Oncology Clinical Scientist

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

社内公募ガイドライン

ご経験および面接評価に基づき、ポジションタイトルやグレードが変更となる場合があります。

応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。

在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。

社内紹介を行う場合は、Career Hub/AskGS上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。

＜For Internal Applicants＞

Based on the candidate's experience and interview evaluation, the position title and level may vary.

If you are an employee in Japan, please review the Internal Application Guideline on AskGS before applying. Employees who have been in their current role for less than 18 months must obtain approval from their manager and respective BUHR prior to applying. In addition, employees in Japan may not apply for multiple positions simultaneously.

Regardless of tenure, if you pass the resume screening stage and are invited to a first-round interview, you are required to inform your manager that you have applied for an internal position and are proceeding in the selection process.

If you participate in the Employee Referral Program, please review and understand the Internal Referral Overview on AskGS/Career Hub and ensure that any referral is made in compliance with company policies.

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