Observational Research Senior Manager (Rare Disease)

What you will do

In this vital role you will be responsible for research activities on the Rare Disease therapeutic area team. The CfOR Senior Manager is recognized as a strong scientific contributor and a first or contributing author for papers in peer-reviewed journals, abstracts for scientific congresses and internal reports that enhance the company's mission.

With a constantly increasing demand for information from regulatory and reimbursement agencies, Observational research (OR) has become a critical area in drug development and commercialization. Amgen's Center for Observational Research (CfOR) partners with internal and external teams to generate real world evidence for multiple partners across the product lifecycle. The CfOR contributes evidence regarding the frequency and distribution of disease or the clinical burden of disease, the natural history or clinical course of disease, the design of clinical trials, cost and utilization patterns and the safety and effectiveness of interventions.

Responsibilities

• Designing and executing studies to support evidence generation such as identifying appropriate patient populations, assessing disease burden and resource utilization, obtaining product registrations and label-expansions, meeting post-marketing requirements/commitments and product differentiation.
• Finding opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development.
• Influencing cross-functional partners in the utilization and timing of non-interventional research to answer high-priority strategic business questions.
• Demonstrating real-world data and CfOR analytic approaches to inform high-value business decisions for multiple partners.
• Tracking business and functional priorities and aligning resources for those priorities.
• Contributing to the mission of the CfOR including progressing innovative epidemiological methods and analytical capabilities to support the CfOR's leadership role within Amgen and the industry.

Basic Qualifications

• Doctorate degree and 2 years of related research and scientific experience or
• Master's degree and 6 years of related research and scientific experience or
• Bachelor's degree and 8 years of related research and scientific experience or
• Associate's degree and 10 years of related research and scientific experience or
• High School diploma / GED and 12 years of related research and scientific experience

Preferred Qualifications

• Doctorate in Epidemiology or other subject with high observational research content.
• Experience in the design, implementation and analysis of observation research studies within Pharmaceutical and/or Public Health settings.
• 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 communication, presentation and interpersonal skills.
• Demonstrated experience working with and leading multi-disciplinary teams.