About this role
Career Category Medical Affairs Job 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
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