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Global Medical Affairs Director Virology Pipeline

Employer
AbbVie
Location
Lake County, IL, United States
Start date
Jan 22, 2021

View more

Discipline
Clinical, Medical Affairs, Science/R&D, Virology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

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 .

  • Develops, reviews and follows up on clinical studies and medical projects initiated within the Virology Therapeutic area that will include COVID and HIV (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.) at the regional/local level.
  • All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams.
  • Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies.
  • May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc...) as they relate to on-going medical affairs projects. May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
  • May assist in scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource.
  • Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
  • May represent the medical function on cross-functional integrated teams for medical affairs 'activities. May represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
  • 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.
  • Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.

Qualifications
  • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with the Virology therapeutic specialty to include COVID and or HIV in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
  • National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred.
  • Minimal clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
  • 1-2 years of experience is preferred.
  • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
  • May possibly have performed protocol design in the academic environment or in the pharmaceutical industry and/or acted as an assistant PI or PI.
  • Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects/schedules, etc.
  • Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
  • Ex-Us: At least one further major international language is preferred.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 25 % 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.

Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Company info
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
US

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