Oncology Clinical Scientist (Manager)

About the role

Johnson & Johnson is looking for an Oncology Clinical Scientist (Manager) to join its Clinical Development team in Japan. The purpose is to help bring innovative oncology medicines to patients in Japan by driving the Japan Clinical Development Plan, working closely with the Global Clinical Development Team. The role covers clinical science support for studies in Japan, from protocol development through to PMDA interactions, and includes leading regulatory submission for approval in Japan.

Key responsibilities

• Contribute to Japan clinical development strategies aligned with global asset and program plans, and draft local protocols, amendments and planning documents
• Lead local companion diagnostic (CDx) development with support from the global CDx team
• Provide clinical oversight of trials in Japan, partnering with Clinical Operations on feasibility, investigator interactions, site training, enrolment and protocol interpretation
• Support and perform eligibility and medical review, and interpret study results with the study team
• Contribute to clinical study reports, protocols, informed consent documents and CRFs through section authorship and quality control
• Prepare clinical sections of Japan regulatory submissions and responses to PMDA inquiries, and take part in PMDA consultation meetings
• Contribute to global study activities as a Global Study Responsible Scientist (SRS)

Required profile

• Bachelor's degree or above in biology, pharmacology or a related scientific field; PhD preferred
• Minimum 5 years of oncology clinical research experience in pharmaceutical clinical development, or equivalent experience in academic institutions
• Solid understanding of ICH-GCP and the Japan regulatory environment
• Ability to work effectively in both Japanese and English-speaking global teams
• Sound scientific judgement and strong communication skills