Senior Toxicologist
Regeneron
August 06, 2026
On-site
Cambridge, MA
Clinical Research and Development
Role Overview
- Lead nonclinical development programs within cross-functional teams, independently designing, conducting, interpreting, and reporting regulatory toxicology and/or exploratory pharmacology/toxicology studies in rodent and non-rodent safety models.
- Provide primary authorship of regulatory documentation required for submission packages.
Preferred Skills/Experience
- Experience with multiple therapeutic modalities, including antibody, oligonucleotide, and gene therapy products.
Job Responsibilities
- Represent toxicology on global R&D project teams and communicate non-clinical safety assessment strategy.
- Coordinate cross-department execution of the experimental plan (budgets and timing aligned to regulatory/clinical milestones).
- Coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
- Communicate study findings and interpretations to project teams and management.
- Contribute to non-clinical regulatory sections of IND and NDA submissions.
- Maintain currency with GLP regulations and ICH/FDA/EMEA non-clinical safety guidelines.
- Stay current with scientific literature and attend conferences.
Job Requirements
- Advanced degree (e.g., PhD, DVM) in pharmacology, toxicology, or closely related biological science with 3–5 years relevant pharmaceutical industry experience; or Master’s degree with ≥10 years relevant pharmaceutical industry experience.
- Experience designing, monitoring, and interpreting non-clinical safety studies.
Application
- Apply now.
- Lead nonclinical development programs within cross-functional teams, independently designing, conducting, interpreting, and reporting regulatory toxicology and/or exploratory pharmacology/toxicology studies in rodent and non-rodent safety models.
- Provide primary authorship of regulatory documentation required for submission packages.
Preferred Skills/Experience
- Experience with multiple therapeutic modalities, including antibody, oligonucleotide, and gene therapy products.
Job Responsibilities
- Represent toxicology on global R&D project teams and communicate non-clinical safety assessment strategy.
- Coordinate cross-department execution of the experimental plan (budgets and timing aligned to regulatory/clinical milestones).
- Coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
- Communicate study findings and interpretations to project teams and management.
- Contribute to non-clinical regulatory sections of IND and NDA submissions.
- Maintain currency with GLP regulations and ICH/FDA/EMEA non-clinical safety guidelines.
- Stay current with scientific literature and attend conferences.
Job Requirements
- Advanced degree (e.g., PhD, DVM) in pharmacology, toxicology, or closely related biological science with 3–5 years relevant pharmaceutical industry experience; or Master’s degree with ≥10 years relevant pharmaceutical industry experience.
- Experience designing, monitoring, and interpreting non-clinical safety studies.
Application
- Apply now.