Senior Principal Scientist – Preclinical Science & Translational Safety

About the role

Johnson & Johnson seeks a Senior Principal Scientist to lead non‑clinical submissions within the Preclinical Science & Translational Safety group in Japan. You will integrate toxicology, safety pharmacology and DMPK data to produce high‑quality regulatory documents for global health authorities.

Key responsibilities

• Ensure timely execution of non‑clinical studies that meet Japanese regulatory requirements and support drug development.
• Prepare and review high‑quality non‑clinical sections for IND/NDA submissions using modern approaches, including AI.
• Collaborate with global and local teams to develop scientific narratives, risk assessments and regulatory strategies.
• Coach and mentor team members, fostering scientific excellence and self‑development.

Required profile

• Minimum 15 years of experience in non‑clinical biology, toxicology, pharmacology or DMPK.
• Deep knowledge of Japanese, EU and US non‑clinical guidelines and IND/NDA processes.
• Advanced presentation, negotiation and communication skills in English with a global mindset.

Required skills

• Toxicology
• Pharmacology
• DMPK
• Non‑clinical regulatory submissions
• Artificial Intelligence (AI) for document preparation