
  • Establish and maintain internal and external relationships to facilitate medical activities.
• 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.

Medical Director Qualifications:

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
• Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
• Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
• Must possess strong leadership skills, ability to influence without authority in cross-functional teams, ability to prioritize effectively, effectively enable coaching, mentoring and conflict resolution.
• Prior US specific experience with a companion diagnostic or complementary diagnostic preferably in oncology space is a must.
• Prior experience with US specific testing landscape stakeholders including diagnostic partners, academic and community pathologists, oncologists with precision medicine expertise and reference laboratory stakeholders is a must.
• Medical affairs experience with US focus preferred, but experience in a diagnostic company, reference laboratory or other functions in pharma will be considered.
• Ability to run a clinical study independently with little supervision.
• Ability to interact externally and internally to support global business strategy.
• Must possess excellent oral and written English communication skills.

Scientific Director Qualifications:

• Advanced Degree in related science field, (e.g. MS Pharm, PharmD, MD).
• 10+ years of work experience in the pharmaceutical industry and drug development.  Experience in executional Medical Affairs roles, regulatory, HEOR, pharmacovigilance or clinical development preferred.
• 5+ years management experience or position requiring ability to influence cross-functionally. 5+ years of significant leadership experience required to manage multifunctional responsibilities preferred.
• High degree of empathy for the patient and implements tactics that ultimately impact quality of patient care and access to medicines.
• Motivational approach, open to new ideas and the ability to connect the dots within and across groups and functions
• Proven leadership skills to form and implement cross-functional matrix teams.  Ability to model performance management leadership behaviors related to the management level
• Strong credibility and ability to establish and maintain productive relationships with a variety of audiences, including government regulators, the scientific community in both academic and private sector environment and other key stakeholders.
• Possesses an array of influencing skills with high emotional intelligence and interpersonal savvy. Can lead and inspire teams inside and outside of own organization to deliver on business priorities.
• Works across the matrix proactively, partnering with people across functional and geographical boundaries while driving to an outcome.  Co-creates strategy with other functions. Gets the team and cross-functional stakeholders energized about the best solution for the broader AbbVie. Manages relationships adeptly.
• Demonstrated organizational and administrative skills; able to independently manage workload, set personal and team priorities and adjust as needed
• Role model of strong interpersonal and teambuilding skills; able to create a shared vision and productively manage conflict between team members with diverse interpersonal styles; able to deliver effective coaching and feedback. Remains calm and effective despite challenging situations, complexity, multiple priorities, and ambiguity.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation 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.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html