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Distinguished Scientist, Nonclinical Safety Leader

10-15 years
Not Disclosed
3 Sept. 10, 2025
Job Description
Job Type: Full Time Education: PhD, DVM, MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.


Tags

#LI-Hybrid