Senior Investigator – Clinical Pathologist

Senior Investigator – Clinical Pathologist
The clinical pathologist provides expertise to research and preclinical safety studies through well-written reports that accurately reflect data derived from standard clinical pathology endpoints as well as investigative biomarkers and immunotoxicological assessments. In conjunction with the study teams, the pathologist contributes an integrated assessment of the significance of study findings to human safety within regulatory submission packages. Actively participates in the global drug development process through contributions as Project Pathologist on assigned drug targets and also has the opportunity to serve as the safety assessment expert on project teams. In addition, works collaboratively within our pathology and investigative safety teams to build our scientific and technical expertise in translational biomarkers and technologies used to support safety studies and in-vivo safety models.

Major Accountabilities

• Effectively assess for pharmacological and toxicological effects of small molecules and biologics in preclinical studies, with a focus on clinical pathology, soluble biomarkers, and immunotoxicology.
• Collaborate with global team of pathologists and other scientists in design of preclinical safety studies and interpretation and communication of study findings, including the impact of the data on the safety profile and clinical development.
• Provide oversight of review of protocols, data, and reports generated at contract laboratories and maintain effective relationships with CRO clinical pathologists, scientists, and technical staff to ensure high quality, on-time reporting.
• Drive scientific and technical support for identification, development, qualification, and validation of translational biomarkers and immunological-based endpoints through collaboration with global biomarker and immunotoxicology teams and internal and external expert working groups.
• Support continuous development of laboratory analytical capabilities and career development of the technical team in collaboration with the laboratory manager.
• Serve as Project Pathologist on assigned compounds, targets, and therapeutic areas.
• Opportunity to participate as safety assessment expert on global drug development project teams
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
• Doctor of Veterinary Medicine or equivalent
• Board Certification in Clinical Pathology by European/American College of Veterinary Pathologists (ECVP or ACVP)
• Preferred: PhD in a biological science
• Experience in toxicological pathology/clinical pathology. Preferred: Experience in development of novel biomarkers and/or immunotoxicological methods (flow cytometry, multiplex technology, immunoassays) and application in safety assessment, preferably within pharmaceutical/biotech or contract research organization
• Good understanding of the drug development process, preferably including experience working directly on drug development project teams and Regulatory interactions and submissions
• Excellent verbal and written communication skills
• Ability to work cross-functionally within a team and matrix environment
Translational Medicine
East Hanover, NJ
Novartis Pharmaceuticals
Research & Development
Full Time