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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Clinical Development & Research – Non-MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

ABOUT INNOVATIVE MEDICINE

 

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

 

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

 

Qualifications / Requirements

• 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

 

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

 

 

Required Skills:

 

 

Preferred Skills:

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