Johnson & Johnson · 3 months ago
Senior Principal Scientist, Nonclinical Safety Lead
Spring House, Pennsylvania, United States of America
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expJohnson & Johnson is a leader in healthcare innovation, focusing on developing treatments and cures for complex diseases. The Senior Principal Scientist, Nonclinical Safety Lead will provide toxicology leadership in discovery and development projects, collaborating with diverse scientists to ensure safety and regulatory compliance throughout the drug development process.
Hospital & Health Care
Responsibilities
Lead PSTS project teams of nonclinical safety and Pharmacokinetic (PK) scientists, ensuring efficient information transfer within the team
Serve as the NCS representative for global project teams, providing toxicology expertise and interfacing with senior management
Create target risk assessments and develop plans to screen for and mitigate potential risks; analyze toxicology and safety pharmacology studies, contextualizing results for human safety and preparing nonclinical safety assessments
Contribute to issue-resolution teams by generating hypotheses and investigative strategies
Accountable for global regulatory nonclinical documents and health authority responses to support clinical trials and compound registrations
Participate in medical safety teams, signal detection analyses, and risk mitigation strategies
Engage in nonclinical safety risk assessments for due diligence of potential L&A opportunities, as needed
Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality
Participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities, as needed
Maintain scientific depth and knowledge in competitive intelligence and regulatory landscapes for assigned projects
Communicate effectively with stakeholders, including regulatory authorities, leveraging drug development experience
Qualification
Required
A minimum of a Master's degree in Toxicology, Pharmacology or a related discipline
A minimum of 12 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a Master's degree
A minimum of 8 years of pharmaceutical/biotech industry experience in pre-clinical safety assessment supporting discovery/development with a doctoral level degree (PhD, DVM, MD or equivalent)
Experience in representing toxicology/nonclinical safety on multi-disciplinary project teams
Strong understanding of the drug discovery/development process
Must have excellent oral and written communication skills
The ability to critically evaluate, interpret and integrate large datasets and literature
Preferred
Doctoral level degree (PhD, DVM, MD or equivalent) in Toxicology, Pharmacology or related discipline
Experience in conducting due diligence activities
Previous experience as a Study Director/Study Monitor under Good Laboratory Practice (GLP) regulations
Familiarity with various therapeutic modalities
Board certification (e.g. Diplomate of the American Board of Toxicology (DABT))
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
Company data provided by crunchbase