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

Location: Tokyo, Japan; hybrid

Company

hirify.global develops medicines and vaccines and conducts clinical development programs worldwide.

What you will do

• Provide medical and scientific oversight for clinical trials, primarily in Japan and the Asia-Pacific region.
• Contribute medical input to protocol design, clinical development plans, country feasibility, monitoring guidelines, and clinical review materials.
• Review individual and cumulative safety data, support risk assessment and mitigation, and provide medical context for adverse event and serious adverse event reports.
• Interpret clinical trial efficacy and safety data and contribute to top-line reports, clinical study reports, regulatory documents, abstracts, posters, and publications.
• Support study teams with vendor selection, investigator and study-team training, data quality, protocol compliance, issue resolution, audits, and inspection readiness.
• Interact with the PMDA, other regulatory authorities, Data Monitoring Committees, steering committees, investigators, and key opinion leaders.

Requirements

• Medical degree (M.D. or equivalent).
• At least one year of independent medical prescribing experience after the intern or house officer year.
• Ability to critically evaluate medical and scientific information and understand the design, development, and execution of clinical programs and studies.
• Excellent written and oral communication in English and Japanese.
• Ability to adapt to a fast-paced and changing environment.

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

• Hybrid work arrangement.
• Collaboration with international clinical development teams.
• Work involving regulatory approval programs in Japan and other Asian countries.