R&D Oncology Clinical Science, Clinical Research Sr. Scientist Full-time

Clinical Development Project Manager

Oncology Clinical Science (OCS) is working on groundbreaking new drugs for cancer treatment worldwide in collaboration with various departments. In the oncology area, one of the company's top priorities, we aim to develop new drugs through development projects and provide various experiences to enhance expertise, improve communication skills, and strengthen logical thinking. Our vision for the OCS department is to create new value as an OCS team by combining various wisdom and experiences, and to contribute to the oncology development team as a key player for stakeholders. It is a very rewarding role that plays an important part in the success of clinical trials, and we have a comfortable environment where employees can easily consult and cooperate with each other. We are looking forward to your active challenge.

Expected Role

Coordinate with the development department (including US headquarters) as a key member of the clinical trial team to conduct clinical trials and participate in some of the tasks related to the consultation and approval application with the authorities.

Job Responsibilities

• Assist in formulating the development strategy (inputting the Japanese clinical trial plan into the early and late development plan)
• Support the formulation and creation of consultation documents based on the development strategy, and the creation of responses to inquiries
• Draft and translate the clinical trial implementation plan
• Local trial (drafting from the trial outline)
• Global trial (mainly translation): explanation and negotiation with US headquarters and overseas vendors
• Creation of informed consent documents (company proposal)
• Support and review of documents related to the clinical trial implementation plan (case report, related procedure manuals, etc.)
• Creation of attachment documents for the clinical trial notification (CTN) and response to inquiries from PMDA
• Confirmation of case eligibility, medical monitoring of clinical trial data, and response to serious adverse events (SAE)
• Creation and review of the clinical summary report and approval application materials (CTD) clinical part (in collaboration with medical writers) and response to inquiries after approval
• Support for academic presentations, paper writing, and related activities

Required Qualifications (Desired Qualifications)

• Experience in clinical development of pharmaceuticals (3 years or more oncology experience is preferable)
• Experience in creating clinical trial implementation plans
• Communication skills for close collaboration with internal (domestic and overseas) related departments and external specialists
• English proficiency (TOEIC score of 730 or higher is desirable)

Regular

Hybrid

05/31/2025