Job Title
Distinguished Scientist, Nonclinical Safety Leader (3 Positions)
Company
Johnson & Johnson
Location
Spring House, Pennsylvania, United States
Hybrid work pattern
Job Function
Discovery & Pre-Clinical/Clinical Development
Job Sub-Function
Nonclinical Safety
Job Category
Distinguished Scientist, Nonclinical Safety (ST9)
Requisition Number
R-019176
Date Posted
September 5, 2025
Application Deadline
September 20, 2025 (may be extended)
Company Overview
Johnson & Johnson is a leader in healthcare innovation dedicated to preventing, treating, and curing complex diseases. Our Innovative Medicine division focuses on developing smarter, less invasive, and personalized healthcare solutions.
Learn more: jnj.com
About Innovative Medicine
Patient-centric science-based advancements
Teams dedicated to developing medicines of tomorrow
Emphasis on translating research from lab to life
Learn more: jnj.com/innovative-medicine
Role Summary
The Distinguished Scientist, Nonclinical Safety (NCS) Leader will provide toxicology leadership across discovery and development projects spanning multiple therapeutic areas and innovative modalities. This role collaborates with cross-functional teams to support candidate molecule nomination, development, and regulatory submission.
Key Responsibilities
Leadership & Collaboration
Lead PSTS project teams of nonclinical safety and pharmacokinetic scientists.
Represent NCS on global project teams and interface with senior management.
Provide mentorship and leadership within the PSTS organization.
Risk Assessment & Safety Evaluation
Create target risk assessments and develop screening and mitigation plans.
Analyze toxicology and safety pharmacology data to prepare nonclinical safety assessments.
Participate in issue-resolution by generating hypotheses and investigative strategies.
Regulatory & Compliance
Prepare global regulatory nonclinical documents and respond to health authorities.
Engage in medical safety teams, signal detection, and risk mitigation strategies.
Conduct nonclinical safety risk assessments for Licensing and Acquisition (L&A) due diligence.
Cross-Functional Collaboration
Collaborate with Chemistry, Manufacturing, and Controls (CMC) functions to assure drug substance quality.
Actively participate in external academic and industry societies to enhance toxicology strategies.
Scientific Expertise
Maintain current scientific knowledge and regulatory landscape awareness for assigned projects.
Communicate effectively with stakeholders, including regulatory authorities.
Qualifications
Education
Master’s degree in Toxicology, Pharmacology, or related discipline required.
Doctoral degree (PhD, DVM, MD, or equivalent) preferred.
Experience
Minimum 15 years relevant pharmaceutical/biotech industry experience with Master’s degree.
Minimum 10 years relevant industry experience with doctoral degree.
Proven experience representing toxicology/nonclinical safety on multi-disciplinary project teams.
Strong understanding of drug discovery and development processes.
Experience in due diligence activities preferred.
Study Director/Study Monitor experience under GLP preferred.
Familiarity with various therapeutic modalities preferred.
Board certification (e.g., DABT) preferred.
Skills
Excellent oral and written communication skills.
Ability to collaborate effectively in cross-functional teams at all levels.
Additional Information
Position is hybrid based in Spring House, PA.
Johnson & Johnson is an Equal Opportunity Employer.
Commitment to an inclusive interview process with accommodations available upon request.
Accommodation Contact
Email: ra-employeehealthsup@its.jnj.com
Or contact AskGS for accommodation resources.
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