18 часов назад
R&D Clinical Development Medical, Associate Director, Research and Development - Vaccines (Vaccines)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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