Senior Medical Manager, Clinical Science Oncology (Innovative Medicine)

Location: Chiyoda, Tokyo, Japan; hybrid work with office attendance 3 days per week

Company

Johnson & Johnson Innovative Medicine develops medicines and clinical solutions for complex diseases, including oncology, immunology, neuroscience, and cardiovascular and metabolic conditions.

What you will do

• Lead Japan clinical input into global oncology clinical development strategies within a matrix team.
• Oversee the execution and quality of early- and late-development oncology clinical studies in Japan.
• Lead clinical interactions with PMDA and MHLW and support regulatory document development, JNDA submissions, and responses to regulatory questions.
• Support study monitoring, eligibility and safety reviews, protocol implementation, data quality, recruitment tracking, and medical query resolution.
• Collaborate with Clinical Operations, Data Management, Statistics, Regulatory, Medical Writing, investigators, key opinion leaders, and business partners.
• Train, mentor, and supervise clinical project physicians and scientists across assigned studies.

Requirements

• Bachelor’s degree or above in biology, pharmacology, or a related scientific discipline; PhD preferred, and MD holders may apply.
• At least 5 years of clinical research experience in pharmaceutical clinical development or equivalent academic experience.
• Knowledge of Good Clinical Practice and regulatory requirements for high-quality oncology clinical trials.
• Experience with protocol development, medical review, study oversight, trial execution, data quality, and safety is strongly preferred.
• Fluent written and spoken English and native-level Japanese proficiency are required.
• Working knowledge of Microsoft Excel and Word is required.

Nice to have

• Experience in oncology.
• Experience with oncology NDA submission and approval.

Culture & Benefits

• Work as part of a global clinical development organization with colleagues across multiple regions.
• Operate with autonomy and decision accountability for Japan clinical matters.
• Potential future development into senior matrix clinical team lead or people leader roles in Japan or internationally.