Career Category

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

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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