Observational Research Manager - Cardiovascular
About the role
In this vital role you will be working with multiple teams to generate real world evidence supporting a wide variety of business needs. The increasing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a key component of drug development and commercialization.
Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a product’s lifecycle. CfOR scientists partner with internal team members and industry experts to design, conduct, interpret and publish observational research that informs decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines.
CfOR studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, treatment cost and utilization patterns, and the safety and effectiveness of therapeutic interventions.
In this role you will have responsibilities for research activities on product-facing teams in the therapeutic area of cardiovascular disease. A CfOR Manager is recognized as a strong scientific contributor and is a first or contributing author for papers in peer-reviewed journals, abstracts for scientific congresses or for internal reports that enhance the company’s mission.
Responsibilities
- Manage descriptive epidemiologic studies to characterize the incidence/prevalence of disease in US, EU, Asia, and emerging market countries
- Manage research projects involving the analysis of multiple types of data including medical claims, electronic health records, and prospective observational cohort studies
- Provide safety research support across the life cycle of Amgen products, supports the development of risk management plans, and implements pharmacovigilance studies
- Conduct literature reviews and prepares research reports and scientific manuscripts
- Stay abreast of the latest developments in the field of observational research and drug development
- Promote awareness, understanding, and use of observational research methods
- Communicate scientific information to a variety of audiences
Requirements
- Doctorate degree
- Or Master's degree and 2 years of scientific experience
- Or Bachelor's Degree and 4 years of scientific experience
- Or Associate’s degree and 8 years of scientific experience
- Or High school diploma / GED & 10 years of scientific experience
Qualifications
- Doctorate in Epidemiology or other subject with high observational research content
- Experience in cardiovascular disease
- Experience in the design, execution, and analysis of observational research studies within Pharmaceutical or Public Health setting
- Experience in research to support drug development
- Experience working with secondary data systems, including administrative claims, EMR, and registries
- Experience in observational research project planning and management
- Excellent verbal and writing communication and interpersonal skills
- Experience working in multi-disciplinary teams
- Outstanding study design and applied biostatistical methods to support a pragmatic, resourceful, proactive, self-motivated thinker with excellent judgement
- Experience communicating / translating real-world evidence for clinical impact
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible