Amgen Observational Research Sr Mgr in Thousand Oaks, California

This CfOR Senior Manager will have responsibilities for various observational research activities in the Oncology Therapeutic Area (TA) and reports directly to a Therapeutic Area Director. A CfOR Senior Manager is recognized as a strong scientific contributor. The Senior Manager executes or manages research projects involving the analysis of medical claims/EMR and other data sources. These data are used for pharmacovigilance studies to provide safety research across the life cycle of Amgen products; for descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, and emerging market countries; to describe the natural history of disease, and to evaluate treatment patterns for oncology patients. This position will be located at Amgen's Thousand Oaks headquarters.

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 studies by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) was created to address this imperative.

Key Activities for the Senior Manager include, but are not limited to:

  • Contributes to research strategy within the oncology product teams and observational research for the oncology therapeutic area

  • Executes or manages descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, and emerging market countries

  • Executes or manages research projects involving the analysis of medical claims/EMR data sources

  • Executes pharmacovigilance studies

  • Provides safety research support across the life cycle of Amgen products

  • Conducts literature reviews and prepares research reports and scientific manuscripts

  • Supports development of risk management plans

  • Stays abreast of the latest developments in the field of observational research and drug development

  • Promotes awareness, understanding, and use of observational research methods

  • Provides input into observational research department meetings

  • Communicates significant scientific information to a variety of audiences

Basic Qualifications

Doctorate Degree and 2 years of Scientific experience

OR

Master's Degree and 6 years of Scientific experience

OR

Bachelor's Degree and 8 years of Scientific experience

OR

Associate's Degree and 10 years of Scientific experience

OR

High school diploma / GED and 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 observation research studies within Pharmaceutical or Public Health setting

  • Experience in research to support drug development

  • Experience in observational research project planning and management

  • Experience communicating observational research information (written and oral)

  • Experience working in multi-disciplinary teams

  • Managerial experience

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.