Senior Toxicologist: Global Nonclinical Lead

Regeneron; Cambridge (MA); On-site; USD 128,600 - 210,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k) match

Health benefits

Paid time off

Job summary

Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep GLP and regulatory expertise to design, conduct, and report studies in rodent and non‑rodent models while aligning with FDA/ICH/EMEA guidelines.

Ideal candidates will have an advanced degree and 3–5 years in pharma, or a Master’s with 10+ years, and experience coordinating multi‑team studies and regulatory submissions.

Qualifications

• Advanced degree with 3–5 years relevant pharmaceutical industry experience, or Master’s degree with 10 years experience.
• Experience in designing, monitoring and interpreting non‑clinical safety studies.

Responsibilities

• Represent toxicology on global R&D project teams communicating non‑clinical safety assessment strategy.
• Coordinate cross‑department execution of the experimental plan including program budgets and timing of toxicology studies.
• Work with study monitoring group to coordinate, design, monitor, and report toxicology and safety pharmacology studies at CROs.
• Communicate toxicology study findings, including interpretation, to project teams and management.
• Contribute to non‑clinical sections of regulatory documents including IND and NDA submissions.
• Maintain currency with GLP regulations and ICH, FDA and EMEA non‑clinical safety guidelines.
• Keep up with the latest scientific developments by reading literature and attending conferences.

Skills

Regulatory experience

GLP regulations knowledge

Nonclinical toxicology

Cross-functional teamwork

Education

PhD or DVM in pharmacology/toxicology or related

Master's degree + 10 years experience

Job description

Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep GLP and regulatory expertise to design, conduct, and report studies in rodent and non‑rodent models while aligning with FDA/ICH/EMEA guidelines.

Ideal candidates will have an advanced degree and 3–5 years in pharma, or a Master’s with 10+ years, and experience coordinating multi‑team studies and regulatory submissions.