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Senior Medical Director/ Senior Scientific Director, Benefit Risk Management, Immunology -

Employer
AbbVie
Location
Lake County, Illinois
Start date
Sep 16, 2023

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Discipline
Clinical, Drug Safety/Pharmacovigilance, Science/R&D, Immunology
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work
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Job Details

The Senior Medical Director is responsible for promoting excellence in structured benefit-risk (B/R) assessment and patient-centered risk management (RM) in support of new product submissions and product lifecycle management. 

Responsibilities:

  • Understand and apply expertise related to pharmacovigilance, clinical development, benefit-risk assessment, and risk management to effectively decide and oversee BRM activities and deliverables.
  • Advise AST /PST on benefit-risk assessments and risk management (RM) strategies / plans to support product development programs, new product marketing applications and marketed products.
  • Lead and facilitate incorporation of cross-functional perspectives into B/R assessments and RM strategies.
  • Collaborate with statistical colleagues to develop graphical displays of B/R assessments and advise teams on use of quantitative B/R methodology.
  • Advise preparation/updating of RMPs/local RM documents for assigned Therapeutic Area(s); specifically advise on pharmacovigilance plan (in partnership with epidemiology) and on risk minimization plan. Review RMPs for quality and alignment with current regulations.
  • Oversee BRM Lead on strategies and then design / build/ test/ implement / assess phases of additional risk minimization measures / REMS.
  • Effectively write, review, and provide input on technical documents and regulatory deliverables relating to Benefit Risk Management (BRM).
  • Lead and set strategy for innovative benefit-risk projects such as patient preference studies.
  • Lead BRM publication strategy for assigned Therapeutic Area(s).
  • Advise on inspection readiness activities relating to BRM.
  • Understand impact of new PV legislation/policies on BRM activities and drive change to enhance BRM processes.
  • Participate in pharmacovigilance/cross-functional or external initiatives to develop and implement policies and procedures (aligning with requirements of regulatory authorities, global polices and best practices) relating to BRM.
  • Proactively engage, inspire, coach and mentor team and colleagues.
  • Stays abreast of professional BRM information and technology through conferences, medical literature and other available training, to augment expertise in the BRM area.  May represent AbbVie at key external meetings.

  • Advanced Degree PhD, MD required. Residency or additional post doctorate experience is highly preferred.
  • Typically, 10 plus years’ experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
  • Management or leadership experience at the program level, experience with strategy development; senior staff role within a TA. Proven leadership skills in a cross-functional global team environment and international experience is a plus.
  • Ability to interact externally and internally to support global business strategy.
  • Knowledge of clinical development, safety and B-R analysis, regulatory requirements, and experience in developmental B-R strategy.
  • Must have an understanding of the Pharmacovigilance practices.
  • Ability to interact externally and internally to support global business strategy. Most possess excellent oral and written communication skills.
  • Can address 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 B-R analysis of situation or data requires an in-depth evaluation of various complex factors.
  • Exercises judgment within broadly defined B-R practices and policies in selecting methods and techniques for obtaining solutions.

    • AbbVie 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.


    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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