Medical Advisor (BONE)

Overview

The Medical Advisor (BONE) at Amgen, based in Tokyo, Japan, leads and develops the product medical strategy and plan aligned with the overall product strategy. As a key member of the brand team, you will partner with the local commercial team to provide Japan-specific input on global/region disease and product programs and contribute medical affairs perspectives on portfolio evaluation and discussion. You will plan and execute evidence generation, publications, and medical events.

Responsibilities

• Partner with the brand team to develop and execute the Local product lifecycle management plan and local medical strategy for the product(s) in accordance with internal and external regulations.
• Lead medical activities and training related to the product, ensuring consistency of medical content and scientific messages across tools and materials.
• Engage with selected KOLs and study groups for strategic discussions and protocol development; develop study protocols for local Amgen-sponsored studies (AST) and support or manage local protocol preparation, filing, and approvals in line with Amgen processes.
• Collaborate with Global Study Operations (GSO) to ensure preparation, implementation, and completion of ASTs; support GSO participation in global/region studies in the country and provide input on site selection.
• Review Local ISS proposals prior to approval and coordinate appropriate local/regional/global committee review as applicable.
• Oversee in-sourced/out-sourced medical programs and logistics; participate in or conduct Local Advisory Board Meetings, Investigator Meetings, and/or Expert Panels.
• Provide medical expertise for pipeline products and for Health Economics and reimbursement requests.

Requirements

• Master’s degree in life sciences or a relevant field; equivalent education history.
• Minimum of 2 years in the pharmaceutical industry or demonstrated industry collaboration in academia; experience in Medical Department or Clinical Development.
• Experience with clinical study management and conduct; knowledge of commercialization and business practices.
• Fluent in Japanese and English.
• Preferred: MD, PharmD, or PhD; knowledge of pharmaceutical product development, lifecycle, and commercialization with understanding of Clinical Operations, Commercial, Regulatory, and Medical Affairs; therapeutic area knowledge and a network of contacts in the therapeutic area; finance and budgeting experience; strong office and project management capabilities.