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Senior Director, Epidemiology

Reference Number: 3970
Location: IL

Our client is a global, research-driven biopharmaceutical company. They have asked us to assist them in their search for a Senior Director, Epidemiology.

Major tasks and responsibilities will include:

  • Defines strategy and vision for pharmacoepidemiologic studies and reports.
  • Develops high-level processes for selecting, designing, and analyzing data from high-quality pharmacoepidemiologic studies and reports
  • Contributes to the design, management, and analysis of observational studies, including registries.
  • Provides formal critical appraisal of observational studies and observational study protocols through active participation in cross-functional committees (as assigned) and in response to requests through the PSTs.
  • Provides strategic epidemiologic support through the PSTs and in collaboration with Pharmaceutical development, Medical Affairs, HEOR and Statistics.
  • Provides epidemiologic analysis to support knowledge gaps, as needed (background disease epidemiology, support signal evaluations, etc.).
  • Offers epidemiologic support for the conduct of benefit-risk assessments, and prepares the epidemiologic sections of the Risk Management Plans.
  • Supports product launches through strategic contribution to the assessment of need for use of observational data, evaluation of data sources, design, and the conduct of observational studies for new or recently launched products. Proactively prepares for exposure in the real world based on historical background and knowledge of the disease and the population treated, including the establishment of baseline databases in the population with the disease among other examples.
  • Maintains expertise in current and future policies, practices, trends, developments, etc. relevant to the company and the therapeutic area.
  • Applies epidemiology principles to industry issues, research and development, impact on Pharmacovigilance, methods of adverse event evaluation processes.
  • Maintains a high-level understanding of U.S/international safety regulations and current regulatory safety review processes.

We seek candidates with the following qualifications: 

  • Advanced degree (PhD, MPH, MSc) in Epidemiology or relevant discipline is required.
  • Must have a minimum of 7 years of applied epidemiology experience.
  • Requires a minimum of 5 years of pharmaceutical industry experience.
  • A minimum of 3 years of line management experience, or significant strategic management experience of complex projects is required.
  • Must have the ability to negotiate with internal and external groups.
  • Requires significant knowledge and solid understanding of quality assurance, global regulations, legal and regulatory functions, and financial implications of decisions.

If interested, please email your resume as a Word attachment to us, reference 3970.  No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.