Description
Job purpose
+ 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.
Key responsibility
+ 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.
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 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
+ 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.
Competencies
+ Medical/scientific expertise, and business acumen with strategic thinking.
+ 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, external expert engagement.)
+ Strong customer orientation; science-based
+ Ability to work in a cross-functional team (e.g., 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.
+ Role model for others in line with Amgen Values
Demonstrates leadership skills
