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Observational Research, Senior Manager (Obesity)

Amgen
over 2022 years ago
Remote friendly (United States)
United States
Clinical Research and Development

Role Summary

Your role as an Observational Research Senior Manager will be to lead projects and teams in support of Amgen’s mission to serve patients. You will gather insights and build collaborations to advance the generation, use, and dissemination of real-world evidence (RWE). This position supports the obesity therapeutic area and requires you to be an effective communicator, critical thinker, and adept scientist. In a rapidly evolving disease landscape, your ability to execute on the science and deliver results efficiently will be essential.

Responsibilities

  • Develop study proposals using real-world data to address key business questions as identified within the cross-functional teams. For example, identifying an appropriate database and collaborator to evaluate disease severity in a particular patient population.
  • Lead the design, completion, and delivery of RWE. For example, build a study to evaluate the safety and effectiveness of an Amgen medicine to inform a regulatory decision (e.g., label expansion/change) and fulfill a global or regional regulatory requirement.
  • Facilitate the dissemination of RWE through key presentations, publications and/or trainings. For example, develop a scientifically based promotional resource targeting a broad spectrum of external partners (e.g., health care providers, payers, integrated delivery networks).
  • Collaborate on the development of an integrated evidence generation plan for the product team. This would require discussion and alignment on the conceptualization and design of real-world data studies focused on the strategies and priorities of your cross-functional partners.
  • Contribute to the development and implementation of innovative analytic methods. For example, leverage CfOR’s internal data and analytics center to complete a study evaluating the comparative effectiveness of an Amgen medicine vs. an appropriate comparator.
  • Partner with cross-functional colleagues to enhance the use of RWE. For example, develop a substitute for and/or a complement to an interventional study to reduce the time and cost of a particular drug development goal.
  • Build external partnerships to increase the opportunities to use real-world data to support the product team. For example, identify an external partner who has access to data that can improve the quality and availability of information from different patient populations and countries.
  • Contribute to CfOR’s mission in progressing innovative epidemiological methods and analytical capabilities, using real-world data, to enable rapid and informed decision making bringing better medicines to patients faster.

Qualifications

  • Required: Doctorate degree and at least 2 years of related research and scientific experience OR
  • Required: Master's degree and at least 6 years of related research and scientific experience OR
  • Required: Bachelor's degree and 8 years of data sciences and scientific experience OR
  • Required: Associate’s degree and 10 years of data sciences and scientific experience OR
  • Required: High school diploma / GED and 12 years of data sciences and scientific experience
  • Preferred: Doctorate degree in epidemiology or subject area with high observational research content.
  • Preferred: Experience in the ideation, design, execution and delivery of observation research studies.
  • Preferred: Excellent communication, presentation and interpersonal skills.
  • Preferred: Experience working with and leading multi-disciplinary teams.
  • Preferred: Research experience in project planning and study management.
  • Preferred: Research experience within the pharmaceutical and/or public health setting.
  • Preferred: Research experience working with secondary data systems (e.g. administrative claims, EHR, disease and/or drug registries).