Director Epidemiology, Devices

California
4676
Our client is a pharmaceutical company. They have asked us to assist them in a search for a Director Epidemiology, Devices.

Major tasks and responsibilities include:
  • Leads and develops strategies for device product epidemiologic support globally via observational research and collaboration with other functions for study coordination, execution and dissemination of results.
  • Provides strategic input with cross-functional team into regulatory interactions, for example notified bodies and health authorities globally.
  • Supports product development, launches, surveillance and other related activities.
  • Oversees development of study protocols, database and other analyses, study reports and dissemination research findings.
  • Oversees observational studies to describe and quantify disease epidemiology and real-world usage, patient exposure, safety and effectiveness of devices.
  • Provides subject matter expertise, guidance and direction to internal and external stakeholders.
  • Ensures optimal management of cross-functional projects.
  • Identifies potential risks to project objectives.
  • Ensures scientific integrity and cost-effective project delivery.
  • Participates on advisory committee / device panel meeting preparation teams.
  • Develops and maintains excellent relationships with both internal and external stakeholders, qualified vendors/consultants.
  • Builds partnerships with registries, academic partners, and other external entities to advance research initiatives.
  • Keeps up with up-to-date knowledge of industry best practices in epidemiology and risk management.
  • Maintains keen awareness of regulatory requirements globally, initiatives and advances in device epidemiology especially for the US and EU regions.
  • Oversees critical appraisal and synthesis of relevant epidemiologic literature.
  • Manages direct report(s).

We seek candidates with the following qualifications:
  • A PhD or equivalent in epidemiology or related degree with relevant experience as an epidemiologist is required.
  • Must have a minimum of 5+ years of experience in a pharmaceutical company or a CRO with robust device experience including leading FDA mandated long-term studies.
  • Requires excellent methodological and analytic skills that are
  • Must have excellent communication, presentation and interpersonal skills.
  • The ability to adjust to changing priorities is required.
  • Must be able to navigate and work successfully within a matrix environment.

If interested, please apply directly to this job posting. 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.
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