R&D Oncology Clinical Scientist, Specialist Full-time

Job Opportunity In Oncology Clinical Science

Oncology Clinical Science (OCS) is working in collaboration with various departments to develop groundbreaking new drugs for cancer treatment worldwide. In the oncology area, which is one of the company's top priorities, we aim to foster the growth of human resources through various experiences in contributing to development projects, acquiring specialized knowledge, enhancing science level and communication skills, and strengthening logical thinking abilities.

Our vision as the OCS department is to create new value by combining various wisdom and experiences as the OCS One team and to become a key contributor to the oncology development team for stakeholders. It is a very rewarding role that plays an important part in the success of clinical trials, and we have a supportive environment where employees can easily consult and cooperate with each other. We are looking forward to your active challenge.

As a key member of the clinical trial team, you will work in close coordination with the development responsibility (JCD) and other development-related departments (including the US headquarters) to execute clinical trials and take part in some of the tasks related to the consultation and approval application with the authorities.

Your responsibilities will include:

• Assisting in the formulation of the development strategy (inputting the Japanese clinical trial plan into the early and late development plan)
• Supporting the formulation and documentation of regulatory consultations based on the development strategy, and creating responses to inquiries
• Drafting and translating the clinical trial plan, including local trials (from trial outline) and global trials (mainly translation): explanation and negotiation with US headquarters or overseas vendors
• Creating informed consent documents (company prospectus)
• Supporting and reviewing documents related to the clinical trial plan (case report forms, related procedures, etc.)
• Creating attachments for the clinical trial notification (CTN) and responding to inquiries from PMDA
• Verifying the eligibility of cases, monitoring clinical trial data for medical issues, and responding to serious adverse events (SAE)
• Creating the overall clinical trial report and approval application materials (CTD) clinical part (in collaboration with medical writers) and reviewing them
• Creating responses to inquiries after approval and compliance investigation responses
• Supporting academic presentations, paper writing, and related activities

Required (desired) qualifications:

• Experience in clinical development of pharmaceuticals (oncology experience is desirable)
• Experience in creating clinical trial-related documents (preferably experience in creating clinical trial plans)
• Communication skills for close collaboration with related departments (domestic and abroad) and external specialists
• English proficiency (TOEIC score of 730 or above is recommended)

Job Posting End Date: 05/31/2025