Medical Advisor (Solid Tumor)

Career Category

Job Description

Job purpose

• Lead and develop product medical strategy and plan based on product strategy.

• Key member to develop product strategy and local commercial team with brand team.

• Provide Japan position on global/region disease and product related programs.

• Provide medical affair consideration on portfolio evaluation and discussion.

• Lead evidence generation and publication plan and execution.

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 GSO to ensure preparation, implementation and completion of AST’s

• Supports GSO in participation and completion of global/region studies in the country

• Reviews Local ISS proposals prior to approval and ensures appropriate Local/region/global committee review, if applicable

• Provides input into site selection for AST’s

• Overseas in-sourced/outsourced 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

• Develops manuscripts and publication materials

• Plans and delivers medical education programs and scientific events

Basic Qualifications Selection Criteria (minimum Qualifications)

• Master’s degree

• Minimum of 3 years in pharmaceutical industry, or proven industry collaboration in academia

• Experience in Medical Affairs 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 required

l 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

l Work experience in oncology area, especially in solid tumour

l Network of customer contacts in therapeutic area

l Finance and budgeting experience

Competencies

• Medical and scientific expertise

• 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, Research & Development, Regulatory, Safety, etc.)

• Role model for others in line with Amgen Values

Demonstrates leadersh