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Director – Immunology Evidence Strategy – Biopharmaceuticals Medical

Director – Immunology Evidence Strategy – Biopharmaceuticals Medical

CompanyAstraZeneca
LocationGaithersburg, MD, USA
Salary$193281.6 – $289922.4
TypeFull-Time
DegreesMaster’s, PhD
Experience LevelSenior, Expert or higher

Requirements

  • Substantial experience in pharmacoepidemiology and/or disease epidemiology
  • Ph.D. or equivalent in epidemiology or related health science field and substantial experience in the health care environment
  • Alternatively, an MSc or MPH with consolidated experience in the health care environment
  • Experience in the pharmaceutical industry or in closely related academic epidemiological research
  • Experience managing complex medical evidence plans
  • Able to provide critical appraisal to study designs and published studies
  • Sustained productivity in epidemiological research as manifested by successful design, execution, and publication of original epidemiological research relevant to drug discovery and development (e.g., drug safety) or commercialization, in a peer-reviewed journal
  • Sustained record of epidemiological productivity at a strategic as well as an operational level
  • In depth experience in utilizing secondary real-world data
  • Recognition by the external scientific communities as an expert in the application of epidemiology to areas relevant to drug development and commercialization
  • Able to effectively engage and consult with recognized key external scientific experts.

Responsibilities

  • Describe the unmet need and demonstrate the value of a new medication to stakeholders using real-world primary and secondary data sources
  • Set the tactical RWE plan together with the Evidence Strategy Senior Director and contribute to the annual business strategy planning cycle
  • Act as independent scientific leads for the planning and execution of RW studies, both primary and secondary
  • Consult on observational methods
  • Perform critical appraisal and synthesis of relevant epidemiological literature
  • Design, initiate, manage, conduct, analyze, and report epidemiological studies, including observational and interventional studies
  • Develop medical evidence plans to identify critical knowledge gaps
  • Interact with internal and external customers to ensure appropriate identification of evidence gaps and communication of results
  • Provide epidemiological support for responses to questions posed by regulatory authorities
  • Design and conduct primary data collection studies implemented through external service providers
  • Negotiate time frames for task completion and ensure tasks are carried out as agreed
  • Support medical and clinical objectives and work closely with commercial partners
  • Educate colleagues in the principles and practice of epidemiology
  • Participate in the development of complex medical evidence strategies and drive decisions within a complex matrix drug team environment

Preferred Qualifications

    No preferred qualifications provided.