Career Category
Medical Affairs
Job Description
Career Category: Medical
Report to: CMAL
Job purpose
- Lead and develop product medical strategy and plan based on product strategy.
- Key member in the brand team to develop product strategy with and local commercial team.
- 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) 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 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
- Reviews Local ISS proposals prior to approval and ensures appropriate
- Local/region/global committee review, if applicable
- Oversees in-sourced/out-sourced medical programs and logistics
- Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels
- Provides Medical expertise for pipeline products
- Provides Medical expertise for Health Economy and reimbursement requests
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
- Network of customer contacts in therapeutic area
- Finance and budgeting experience
- Capability of office works and project managements
Competencies
- 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
.