Observational Research, Senior Manager (Oncology

Career Category

Research

Job Description

Join Amgen's Mission of Serving Patients

Let's do this. Let's change the world. Do you like to work within scientific and commercial teams to generate real-world evidence (RWE); RWE that supports an ever-changing landscape of unique and evolving business needs? If so, we invite you to explore Amgen's Center for Observational Research (CfOR).

Here in CfOR we are a team of scientists. We conduct observational research across the drug development and commercialization lifecycle. The data we produce informs clinical trial design, supports regulatory decision making and aids in the commercialization of our products. Study designs range from evaluating disease frequencies and current standards of care to understanding the safety and effectiveness of our medicines.

We partner with internal and external teams to produce the highest quality RWE to enable rapid decision making. The goal of everything we do is to contribute to the development of the best possible medicines and bring these medicines to patients as quickly as possible.

Your role as an Observational Research Senior Manager will be to lead projects and teams in support of that mission: to serve patients. You will be gathering insights and building collaborations and capabilities to advance the generation, use, and dissemination of RWE. This position will support the oncology therapeutic area and require you to be an effective communicator, critical thinker, and adept scientist.

Your ability to execute on the science and deliver results efficiently and effectively will be the key to your success.

• 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.

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Senior Manager with these qualifications.

• Doctorate degree and at least 2 years of related research and scientific experience OR
• Master's degree and at least 6 years of related research and scientific experience OR
• Bachelor's degree and 8 years of data sciences and scientific experience OR
• Associate's degree and 10 years of data sciences and scientific experience OR
• High school diploma / GED and 12 years of data sciences and scientific experience

• Doctorate degree in epidemiology or subject area with high observational research content.
• Experience in the ideation, design, execution and delivery of oncology observational research studies.
• Excellent communication, presentation and interpersonal skills.
• Experience working with and leading multi-disciplinary teams.
• Research experience in project planning and study management.
• Research experience within the pharmaceutical and/or public health setting.
• Research experience working with secondary data systems (e.g. administrative claims, EHR, disease and/or drug registries).

As we work to develop…