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Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Nonclinical Safety

Job Category:

Scientific/Technology

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

As a Principal/Senior Principal Scientist responsible for nonclinical submissions within Preclinical Science and Translational Safety (PSTS), you will integrate nonclinical data—including toxicology, safety pharmacology, and DMPK—and lead the high‑quality and timely preparation and review of nonclinical sections for regulatory submission documents intended for global health authorities. You will collaborate with internal and external experts to develop clear scientific narratives and risk assessments, and work closely with the global dossier team to contribute to pipeline advancement across therapeutic areas

JOB SUMMARY:

1. Conduct 1) to 4) below in the non-clinical area with global mind set.

　1) Ensure appropriate studies are conducted at appropriate times to support drug development in Japan

　2) Ensure study results and their interpretation meet Japanese regulatory requirements.

　3) Ensure resolution to all project-related problems that might affect development in Japan.

　4) Ensure non-clinical submissions are of the highest scientific quality, and these are prepared within timelines by using modern approaches, including AI.

1. Focus on self-evaluation, self-management and self-development.

2. Scientific educate and coach the members.

3. Make close/tight relationships with Global team and plan/execute strategy of scientific/regulatory matters

4. Shape regulatory acceptance aligned with international standards through external/industry activities.

KEY RESPONSIBILITIES:

1. Conduct 1) to 9) below in the non-clinical area with global mind set.

　1) Research global documents and published papers and see whether or not the study items and/or results meet requirements by the Japanese regulatory authorities and see whether or not there is a critical issue against clinical studies and/or NDAs.

　2) Make and discuss possible resolutions to a problem for clinical studies and/or NDAs with relevant colleagues and put the most appropriate resolution (e.g. additional studies and/or documentation) into practice.

　3) Prepare high-quality non-clinical documents for clinical studies and/or NDAs by using modern approaches, including AI.

　4) Prepare high-quality non-clinical responses to inquiries for clinical studies and/or NDA's in cooperation with Global, JPKK and/or external experts.

　5) Provide support for preparing high-quality documents for marketing.

　6) Discuss the requests for non-clinical studies from external investigators with relevant colleagues and perform joint studies if needed.

　7) Provide relevant colleagues with suggestions from non-clinical perspectives.

　8) Establish, maintain and improve relationships to relevant colleagues and external experts.

　9) Support the members, and check the documents and/or responses prepared by the members in terms of science and quality

　10) Use sound scientific and logical justifications to bring PMDA acceptance more aligned with ICH guidelines and other major Global HA (e.g. FDA, EMEA, CDE, etc.) to minimize the amount of work required specifically for Japan approvals.

1. Give scientific feedback and coaching to the members and support development of members.

REQUIREMENTS:

Experience/Knowledge

• Expert knowledge of the non-clinical area (strong background in biology, toxicology, pharmacology, DMPK), advanced knowledge of non-clinical

notifications/guidance/guidelines in Japan/EU/US, advanced knowledge of processes for IND/NDA, advanced knowledge of other non-clinical areas, and

intermediate knowledge of clinical areas.

• Experience in non-clinical areas for more than 15 years or equivalent to the experience.

• Experience with activities outside the company or department

Skills/Capabilities

• Advanced presentation and negotiation skills with global mindset.

• Advanced communication skills in English.

• Advanced scientific skills in managing and developing the group members, including coaching, feedback and mentoring.

• Advance negotiation and influencing skills

• Challenges the status quo and embraces new ways of doing things

＜For Internal Applicants＞・ Based on your experience and interview evaluation, the position title and level may vary.

・ If you are a Japan employee, please read the “Internal Application Guideline” in Ask GS. Especially if you have been in your current role for less than 18 months, you are required to obtain application approval from your current manager as well as your respective BUHR. If you are a Japan employee, you are not able to apply for multiple positions at once.

・ For Employee Referral Program (ERP), please read and understand the details of the “Internal Referral Overview” on Ask GS and ensure you have made a compliant referral.

Required Skills:

Preferred Skills:

Clinical Data Management, Drug Discovery Development, EHS Compliance, Emergency Planning, Performance Measurement, Presentation Design, Process Hazard Analysis (PHA), Process Optimization, Program Management, Regulatory Affairs Management, Research and Development, Risk Management, Safety Audits, Safety Investigations, Safety-Oriented, Scientific Research, Strategic Thinking, Tactical Planning, Technical Credibility