Observational Research Senior Mgr
Location:
Thousand Oaks , California
Posted:
February 07, 2017
Reference:
R-33602
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.


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