Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • Seattle

Description

Observational research (OR) makes important contributions to drug development, commercialization, and safety evaluation. OR contributes 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 effectiveness of therapies. There is increasing demand for information from OR-based evidence by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) was created to address this imperative. This CfOR Manager will have responsibilities for various research activities in the Data and Analytics Center (DAC) Safety and Pharmacoepidemiology team and reports directly to the Patient Exposure Lead. A 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 enhance 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 all 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 manages 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

Basic Qualifications

Doctorate degree

OR

Master’s degree and 3 years of scientific experience

OR

Bachelor’s Degree and 5 years of scientific experience

OR

Associate’s degree and 10 years of scientific experience

OR

High school diploma / GED & 12 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

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

About the company

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.

Companies in this sector

Hives where you can find this job offer