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About the Role
The Japan Clinical Lead for Oncology will act as a key member of the global clinical team, providing local insights and clinical expertise to shape global development strategies. This role involves overseeing the execution of clinical studies in Japan, serving as a Study Responsible Physician or Scientist, and mentoring junior team members to ensure high-quality, integrated clinical research.
Responsibilities
- Provide clinical leadership in the Japan project team to evaluate and recommend clinical inputs for global development strategies.
- Collaborate with global compound clinical leads and medical heads to ensure strategic alignment and flawless study execution.
- Lead clinical interactions with PMDA/MHLW and oversee the development of clinical regulatory documentation.
- Mentor and supervise junior clinical project scientists and physicians.
- Represent the clinical program to investigators, key opinion leaders, and business partners.
- Support the development and compilation of JNDA and manage responses to PMDA inquiries.
- Ensure comprehensive medical monitoring and timely resolution of site issues and safety queries.
- Review clinical study data including eligibility, efficacy, safety, and protocol deviations.
- Collaborate on study design elements and track recruitment progress to address enrollment impediments.
- Support medical affairs with evidence generation plans for value maximization in Japan.
Requirements
- B.S. or above in biology, pharmacology, or related scientific specialties.
- Minimum of 5 years of clinical research experience in the pharmaceutical industry or academia.
- Knowledge of Good Clinical Practices and regulatory requirements for oncology clinical trials.
- Fluency in written and spoken English.
- Native-level proficiency in Japanese.
- Proficiency in Microsoft Excel and Word.
Skills
- Clinical Evaluations
- Corrective and Preventive Action (CAPA)
- Drug Discovery Development
- Entrepreneurship
- Good Clinical Practice (GCP)
- Leadership
- Medicines and Device Development and Regulation
- Presentation Design
- Regulatory Affairs Management
- Relationship Building
- Research Documents
- Safety-Oriented
- Scientific Research
- Strategic Change
- Study Management
- Tactical Planning
- Technical Credibility
Location
- Chiyoda, Tokyo, Japan
Work Type
- Hybrid
- Full-time
Experience Level
- Minimum 5 years of clinical research experience
Education Level
- B.S. or above in biology, pharmacology, or related scientific specialties
- PhD preferred
- M.D. holders may apply
About the Company
- Johnson & Johnson is a global healthcare company focused on preventing, treating, and curing complex diseases.
- The company operates through Innovative Medicine and MedTech sectors.
- Guided by Our Credo, the company prioritizes an inclusive work environment that respects diversity and individual merit.
Equal Opportunity
- Johnson & Johnson provides an inclusive work environment where each person is considered as an individual.