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About the Role

Lead and develop product medical strategy and plan based on product strategy for assigned product(s), including pipeline or pre-launch product(s). Act as a key Medical member in the cross-functional product team to develop and execute product strategy with cross-functional members, as well as Global/Regional Medical teams. 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.

Responsibilities

Partners with the brand team in the development and execution of the Local product(s) medical strategy and launch readiness 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
Engages external experts and stakeholders for scientific discussions, insight generation.
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
Oversees in-sourced/out-sourced medical programs and logistics , including vendor and timeline management.
Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
Provides Medical expertise for Health Economy and reimbursement requests
Proactively prioritizes and drives medical activities in alignment with cross-functional stakeholders in a complex and evolving environment.

Requirements

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 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, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs
Therapeutic area knowledge and experience is preferable
Scientific network with external experts in therapeutic area, or ability to build such network.
Experience in pre-launch planning, launch readiness, or pipeline product strategy is preferred.
Finance and budgeting experience
Project management skills.

Skills

Medical/scientific expertise
Business acumen
Strategic thinking
Fluency in English, both oral and written communications
Strong communication and presentation skills
Continuously expanding medical and scientific knowledge
Market knowledge
Strong clinical research knowledge (study design, study evaluation, medical writing skills, expert panel conduct, symposium and workshop management, external expert engagement.)
Strong customer orientation; science-based
Ability to work in a cross-functional team (e.g., Clinical Operations, Commercial, Clin Development, Global/Regional teams, Value & Access, Regulatory, Safety, etc.)
Ability to work proactively, set priorities, and drive execution in collaboration with relevant stakeholders.
Leadership skills

Experience Level

Minimum of 2 years in pharmaceutical industry

Education Level

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