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We are currently hiring for an Observational Research Director to support the obesity franchise. The growing 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 industry-leading capabilities to generate generates 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.
Job Responsibility
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
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 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 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 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
Requirements
Doctorate degree and 4 years of scientific experience
Master's degree and 8 years of scientific experience
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
What we offer
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