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Medical Advisor (Solid Tumor)

Amgen

Career Category Medical Affairs Job Description Job purpose Lead and develop product medical strategy and plan based on product strategy. Key member to develop product strategy and local commercial team with brand team. Provide Japan position on global/region disease and product related programs.

Provide medical affair consideration on portfolio evaluation and discussion. ​ Lead evidence generation and publication plan and execution.

Key responsibility Partners with the brand team in the development and execution of the Local product(s) lifecycle management plan​ Leading and developing the Local Medical strategy and Medical activities for the product(s) in accordance to internal and external regulations​ TA and/or product specific Medical training ​ Ensuring consistency of Medical content and scientific messages across various tools and materials​ Visits selected KOL’s and study groups for strategic discussions and protocol development​ Develops study protocols for Local Amgen sponsored studies (AST); supports and executes Local study protocol preparation, filing, review and approval in line with Amgen processes and policies​ Works with GSO to ensure preparation, implementation and completion of AST’s Supports GSO in participation and completion of global/region studies in the country​ Reviews Local ISS proposals prior to approval and ensures appropriate Local/region/global committee review, if applicable​ Provides input into site selection for AST’s ​ Overseas in-sourced/outsourced Medical programs and logistics​ Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels​ Provides Medical expertise for pipeline products​ Provides Medical expertise for Health Economy and reimbursement requests Develops manuscripts and publication materials Plans and delivers medical education programs and scientific events ​ Basic Qualifications Selection Criteria (minimum Qualifications) Master’s degree Minimum of 3 years in pharmaceutical industry, or proven industry collaboration in academia ​ Experience in Medical Affairs or Clinical Development​ Experience with clinical study management and conduct​ Knowledge of commercialization and business practices ​Fluent in Japanese and English Preferred Qualifications Preferred Requirements MD, PharmD or PhD is required l Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs​ l Work experience in oncology area, especially in solid tumour ​ l Network of customer contacts in therapeutic area​ l Finance and budgeting experience​ Competencies Medical and scientific expertise​ Fluency in English, both oral and written communications​ Strong communication and presentation skills​ Continuously expanding medical and scientific knowledge as well as market knowledge​ Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, KOL management)​ Strong customer orientation; science-based ​ Ability to work in a cross-functional team (e.g., Commercial, Research & Development, Regulatory, Safety, etc.)​ Role model for others in line with Amgen Values​ Demonstrates leadersh .