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Amgen

Makes biotech medicines for serious illnesses

Medical Advisor - Solid Tumor

Biology & BiotechPosted on Nov 9
Full-timeTokyo, JapanNo salary listed

About the Job

Requirements

  • A Master's degree is required.
  • A minimum of 3 years of experience in the pharmaceutical industry, or proven industry collaboration in academia, is required.
  • Experience in Medical Affairs or Clinical Development is required.
  • Experience with clinical study management and conduct is required.
  • Knowledge of commercialization and business practices is required.
  • Fluency in Japanese and English is required.

Responsibilities

  • Lead and develop product medical strategy and plans based on product strategy.
  • Serve as a key member in developing product strategy and working with the local commercial team and brand team.
  • Provide Japan's position on global and regional disease- and product-related programs.
  • Provide medical affairs input to portfolio evaluation and discussion.
  • Lead evidence generation and publication planning and execution.
  • Partner with the brand team to develop and execute local product lifecycle management plans.
  • Lead and develop local medical strategy and medical activities for products in accordance with internal and external regulations.
  • Provide therapeutic-area and/or product-specific medical training.
  • Ensure consistency of medical content and scientific messages across tools and materials.
  • Visit selected key opinion leaders and study groups for strategic discussions and protocol development.
  • Develop study protocols for local Amgen-sponsored studies and support and execute local study protocol preparation, filing, review, and approval in line with company processes and policies.
  • Work with Global Study Operations to ensure preparation, implementation, and completion of Amgen-sponsored trials.
  • Support Global Study Operations in participating in and completing global and regional studies in Japan.
  • Review local investigator-sponsored study proposals before approval and ensure appropriate local, regional, or global committee review when applicable.
  • Provide input into site selection for Amgen-sponsored trials.
  • Oversee insourced and outsourced medical programs and logistics.
  • Participate in or conduct local advisory board meetings, investigator meetings, and expert panels.
  • Provide medical expertise for pipeline products.
  • Provide medical expertise for health economics and reimbursement requests.
  • Develop manuscripts and publication materials.
  • Plan and deliver medical education programs and scientific events.

Desired Qualifications

  • Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, with advanced understanding of other functions including Clinical Operations, Commercial, Regulatory, and Medical Affairs.
  • Work experience in oncology, especially solid tumors.
  • A network of customer contacts in the therapeutic area.
  • Finance and budgeting experience.
  • Medical and scientific expertise.
  • Fluency in written and spoken English.
  • Strong clinical research knowledge, including study design, study evaluation, medical writing, expert panel conduct, symposium and workshop management, and key opinion leader management.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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