Principal Toxicologist

Regeneron Pharmaceuticals•Tarrytown, GA

6d•$150,500 - $245,500•Onsite

About The Position

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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

Nice To Haves

Experience across diverse therapeutic modalities, such as monoclonal antibodies, oligonucleotides, and gene therapies
Prior experience providing toxicology and nonclinical safety support for Ophthalmology, Oncology, and/or Infectious Diseases programs

Responsibilities

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