Observational Research, Director (Obesity)

Amgen•Thousand Oaks, CA

9d•Remote

About The Position

Amgen's Center for Observational Research (CfOR) is a global organization with industry-leading capabilities to generate real-world evidence (RWE) that supports business needs across a product’s lifecycle. CfOR scientists partner with internal collaborators and industry experts to craft, conduct, interpret, and publish observational research that advises 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 the disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions. This role will lead a team of epidemiologists to conceptualize, design, conduct, analyze, interpret and publish observational research supporting drug development programs and regulatory submissions, investigating post-marketing safety and effectiveness.

Requirements

Doctorate degree and 4 years of scientific experience OR Master’s degree and 8 years of scientific experience OR Bachelor’s degree and 10 years of scientific experience
Doctorate in Epidemiology or other subject with high observational research content
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 in observational research project planning and management
Excellent verbal and writing communication and interpersonal skills
Experience working in multi-disciplinary teams

Responsibilities

Lead, develop, and mentor a team of scientists.
Serve as the technical expert in a cross-functional team to identify evidence needs, develop the RWE plan to support product development and commercialization strategy, and develop, maintain, and expand a portfolio of observational research activities.
Design and execute 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.
Find opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development.
Influence cross-functional team members regarding the appropriate use and timing of non-interventional research to answer high-priority strategic business questions.
Leverage real-world data and CfOR analytic approaches to inform high-value business decisions for multiple stakeholders.
Track business and functional priorities and align resources against those priorities.
Participate in initiatives to improve capabilities within CfOR and provide input into CfOR meetings.
Develop and maintain relationships with key leaders in observational research.