Distinguished Scientist, Clinical Pathology & Safety Biomarkers

$187,000 - $322,000/Yr

Johnson & Johnson - San Diego, CA

Full-time - Senior

San Diego, CA

Chemical Manufacturing

About the position

The Distinguished Scientist, Clinical Pathology & Safety Biomarkers at Johnson & Johnson is a key role focused on developing and implementing innovative nonclinical safety biomarker strategies to support drug development projects. This position requires a highly experienced individual who operates independently and serves as a subject matter expert, guiding teams and mentoring junior pathologists. The role emphasizes collaboration, communication, and leadership within a diverse team to ensure high-quality safety assessments and regulatory compliance.

Responsibilities

• Independently develops comprehensive fit-for-purpose and innovative nonclinical safety biomarker strategies for projects across modalities and therapeutic areas.
• Guides the implementation of routine and specialized CPSB endpoints in nonclinical studies to ensure generation of timely and high-quality data.
• Delivers high quality, timely and comprehensive evaluations of clinical pathology and biomarker data and interpretive reports.
• Communicates clear, concise, accurate and coherent integrated study conclusions and program recommendations to stakeholders.
• Serves as subject matter expert in responses to health authority queries and reviews regulatory submission documents.
• Provides consultation and guidance to PSTS teams and leadership to support target and candidate molecule confidence.
• Executes the strategic translational safety biomarker vision and leads CPSB strategic initiatives.
• Builds partnerships with internal R&D leaders and the external scientific community to advance Translational Safety Biomarker science.
• Acts as a functional leader, guiding colleagues through consultation, mentoring, and collaborative leadership.
• Creates a purpose-driven environment by aligning strategies and goals with Johnson & Johnson's Credo.

Requirements

• DVM/VMD degree or equivalent is required.
• ACVP board certification in Clinical Pathology is required.
• PhD in Pathology, Toxicology or a related field with a minimum of 10 years post-DVM/PhD residency experience or 15 years of research experience is required.
• Excellent verbal and written communication skills are required.
• Demonstrated ability to work effectively within a diverse team of pathologists and multidisciplinary scientists is required.
• Strong scientific track record with publications in high-quality journals is required.
• Demonstrated competence in all aspects of clinical pathology is required.
• Ability to perform complex data analysis and interpret clinical pathology data is required.

Nice-to-haves

• Experience in developing nonclinical safety strategies in a drug development setting is preferred.
• Experience with data-driven hypothesis-testing approaches is preferred.
• Experience in novel modalities such as cell and gene therapies is preferred.
• Experience with translational safety biomarker development/qualification is preferred.
• Experience with Good Laboratory Practices is preferred.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability insurance
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation time up to 120 hours per year
• Sick time up to 40 hours per year
• Holiday pay including up to 13 days per year
• Work, Personal and Family Time up to 40 hours per year