Observational Research Manager
Amgen is searching for an Observational Research Manager (Epidemiology) who will be responsible for research activities in the Non-Oncology therapeutic area (TA) and report directly to a Product Lead.
Observational Research (OR) makes important contributions to drug development, commercialization and safety evaluation. Observational Research 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. 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.
Key activities of the Observational Research Manager include:
- Contributing to research strategies within product teams and observational research TA.
- Executing and managing descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, Asia and emerging market countries.
- Executing and managing research projects involving the analysis of multiple types of data including medical claims, EMR and prospective observational cohort studies.
- Executing pharmacovigilance studies.
- Providing safety research support across the life cycle of Amgen products.
- Supporting development of risk management plans.
- Conducting literature reviews and preparing research reports and scientific manuscripts.
- Staying abreast of the latest developments in the field of observational research and drug development.
- Promoting awareness, understanding and use of observational research methods.
- Supporting relationships with key leaders in OR and providing input at department meetings.
- Communicating 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 and 12 years of scientific experience
- Doctorate in Epidemiology or other subject with high observational research content.
- Experience in the design, execution and analysis of observation research studies within Pharmaceutical and/or Public Health settings.
- Experience in research to support drug development.
- Experience in observational research project planning and management.
- Experience communicating observational research information.
- Experience working in multi-disciplinary teams.
- Record of publications in observational research and/or clinical journals.
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.
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.