A global pharmaceutical organization is seeking a Clinical Development Scientific Lead to provide clinical, medical, and scientific leadership for vaccine development programs at country, regional, and global levels.
As the clinical leader of the (Extended) Clinical Team, the Clinical Development Scientific Lead represents Clinical Development within Global Project Teams and is accountable for the design, execution, and scientific integrity of the Clinical Development Plan (CDP), as well as regulatory interactions and ethical oversight of clinical trials.
Lead and own the Clinical Development Plan and clinical strategy for assigned vaccine programs
Act as the clinical representative in Global Project Teams
Lead regulatory interactions and clinical content of submissions (e.g. CTD, briefing packages)
Provide medical monitoring oversight and ensure subject safety and GCP compliance
Lead protocol development, study result interpretation, and clinical documentation
Engage with regulatory authorities, public health agencies, investigators, and advisory boards
Ensure ethical integrity and scientific rigor of clinical trials
Communicate clinical data and strategy to senior management and external stakeholders
Support epidemiology studies and contribute to competitive intelligence activities
Education & Experience
MD, PhD, or PharmD required (MD strongly preferred)
Experience in immunology, infectious diseases, pediatrics, or internal medicine preferred
Pharmaceutical industry or equivalent academic clinical research experience required
Languages
Full professional proficiency in English and Japanese
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