Senior Medical Director, Benefit-Risk Management

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Mar 23, 2018
Ref
1708694
Required Education
Doctorate/PHD/MD
Position Type
Full time
Key Responsibilities Include:

  • Serve as SME/consultant to PST/ADT to advise on benefit-risk (B/R) assessments and risk management (RM) strategies to support drug development programs, new product marketing applications and marketed products. Work in a collaborative manner to facilitate incorporation of cross-functional perspectives into B/R assessments and RM strategies.
  • Work in a collaborative manner with statistical colleagues to develop graphical displays of B/R assessments and advise teams on use of quantitative B/R analysis approaches.
  • Support preparation / updating of RMPs for assigned products; support affiliates with development of local RMPs/annexes.
  • Understand assigned products' pharmacology and benefit/risk profile; understand precedence analysis and apply to BRM deliverables.
  • Prepare and/or review B/R and RM sections in clinical development, pharmacovigilance or regulatory documents.
  • Drive buy-in, adoption, and compliance with BRM processes across AbbVie.
  • Develop risk minimization measures including user testing/human factors testing.
  • Develop global/US implementation strategy for risk minimization programs.
  • Develop effectiveness evaluations for a risk minimization measures/programs; apply evaluation outcomes to define corrective measures when needed.
  • Workin a collaborative manner with office of QPPV to ensure affiliate compliance with execution of RM strategies.
  • Ensure development and maintenance of education and communication materials for BRM processes and activities.
  • Evaluate impact of new PV legistlation on BRM activities.
  • 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.
  • Support preparation of publications relating to BRM processes and activities.
  • Anticipate emerging issues and develop solutions relating to BRM processes and deliverables.
  • Support inspection readiness activities.
  • Update / algin, SOPs/WIs/processes across AbbVie to ensure seamless execution of BRM activities. Serve as SME to support development of tools and templates to execute BRM processes.
Qualifications:

  • MD / DO with 2+ years of residency with patient management experience
  • Non-MD will be considered in the Scientific Director hierarchy
  • 5 years of experience in the pharmaceutical industry
  • Experience in pharmaceutical clinical development highly preferred
  • Ability to lead cross-functional team in a collaborative environment
  • Fluency, both written and oral, in English
  • Evaluate and make independent decisions
  • Work collaboratively and lead cross-functional teams
  • Write, review and provide input on technical documents
  • Effectively analyze and guide analysis of clinical data and epidemiological information
  • Effectively present recommendations / opinions in group environment both internally and externally
  • Master Public Health is preferred in addition to MD / DO, not required
Equal Opportunity Employer Minorities/Women/Veterans/Disabled