Job Description

Career Category

Medical Affairs

Job purpose

• Lead and develop product medical strategy and plan based on product strategy.
• Key member in the brand team to develop product strategy with and local commercial team.
• Provide Japan position on global/region disease and product related programs.
• Provide medical affair consideration on portfolio evaluation and discussion.
• Lead the planning and execution of evidence generations, publications and medical events.

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 Global Study Operations (GSO) to ensure preparation, implementation and completion of ASTs
• Supports GSO in participation and completion of global/region studies in the country, including provision of input into site selection
• Reviews Local ISS proposals prior to approval and ensures appropriate
• Local/region/global committee review, if applicable
• Oversees in-sourced/out-sourced 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

Basic Qualifications Selection Criteria (minimum Qualifications)

• Master’s degree in life-science or relevant area, equivalent education history
• Minimum of 2 years in 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 Preferred Requirements

• MD, PharmD or PhD is strongly preferred
• 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
• Therapeutic area knowledge and experience is preferable
• Network of customer contacts in therapeutic area
• Finance and budgeting experience
• Capability of office works and project managements

Competencies

• Medical/scientific expertise, and business acumen
• 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, Clin Development, EU teams, HE, Regulatory, Safety, etc.)
• Role model for others in line with Amgen Values
• Demonstrates leadership skills