Principal Toxicologist
Regeneron Pharmaceuticals
Summary
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Principal Toxicologist to join our Toxicology group within Drug Safety and Pharmacometrics, applying scientific and regulatory expertise to lead nonclinical development programs with minimal supervision. You'll have a deep understanding of global regulatory guidelines to ensure all aspects of nonclinical safety are met, enabling progression of assigned programs across the life cycle of a therapeutic asset. You'll manage all aspects of multiple programs across therapeutic classes, demonstrating the ability to prioritize and meet deadlines with high-quality deliverables, and will work in collaboration with other members of the toxicology group to develop policies and procedures related to the conduct of toxicology research at Regeneron. Candidates with experience across diverse therapeutic modalities, such as monoclonal antibodies, oligonucleotides, and gene therapies, are preferred. Prior experience providing toxicology and nonclinical safety support for Ophthalmology, Oncology, and/or Infectious Diseases programs is a plus.
Job description
When & where
- Location: On-site in Tarrytown, NY
Discover your role
- Represents toxicology on global research and development project teams, communicating non-clinical safety strategy
- Develops regulatory risk assessment strategies and contributes to program planning, budgeting, and the execution of toxicology studies to support regulatory and clinical development milestones
- Collaborates with cross-functional subject matter experts to design and execute nonclinical safety programs that support drug development and clinical advancement
- Provides scientific oversight of CRO activities, including study design, conduct, monitoring, data interpretation, and reporting
- Communicates nonclinical safety data, risk assessments, and development strategies to internal and external stakeholders, including regulatory agencies
- Authors and reviews nonclinical safety content for global regulatory submissions and provides toxicology expertise in interactions with health authorities
- Collaborates with external partners and consultants to advance nonclinical safety strategies and support drug development programs
- Maintains currency with GLP regulations and ICH, FDA, and EMEA non-clinical safety guidelines
- Keeps up with the latest scientific developments by reading current literature and attending conferences
- Drives continuous improvement initiatives and mentors junior scientists to promote scientific excellence and professional development
This role requires
- Advanced Degree (e.g., PhD, DVM) in Toxicology or a closely related discipline, plus 5+ years, or a Master's Degree plus 15+ years, of relevant pharmaceutical industry experience
- Demonstrated expertise in the design, oversight, interpretation, and reporting of nonclinical safety assessment studies supporting drug development
- Proven experience serving as the nonclinical safety representative on cross-functional drug development teams and contributing to regulatory submissions (e.g., INDs, CTAs, BLAs/MAAs)
- Strong knowledge of global regulatory requirements and nonclinical safety strategies across all stages of pharmaceutical development
Requirements
- Advanced Degree (e.g., PhD, DVM) in Toxicology or a closely related discipline, plus 5+ years, or a Master's Degree plus 15+ years, of relevant pharmaceutical industry experience
- Demonstrated expertise in the design, oversight, interpretation, and reporting of nonclinical safety assessment studies supporting drug development
- Proven experience serving as the nonclinical safety representative on cross-functional drug development teams and contributing to regulatory submissions (e.g., INDs, CTAs, BLAs/MAAs)
- Strong knowledge of global regulatory requirements and nonclinical safety strategies across all stages of pharmaceutical development
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.