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18 часов назад

R&D Clinical Development Medical, Associate Director, Research and Development - Vaccines (Vaccines)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Japan
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
R&D Clinical Development Medical, Associate Director, Research and Development - Vaccines (Vaccines): Providing medical and scientific oversight for worldwide vaccine clinical trials, with a primary focus on Japan and the Asia-Pacific region, and contributing to development strategies for regulatory approval. Focus on designing protocols, monitoring patient safety, interpreting efficacy and safety data, supporting PMDA interactions, and preparing regulatory documents.

Location: Tokyo, Japan; hybrid work arrangement

Company

hirify.global develops medicines and vaccines through global research and clinical development programs.

What you will do

  • Provide medical and scientific oversight for worldwide vaccine clinical trials, primarily in Japan and the Asia-Pacific region.
  • Contribute medical expertise to protocol design, clinical development plans, country feasibility, and regulatory strategy.
  • Advise study teams on risk assessment, mitigation planning, safety surveillance, adverse events, and patient safety.
  • Review and interpret clinical efficacy and safety data and contribute to top-line reports and clinical study reports.
  • Train study teams, investigators, and clinical research associates while supporting data quality, compliance, audits, and inspection readiness.
  • Support interactions with regulatory authorities, including PMDA, as well as key opinion leaders and principal investigators.

Requirements

  • Medical degree (M.D. or equivalent).
  • At least one year of independent medical prescribing experience after the internship or house officer year.
  • Ability to critically evaluate medical and scientific information and understand clinical program and study execution.
  • Excellent written and oral communication skills in English and Japanese.
  • Ability to adapt to a fast-paced and changing environment.
  • Hybrid work in Tokyo, Japan.

Nice to have

  • Work experience or knowledge of statistics.
  • Training or experience in infectious diseases or hospital infection control.
  • Experience with investigational clinical trials.
  • Flexibility to join frequent late-night or early-morning international teleconferences.
  • Ability to travel domestically or internationally when required.

Culture & Benefits

  • Collaboration with global, Japan, and Asia-Pacific development teams.
  • Opportunities to work with investigators, healthcare professionals, regulatory authorities, and scientific experts.
  • Occasional domestic and international travel.
  • Equal employment opportunity in accordance with applicable local legislation.

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