(Senior) Medical Advisor (I&I)

The Senior Medical Advisor (I&I) at Amgen in Tokyo leads medical strategy and planning aligned with the product plan. As a key member of the brand team, you will collaborate with local commercial colleagues to shape product strategy, provide Japan-specific input on global and regional disease and product programs, contribute medical affairs input to portfolio evaluation, and lead the planning and execution of evidence generation, publications, and medical events.

Responsibilities

• Partner with the brand team to develop and execute the Local product lifecycle management plan.
• Lead and develop the Local Medical strategy and medical activities for the products in accordance with internal and external regulations.
• Provide therapeutic area and product-specific medical training.
• Ensure consistency of medical content and scientific messages across tools and materials.
• Visit selected KOLs and study groups for strategic discussions and protocol development.
• Develop study protocols for Local Amgen-sponsored studies (AST); support and execute local study protocol preparation, filing, review, and approval in line with Amgen processes and policies.
• Work with Global Study Operations to ensure preparation, implementation, and completion of ASTs.
• Support GSO in participation and completion of global/region studies in the country, including input on site selection.
• Review Local ISS proposals prior to approval and ensure appropriate local/region/global committee reviews where applicable.
• Oversee in-sourced and outsourced medical programs and logistics.
• Participate in or conduct Local Advisory Board Meetings, Investigator Meetings, and Expert Panels.
• Provide medical expertise for pipeline products as well as for health economics and reimbursement requests.

Requirements

• Basic qualifications: Master’s degree in life science or a relevant area, or equivalent education history; minimum of 2 years’ experience in the pharmaceutical industry or proven industry collaboration in academia; experience in developing and executing medical strategy for pre-launch products; 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 qualifications: MD, PharmD, or PhD strongly preferred; knowledge of pharmaceutical product development, lifecycle and commercialization processes, with advanced understanding of Clinical Operations, Commercial, Regulatory, and Medical Affairs; therapeutic area knowledge and experience preferred; established network of customer contacts in the therapeutic area; finance and budgeting experience; ability to perform office-based work and manage projects.
• Competencies: Medical/scientific expertise with business acumen; strong communications and presentation skills; fluency in English (oral and written); strong cross-functional collaboration skills with teams such as Commercial, Clinical Development, Regulatory, Safety, HE, and EU teams; demonstrated leadership, customer orientation, and science-based approach; ongoing expansion of medical, scientific, and market knowledge plus strong clinical research knowledge (study design, evaluation, medical writing, expert panels, symposium/workshop management, KOL management).