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.
+ Implement various scientific programs in collaboration with internal stakeholders such as the Commercial or R&D
**Key responsibility**
+ Identifies, develops and maintains collaborative relationships with current and future OLs, scientific experts, cooperative study groups and study sites
+ 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
+ Oversees in-sourced/outsourced Medical programs and logistics
+ Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
+ Provides Medical expertise for products
+ Provides Medical expertise for Health Economy and reimbursement requests
**Basic Qualifications Selection Criteria (minimum Qualifications)**
+ Master’s degree
+ Minimum of 2 years in pharmaceutical industry, or proven industry collaboration in academia
+ Experience in Medical Department or Clinical Development
+ Knowledge of commercialization and business practices
+ Fluent in Japanese and English
**Preferred Qualifications Preferred Requirements**
+ MD, PharmD or PhD is 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 (Bone)
+ Network of customer contacts in therapeutic area
+ 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, Clin Development, HE, Regulatory, Safety, etc.)
+ Role model for others in line with Amgen Values
+ Demonstrates leadership skills
