Medical Advisor for Rare Disease (Manager level)

Posted:
8/26/2024, 3:10:29 PM

Location(s):
Tokyo, Japan

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
Medical, Clinical & Veterinary

Career Category

Scientific

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.
  • Implement various scientific programs in collaboration with internal stakeholders such as the Commercial or R&D

Key responsibility

  • Identifies, develops and maintains collaborative relationships with current and future OLs, scientific experts, cooperative study groups and study sites
  • 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 ​
  • Oversees in-sourced/outsourced Medical programs and logistics​
  • Participates in/conducts Local Advisory Board Meetings, Investigator Meetings and/or Expert Panels​
  • Provides Medical expertise for products​
  • Provides Medical expertise for Health Economy and reimbursement requests​

Basic Qualifications Selection Criteria (minimum Qualifications)

  • Master’s degree
  • 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 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 ​
  • Network of customer contacts in therapeutic area​
  • 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, Clinical Development, HE, Regulatory, Safety, etc.)​
  • Role model for others in line with Amgen Values​
  • Demonstrates leadership skills​

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