Senior Toxicologist

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

The Senior Toxicologist utilizes their scientific expertise and regulatory experience to lead nonclinical development programs with guidance from their direct supervisor working effectively within cross‑functional project teams. The Sr. Toxicologist will demonstrate a thorough understanding of GLP regulations and FDA/EMEA/ICH nonclinical safety guidelines to independently lead the design, conduct, interpretation, and reporting of regulatory toxicology and/or exploratory pharmacology/toxicology studies in rodent and non‑rodent safety models.

Experience with multiple therapeutic modalities preferred, including antibody, oligonucleotide, and gene‑therapy products.

Job Responsibilities

• Represent toxicology on global research and development project teams communicating non‑clinical safety assessment strategy.
• Coordinate cross‑department execution of the experimental plan including program budgets, and timing of toxicology studies in relation to regulatory and clinical milestones.
• Work with study monitoring group to coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
• Communicate toxicology study findings, including relevant 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 the current literature and attending conferences.

Job Requirements

• Advanced degree (e.g. PhD, DVM) in pharmacology, toxicology or closely related biological science along with 3-5 years relevant pharmaceutical industry experience, or Master’s Degree + 10 years relevant pharmaceutical industry experience.
• Experience in designing, monitoring and interpreting non‑clinical safety studies.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Salary Range (annually): $128,600.00 - $210,000.00