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東京都の臨床開発・薬事の求人240件応募資格・募集要項・仕事内容を見る
Oncology Clinical Scientist
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
The Oncology Clinical Scientist will drive the development and execution of the Japan Clinical Development Plan, aligned with global asset and program strategies. The role supports clinical studies in Japan from protocol development through PMDA interactions and leads regulatory submissions for approval in Japan. Responsibilities also include clinical oversight of trials, clinical document contributions, and participation in global study activities when assigned as a Global Study Responsible Scientist.
この求人に応募
応募資格
必須
- Bachelor's degree or above in biology, pharmacology or a related scientific field; PhD preferred
- Minimum 5 years' 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 global (English-speaking) matrix teams
- Sound scientific judgement and strong communication skills
歓迎
- Clinical Evaluations
- Coaching
- Critical Thinking
- Drug Discovery Development
- Entrepreneurship
- Good Clinical Practice (GCP)
- Leadership
- Medicines and Device Development and Regulation
- Organizing
- Regulatory Affairs Management
- Relationship Building
- Research Documents
- Safety-Oriented
- Scientific Research
- Standard Scientific Processes and Procedures
- Strategic Change
- Study Management
募集要項最終確認 11/8
- 職種
- 臨床開発・薬事
- 雇用形態
- 記載なし
- 役職
- Oncology Clinical Scientist (Manager)
- 給与
- 記載なし
- 勤務地
- Chiyoda, Tokyo, Japan
- 働き方
- 記載なし
- 経験年数
- 5年以上
- 学歴
- 大学卒業以上
- 掲載日
- 2026/11/03 09:50（7日前）
- 最終確認
- 2026/11/08 21:50（2日前）
仕事内容
募集内容
- We are searching for the best talent for an Oncology Clinical Scientist (Manager) to join our Clinical Development team in Japan.
Purpose
- Help bring innovative oncology medicines to patients in Japan. In this role, you will drive the development and execution of the Japan Clinical Development Plan, working closely with the Global Clinical Development Team to align it with global asset and program strategies. Through clinical science support for studies conducted in Japan, from protocol development through to PMDA interactions, you will help deliver high-quality, compliant and timely clinical development outcomes, with the opportunity to contribute to global studies as a Study Responsible Scientist. Based on the clinical trial results obtained, you will also lead the regulatory submission for approval in Japan.
You will be responsible for:
- Contributing to Japan clinical development strategies aligned to global asset and program plans, and drafting Japan local protocols, amendments and planning documents
- Leading local companion diagnostic (CDx) development with support from the global CDx team
- Providing clinical oversight of trials in Japan, partnering with Clinical Operations on feasibility, investigator interactions, site training, enrolment and protocol interpretation
- Supporting and performing eligibility and medical review, and interpreting study results with the broader study team to inform trial conduct, development strategy and regulatory decisions
- Contributing to key clinical documents, including clinical study reports, protocols, informed consent documents and CRFs, through section authorship and quality control
- Preparing clinical sections of Japan regulatory submissions and responses to PMDA inquiries, and participating in PMDA consultation meetings
- Contributing to global study activities when assigned as a Global Study Responsible Scientist (SRS)
Key interfaces
- Global Clinical Development Team (CDT) and Clinical Operations (GCO)
- Biostatistics, data management, safety/pharmacovigilance, regulatory affairs, medical writing, quality, translational sciences and medical affairs
- PMDA
- Investigators, key opinion leaders, external advisors and vendors
Measures of success
- High-quality, compliant and timely delivery of Japan clinical studies and Japan components of global trials
- Scientifically accurate, consistent and compliant clinical documents and regulatory submissions
- Timely identification and escalation of clinical issues
- Strong cross-functional alignment across the global and local matrix
Accountability principles
- Delivers assigned clinical development activities with guidance and growing independence
- Performs regulatory activities with appropriate supervision, ensuring scientific accuracy and compliance
- Identifies and escalates clinical issues appropriately, in line with standard clinical development practices
この求人は、ジョンソン・エンド・ジョンソン株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
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募集元の採用ページから応募できます
応募はジョンソン・エンド・ジョンソン株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
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