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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. Join us.

Senior Manager Global Observational Program Management

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work in CfOR Operations and lead the study management and procedures within CfOR. Recognized as a scientific contributor and an owner or contributor for SOPs governing observational research. Reporting to the Director of Development Operations, you will be responsible for resource and portfolio assessment, and conducting advance planning and anticipating future resource, funding and decision making

• Supports the management of research strategy within the product team and observational research TA specifically by facilitating the conduct of ancillary/secondary studies with external organizations (GCPM-OR, Medical, GCPM-TA); this may include protocol development, oversight of Statistical Analysis Plan, and management of regulatory requirements for these studies

• Responsible for oversight of high-quality observational research to support product strategy within TA.

• Supports relationships with key leaders including Observational Research Review Group (ORRG); ensures that operating procedures for ORRG align with observational study mission.

• Develop processes including innovative ways to improve efficiencies; works with the Product Teams within CfOR to ensure that SOPs align with best practices.

• Provides input into observational research department meetings

• Stays abreast of the latest developments in the field and drug development and supplies to the field including regulatory requirements globally.

• Supervise the quality and scientific integrity of observational clinical operations at a global level

• Collaborate with cross functional partners to ensure timely and on budget execution of study results and leads the Operations Team to drive effective decision making

• Plan and lead the reporting of selected clinical studies conducted by Center for Observational Research through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/results.

• Ensure implementation and conduct of studies in accordance with SOPs and ICH-GCP guidelines

• Owner of the Observational Research Standard Operational Procedures

• Support the development and delivery of key components of the Evidence Generation Plan

• Support complex development decision making throughout product development cycle. The Sr. Manager leads teams through a qualitative approach to build strategic development options through framing, issue raising and classification, decision hierarchy, and strategy table generation

• Identify value measures, trade-offs, risks, and gaps in development strategy

• Bring the right functions together at the right time and integrate cross-functional input to facilitate end–to-end observational research development.

• Objective leader that influences the adoption of novel or innovative ways and provides strategic leadership required to drive year over year efficiency through yield and capacity projects on site.

• Building and maintain positive collaborations; communicating, seeking advice, and facilitating critical business decisions.

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a program leader with these qualifications.

Basic Qualifications

• Doctorate degree and 2 years of research and program management experience Or

• Master’s degree and 6 years of research and program management experience Or

• Bachelor’s degree and 8 years of relative experience Or

• Associate’s degree and 10 years of relative experience Or

• High school diploma / GED and 12 years of relative experience

Preferred Qualifications

• Masters or Doctorate level degree in observational research operations and 5 years of research and program management experience.

• Experience in the strategic planning, operations, and budgeting of observational research studies within Pharmaceutical or Public Health settings.

• Clinical Study Management experience.

• Experience in project planning, management and observational research to support drug development

• Knowledge of regulations globally.

• High proficiency with Microsoft Office and SharePoint, Tableau or other data visualization tools and Observational research databases.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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