Observational Research Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Observational Research Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will have responsibilities for various research activities related to the obesity pipeline products and report directly to the lead for the Safety and Pharmacoepidemiology team in the Data and Analytics Center (DAC).

Observational research (OR) makes important contributions to drug development, commercialization, and safety evaluation. OR gives evidence regarding the frequency and distribution of disease, the natural history and clinical burden of disease, the design of clinical trials, cost and utilization patterns, and the safety and efficacy of therapies. There is growing demand for information from OR-based evidence by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) was built to address this imperative.

The CfOR Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer reviewed journals or for internal reports that address the company’s mission.

This position may be located at Amgen's Thousand Oaks headquarters or be remote.

Key Activities include, but are not limited to:

• Designs and implements models to estimate patient exposure to Amgen marketed products.
• Designs and implements retrospective database studies in support of safety and pharmacovigilance.
• Provides epidemiological input to worldwide regulatory submissions such as PSURs and RMPs.
• Executes or leads research projects involving the analysis of multiple databases
• Provides safety research support across the life cycle of Amgen products
• Supports development of risk management plans
• Conducts literature reviews and prepares research reports and scientific manuscripts
• Stays abreast of the latest developments in the field of observational research and drug development
• Promotes awareness, understanding, and use of observational research methods
• Supports relationships with key leaders in observational research
• Provides input into observational research department meetings
• Communicates significant scientific information to a variety of audiences

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master's degree and 2 years of scientific experience

Or

Bachelor's Degree and 4 years of scientific experience

Or

Associate’s degree and 8 years of scientific experience

Or

High school diploma / GED & 10 years of scientific experience

Preferred Qualifications:

• Doctorate in Epidemiology or other subject with high observational research content
• Experience in the design, execution, and analysis of observational research studies within a pharmaceutical or public health setting
• Experience in observational research project planning and management
• Experience communicating observational research information, written and oral
• Experience working in multi-disciplinary teams
• Record of publications in observational research or clinical journals

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base s