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About the Role

Lead and develop product medical strategy and plan based on product strategy. Serve as a key member of the brand team to develop product strategy with the local commercial team. Provide Japan's position on global/region disease and product-related programs. Offer medical affairs considerations for portfolio evaluation and discussion. Lead the planning and execution of evidence generation, publications, and medical events.

Responsibilities

Partner with the brand team in the development and execution of the local product lifecycle management plan.
Lead and develop the local medical strategy and medical activities for the product(s) in accordance with internal and external regulations.
Provide TA and/or product-specific medical training.
Ensure consistency of medical content and scientific messages across various 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 (GSO) to ensure preparation, implementation, and completion of ASTs.
Support GSO in participation and completion of global/region studies in the country, including providing input into site selection.
Review Local ISS proposals prior to approval and ensure appropriate local/region/global committee review, if applicable.
Oversee in-sourced/out-sourced medical programs and logistics.
Participate in/conduct Local Advisory Board Meetings, Investigator Meetings, and/or Expert Panels.
Provide medical expertise for pipeline products.
Provide medical expertise for Health Economy and reimbursement requests.

Requirements

Master’s degree in life-science or relevant area, or equivalent education history.
Minimum of 2 years 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.
MD, PharmD or PhD is strongly preferred.
Knowledge of pharmaceutical product development, product lifecycle, and commercialization process with advanced understanding of other functions, including 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 management.
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.

Skills

Medical strategy development
Product strategy
Brand team collaboration
Global/region program input
Portfolio evaluation
Evidence generation
Publications planning
Medical event planning
Lifecycle management
Medical training
Medical content consistency
Scientific messaging
KOL engagement
Study protocol development
Clinical study management
Study Operations collaboration
ISS proposal review
Medical program oversight
Advisory Board participation
Investigator Meeting participation
Expert Panel participation
Pipeline product expertise
Health Economy expertise
Reimbursement expertise
Pharmaceutical industry experience
Clinical Development experience
Commercialization knowledge
Business practices knowledge
Japanese fluency
English fluency
Pharmaceutical product development knowledge
Product lifecycle knowledge
Commercialization process knowledge
Cross-functional team collaboration
Leadership skills
Communication skills
Presentation skills
Clinical research knowledge
Study design
Study evaluation
Medical writing
Symposium management
Workshop management
KOL management
Customer orientation
Finance experience
Budgeting experience
Project management

Experience Level

Minimum of 2 years in pharmaceutical industry
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

Education Level

Master’s degree in life-science or relevant area
MD, PharmD or PhD