Johnson & Johnson Innovative Medicine · 5 hours ago
Distinguished Scientist (Director), Nonclinical Safety Leader (3 Positions)
Spring House, PA
Full-time
Hybrid
Director/Executive
10+ years expJohnson & Johnson Innovative Medicine is a leader in healthcare innovation, focused on developing treatments and cures for complex diseases. The Distinguished Scientist, Nonclinical Safety Leader will provide toxicology leadership for discovery and development projects, collaborating with diverse scientists and ensuring regulatory compliance throughout the drug development process.
Pharmaceuticals
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 Licensing and Acquisition (L&A) opportunities
Collaborate proactively with Chemistry, Manufacturing and Controls (CMC) functions to assure drug substance quality
Actively participate in external academic or industry societies and consortia to enhance toxicology strategies and capabilities
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
Provide leadership and mentorship within the PSTS organization
Lead strategic initiatives as required
Qualification
Required
A minimum of a Master's degree in Toxicology, Pharmacology or a related discipline
A minimum of 15 years of relevant pharmaceutical/biotech industry experience with a Master's degree or a minimum of 10 years of relevant pharmaceutical/biotech industry experience with a doctoral level degree (PhD, DVM, MD or equivalent)
Proven experience in representing toxicology/nonclinical safety on multi-disciplinary project teams
Strong understanding of the drug discovery and development process
Must have excellent oral and written communication skills
The ability to collaborate with all levels in a cross-functional team environment
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 Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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