Observational Research Senior Manager

at  Amgen

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

BASIC QUALIFICATIONS:

Doctorate degree and 2 years of related research and scientific experience
Or
Master’s degree and 6 years of related research and scientific experience
Or
Bachelor’s degree and 8 years of related research and scientific experience
Or
Bachelor’s degree and 10 years of related research and scientific experience
Or
High School diploma / GED and 12 years of related research and scientific experience

PREFERRED QUALIFICATIONS:

• Doctorate in Epidemiology or other subject with high observational research content.
• Experience in the design, execution and analysis of observation research studies within Pharmaceutical and/or Public Health settings.
• Experience in research to support drug development.
• Experience working with secondary data systems including administrative claims, EMR and registries.
• Experience in observational research project planning and management.
• Excellent communication, presentation and interpersonal skills.
• Experience working with and leading multi-disciplinary teams.

WHAT YOU WILL DO

Let’s do this. Let’s change the world. Are you searching for a new, dynamic opportunity working with multiple teams to generate real world evidence supporting a wide variety of business needs? If so, we invite you to explore Amgen’s Center for Observational Research.
With a constantly growing demand for information from regulatory and reimbursement agencies, Observational Research (OR) is a critical component in drug development and commercialization. Amgen’s Center for Observational Research (CfOR) partners with internal and external teams to generate real world evidence for multiple partners across the entire product lifecycle. We generate evidence to inform the frequency, distribution, clinical burden, natural history, and clinical course of disease, the design of clinical trials, health resource utilization, drug utilization patterns, and the safety and effectiveness of our medicines.
Let’s do this. Let’s change the world. In this vital role the Observational Research Senior Manager will be a member of the Bone team within CfOR and will be responsible for gathering insights and building collaborations and capabilities to advance the generation, use, and dissemination of real-world evidence (RWE) related to disease state epidemiology, treatment patterns, and medication safety and effectiveness to inform regulatory decision making and enhance access and use of Amgen’s medicines.

RESPONSIBILITIES:

• Lead the design, generation and delivery of RWE evaluating the safety and effectiveness of medicines to inform regulatory decision making (e.g., label expansion/change) and fulfill regulatory requirements across the globe.
• Collaborate in the integrated evidence generation plan to align the conceptualization and design of RWE studies to the strategies and priorities of cross-functional partners.
• Negotiate with cross-functional partners and enhance the use of RWE that can substitute for and/or complement interventional studies to reduce the time and cost of drug development, and answer key business questions.
• Facilitate the dissemination of RWE through publications, congress presentations, trainings, and development of scientific/promotional resources targeting a broad base of external partners (e.g., health care providers, payers, integrated delivery networks).
• Contribute to the development and implementation of innovative analytic methods, and leverage CfOR’s internal data and analytics capabilities and tools to enable rapid, scalable and reproducible RWE.
• Build external partnerships that can provide access to databases that can improve the quality and availability of real-world data in different patient populations and countries, and can execute methodologically rigorous studies.
• Contribute to CfOR’s mission in progressing innovative epidemiological methods and analytical capabilities to support CfOR’s leadership role within Amgen and across industry.