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Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference

Amgen
Full-time
Remote friendly (United States)
United States
Clinical Research and Development

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Role Summary

Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference. Lead a Pharmacovigilance Epidemiology and Causal Inference team within the Data and Analytics Center (DAC). Primarily located on the Amgen campus in Thousand Oaks, CA, with potential remote opportunities.

Responsibilities

  • Effectively leads, develops, and mentors a team of scientists
  • Design and execute studies to support evidence generation, including identifying patient populations, assessing disease burden and resource utilization, obtaining product registrations and label expansions, meeting post-marketing requirements/commitments, and product differentiation
  • Find opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development
  • Influence cross-functional team members on the use and timing of non-interventional research to answer high-priority strategic business questions
  • Leverage real-world data and analytic approaches to inform high-value business decisions for multiple stakeholders
  • Track priorities and align resources accordingly
  • Contribute to the mission of CfOR, advancing innovative methods and analytical capabilities
  • Participate in initiatives to improve CfOR capabilities and provide input to CfOR meetings
  • Contribute to the development of product and CfOR strategies
  • Develop and maintain relationships with key leaders in observational research

Qualifications

  • Basic Qualifications:
    • Doctorate degree and 4 years of scientific experience or
    • Masterโ€™s degree and 8 years of scientific experience or
    • Bachelorโ€™s degree and 10 years of scientific experience
  • In addition, at least 4 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or resource allocation
  • Preferred Qualifications:
    • Doctorate in Epidemiology or related field with observational research focus
    • Experience designing, executing, and analyzing observational research studies in Pharmaceutical or Public Health settings
    • Experience in research to support drug development and observational research project planning/management
    • Excellent verbal and writing communication and interpersonal skills
    • Experience working in multi-disciplinary teams

Skills

  • Leadership and people management
  • Observational research design, execution, and analysis
  • Real-world data analytics and causal inference methodologies
  • Cross-functional collaboration and strategic thinking
  • Strong communication and writing abilities

Education

  • Doctorate preferred in Epidemiology or related field; alternative with strong observational research content considered

Additional Requirements

  • Ability to collaborate with Global Patient Safety and Global Regulatory Affairs and Strategy at leadership levels
  • Willingness to work in a hybrid/remote-capable environment and travel as needed for collaboration
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