R&D Oncology Clinical Science, Clinical Research Sr. Scientist
Core
Execute clinical trials for oncology new drug development in Japan, collaborating with global teams to support regulatory submissions and strategic planning.
Role type
Senior Individual Contributor Clinical Scientist (Oncology)
Builds
Clinical trial protocols, regulatory submission documents (CTD), and medical monitoring reports for oncology therapies.
Domain
Oncology, Clinical Development, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Trial Planning, Protocol Development, Medical Writing, Regulatory Submissions, Medical Monitoring, Ethical Compliance, ICH GCP Guidelines, Data Analysis, Therapeutic Knowledge, Scientific Publications
Preferred skills
Oncology therapeutic area experience, Global trial translation experience, PMPA/CTN submission experience
Responsibilities
Assist in developing clinical development strategies and inputting Japanese trial plans into global protocols; Create and translate clinical trial protocols and informed consent forms; Conduct medical monitoring of trial data and manage serious adverse event (SAE) reporting; Prepare regulatory submission documents (CTD) and respond to authority queries; Review case report forms and related trial documentation; Present at conferences and support scientific publications.
Seniority
Senior, hands-on IC
