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Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference

Amgen
Remote friendly (United States)
United States
Clinical Research and Development

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
    • Master’s degree and 8 years of scientific experience or
    • Bachelor’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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