Skip to main content

Search jobs

Search jobs

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.

Therapeutic Area Lead, US Medical Affairs, Women's Health

Lake County, Illinois Req ID 2204500 Category Medical Division AbbVie

The Therapeutic Area (TA) Lead is responsible for leading a team in Women's Health in developing and executing the Medical Affairs strategy for an AbbVie asset in development or a marketed product. Responsible for practical and clinically meaningful data strategy and delivery to inform clinical use and transform standard of care. Aligning all internal parties on Medical Benefit-Risk Evidence based positions. Deeply understanding the patient journey and apply insights into determining the medical need. Expected to work closely with Clinical Development and Asset Teams to ensure that global customer insights and health care practices, current and future are incorporated in the clinical development and regulatory plans. Provide strategic medical input into core brand strategies, and to support medical activities and market access.

Key Responsibilities Include: 

  • Actively participates in advancing and communicating corporate and US Medical Affairs philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for the Women’s Health Medical Science Liaison team through the National MSL Director.  Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff.
  • Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility 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.
  • Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
  • 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. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
  • Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. 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.
  • Oversees 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. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information.
  • May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
  • Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
  • Accountable for the medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides strategic guidance to cross-functional team members related to the medical content. Maintains oversight of TA specific medical content included in commercial communications.
Qualifications:
  • Advanced degree (MD, PhD, DO) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Relevant therapeutic area clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required.
  • OB-GYN, obstetrician-gynecologist highly preferred for the role.
  • 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. Advanced academic qualification is warranted.
  • Typically 8 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
  • Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex medical affairs team(s) independently.
  • Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty. Must have basic understanding of Pharmacovigilance practices for Clinical Development programs.
  • Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives.
  • Works independently and leads team.
  • Can address complex problems within discipline or across several projects.
  • Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 15 % of the Time
Job Type: Experienced
Schedule: Full-time
ABBVIE

Most recent jobs

Sign up for job alerts

Join our talent network and receive AbbVie news and job alerts to your inbox.

Interested InPlease select a category or location option. Click “Add” to create your job alert.

Our Terms of Use, Cookie Policy and Privacy Policy explain how we collect and use information about you and the rights you have. By submitting your information, you acknowledge you have read those documents and consent to receive SMS communications and email jobs alerts from AbbVie.

Recently viewed jobs

You have not viewed any jobs recently.

Phishing scam alert

As an online job seeker, you could be a target of cyber (online) thieves seeking to secure personal information from you by sending you “phishing” messages.

Please be alert to and protect yourself from phishing scams. Find out how you can avoid being a victim of job phishing scams.

For Internal Candidates only - Notice of Filing of Labor Condition Application

Equal Employment Opportunity | Reasonable Accommodation