Observational Research, Director (Obesity)

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Job Description

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.

Observational Research, Director (Obesity)

We are currently hiring for an Observational Research Director to support the obesity franchise. The growing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with industry-leading capabilities to generate generates RWE that supports business needs across a product’s lifecycle. CfOR scientists partner with internal collaborators and industry experts to craft, conduct, interpret, and publish observational research that advises decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines.

CfOR studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of the disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions.

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What you will do

Let’s do this. Let’s change the world. In this vital role you will lead a team of epidemiologists to conceptualize, design, conduct, analyze, interpret and publish observational research supporting drug development programs and regulatory submissions, investigating post-marketing safety and effectiveness.

Key Activities Include:

• Effectively lead, develop, and mentor a team of scientists
• Be the technical expert in a cross-functional team to: identify evidence needs; develop the RWE plan to support the product development and commercialization strategy; and develop, maintain and expand a portfolio of observational research activities to support these strategies
• Design and execute studies to support evidence generation such as identifying appropriate 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 as to the appropriate use and timing of non-interventional research to answer high-priority strategic business questions
• Leverage real-world data and …