Amgen Observational Research Mgr in Seattle, Washington
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
Master's degree and 3 years of scientific experience
Bachelor's Degree and 5 years of scientific experience
Associate's degree and 10 years of scientific experience
High school diploma / GED & 12 years of scientific experience
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.