Amgen Observational Research Manager (Epidemiologist) in Tokyo, Japan

Purpose

  • Leads and executes specific observational research projects within a product team or therapeutic area

  • Contribute to observational research throughout the product commercialization process

Responsible for:

  • Conducting research to the highest standards of the profession

  • Aligning research with the product team's medical strategies

  • Participating in initiatives to improve processes/capabilities in evidence generation activities

Key Activities and Skills

Conduct of Amgen-sponsored observational studies:

  • Develops study proposals and protocols in high quality

  • Conducts high-quality observational research to support medical strategy

  • Develops scientific manuscripts and presentations for a variety of audiences

  • Supports post-marketing surveillance using existing databases

  • Addresses regulatory and compliance requirements related to observational research

  • Manages vendors with controlling contract, budget, and timeline

  • Coordinates data purchase agreements

Facilitation of observational research and use of real-world evidenc e :

  • Contributes to medical strategy with observational research expertise

  • Contributes to real-world data analyses to support various business needs

  • Establishes processes for local observational research operations as needed

  • Collaborates with relevant internal/external stakeholders

  • Sets annual product-specific and personal goals

  • Takes leadership in a matrix environment

  • Promotes observational research awareness

  • Stays abreast of the latest developments in the field of observational research and drug development to contributes to the field

Basic Qualifications

  • Masters degree in Epidemiology or other subject with high observational research content or MD with observational research experience

  • Three (3) or more years of clinical research and/or observational research experience in industry or academic settings

  • Record of publications in clinical and/or observational research

Preferred Qualifications

  • Doctorate in Epidemiology or other subject with high observational research content

  • Experience in research to support drug development and/or pharmacovigilance in industry

Required Knowledge

  • Observational research methodology and applications

  • Programming in SAS or other software (e.g. STATA)

  • Literature search

  • Drug development processes and operations

  • Relevant regulations and guidelines

  • Written and oral scientific communications skills

  • Project management/project planning

  • Native level Japanese and Business English (oral and written)