Senior Manager, Oncology, Clinical Science (Oncology)

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

Company

Johnson & Johnson Innovative Medicine develops medicines for significant unmet medical needs, including oncology, immunology, neuroscience, and cardiovascular and metabolic diseases.

What you will do

• Lead Japan clinical input into global oncology clinical development strategies within a matrix team.
• Oversee the execution, quality, and consistency of oncology clinical studies across assigned development programs.
• Lead the clinical aspects of PMDA and MHLW interactions and support regulatory document development, JNDA preparation, and responses to PMDA questions.
• Collaborate with global clinical leads and functions including Clinical Operations, Data Management, Statistics, Regulatory, and Medical Writing.
• Review eligibility, efficacy, safety, coding, protocol deviations, serious adverse events, and clinical data queries.
• Mentor and supervise clinical project physicians and scientists and interact with investigators, key opinion leaders, business partners, and medical consultants.

Requirements

• Bachelor’s degree or higher 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 clinical development.
• Experience with oncology NDA submission and approval.
• Experience supporting external clinical research opportunities, evidence generation planning, investigator meetings, advisory boards, or independent data monitoring committees.

Culture & Benefits

• Work within a global, collaborative clinical development organization.
• Operate with autonomy for Japan-specific matters and accountability for project decisions.
• Collaborate with colleagues and stakeholders across international locations.
• Future development opportunities include senior matrix clinical team leadership and people leadership roles in Japan or internationally.