AbbVie

Therapeutic Area Lead, LATAM, Dermatology

Employer
AbbVie
Location
Lake County, IL, United States
Posted
Sep 05, 2020
Ref
2002887
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 .

Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety. Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access. Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training.

  • Develops, reviews and follows up on clinical studies and medical projects initiated within the relevant therapeutic area (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 relevant therapeutic specialty in an academic or hospital environment highly preferred. 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.
  • Medical Affairs experience in pharma with therapeutic experience in rheumatology, dermatology or immunology 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 (Spanish and/or Portuguese) is preferred.
  • Position is located in Lake County, IL

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 50 % 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.