Amgen is looking to solve business and technical problems related to drug development and regulatory submissions by leveraging observational research to investigate post-marketing safety and effectiveness, identify evidence needs, and support product development and commercialization strategies.
Requirements
- 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
Responsibilities
- Effectively lead, develop, and mentor a team of scientists
- Be the technical expert in a cross-functional team to: identify evidence needs; develop the RWE plan to support the product development and commercialization strategy; and develop, maintain and expand a portfolio of observational research activities to support these strategies
- Design and implement 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 as to 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 partners
- Track business and functional priorities and align resources against those priorities
Other
- 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
- At least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- Excellent verbal and writing communication and interpersonal skills
- Experience working in multi-disciplinary teams
- Sponsorship for this role is not guaranteed.
