Oncology Clinical Scientist

Johnson & Johnson is hiring an Oncology Clinical Scientist in Tokyo, Japan. Level rates it ; you can apply on Johnson & Johnson.

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Level rates this role Little AI ●○○○: aI is not part of the work.
Level classes it as a senior role.
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AI in this role

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. Learn more at jnj.com.

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.

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

How we rate this

Oncology Clinical Scientist at Johnson & Johnson rates 38 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.