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About the Role

Drive the development and execution of the Japan Clinical Development Plan for innovative oncology medicines, aligning with global strategies. Provide clinical science support for studies in Japan, from protocol development to PMDA interactions, and lead regulatory submissions for approval. Contribute to global studies as a Study Responsible Scientist.

Responsibilities

Contribute to Japan clinical development strategies aligned to global asset and program plans, and draft Japan local protocols, amendments and planning documents
Lead local companion diagnostic (CDx) development with support from the global CDx team
Provide clinical oversight of trials in Japan, partnering with Clinical Operations on feasibility, investigator interactions, site training, enrolment and protocol interpretation
Support and perform eligibility and medical review, and interpret study results with the broader study team to inform trial conduct, development strategy and regulatory decisions
Contribute to key clinical documents, including clinical study reports, protocols, informed consent documents and CRFs, through section authorship and quality control
Prepare clinical sections of Japan regulatory submissions and responses to PMDA inquiries, and participate in PMDA consultation meetings
Contribute to global study activities when assigned as a Global Study Responsible Scientist (SRS)

Requirements

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

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

Location

Chiyoda, Tokyo, Japan

Work Type

Full-time

Experience Level

Manager
5 years

Education Level

Bachelor's degree or above in biology, pharmacology or a related scientific field; PhD preferred

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
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.

Equal Opportunity

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.