Career Category

Job Description

Purpose

• Guide the epidemiology research in partnership with local, regional, and global cross-functional teams for use in clinical drug development, regulatory decision-making, and improving patient outcomes
• Advance Amgen’s core capabilities to conduct observational research in Japan

Responsible for:

• Conducting observational research to the highest standards of the profession
• Aligning research with the product team’s strategies
• Leading initiatives to improve processes/capabilities in observational research/real-world evidence activities
• Leading the observational research team and coaching others to develop stronger change management skills and greater comfort with change
• Actively communicating the purpose, strategy and status of change efforts
• Considering future possibilities and scenarios that may affect the team/organization
• Creating strategies that leverage competitive advantages and emerging trends

Key Activities and Skills

Conduct of Company-Sponsored observational studies:

• Develop and execute observational research plan that align with development and medical strategy
• Develop scientific report and publications for a variety of audiences
• Address regulatory and compliance requirements related to observational research
• Oversee suppliers with controlling contact, budget, and timeline

Facilitation of observational research and use of real-world evidence:

• Contribute to development and medical strategy with observational research expertise
• Contribute to real-world data analysis to support various business needs
• Establish processes for local observational research operations as needed
• Collaborate with relevant internal/external stakeholders
• Take leadership in a matrix environment and promote observational research awareness
• Stay abreast of the latest developments in the field of observational research and drug development to contributes to the field

Development of the best team and delivers results:

• Ensure that all team members are motivated to work toward common goals and coach and mentor key talent
• Strategically build and grow the best team, achieve steady results, and communicate initiatives and results to local, regional, and global stakeholders

Basic Qualifications

• Doctorate degree or Master's degree and 5 years of scientific experience
• Experience in the design, execution, and analysis of observation research studies within the pharmaceutical or academic setting
• Two years of people management experience

Preferred Qualifications

• PhD in Epidemiology or other subject with high observational research content or MD with a Master’s degree in a subject with observational research content
• Record of publications in clinical and observational research
• Experience in observational research project planning and management

Required Knowledge

• Observational research methodology and applications
• Programming in SAS or other statistical software
• Literature search
• Drug development processes and operations
• Relevant regulations and guidelines
• Written and oral scientific communications skills
• Business level Japanese and English (both oral and written)