Principal Toxicologist

Regeneron Pharmaceuticals, Inc (USA); Village of Tarrytown (NY); Vor Ort; USD 151.000 - 246.000; Vollzeit

Benefits dieser Stelle

Annual bonuses or incentives

Equity awards

Pension or retirement benefits

401(k) match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Zusammenfassung

Regeneron Pharmaceuticals, Inc (USA) is seeking a Principal Toxicologist to lead nonclinical development programs within Drug Safety and Pharmacometrics. The role focuses on global regulatory guidance, safety strategy, and collaboration across therapeutic areas to ensure high-quality deliverables.

On-site in Tarrytown, NY. The ideal candidate has an advanced toxicology degree with 5+ years in pharma, strong experience in study design, regulatory submissions, and CRO oversight.

Qualifikationen

• Advanced degree in toxicology or related discipline required.
• 5+ years pharma industry experience with nonclinical safety.
• Experience supporting regulatory submissions (INDs/CTAs/BLAs/MAAs).

Aufgaben

• Represent toxicology on global R&D project teams and set nonclinical safety strategy.
• Develop regulatory risk assessment strategies aligned with program milestones.
• Design and oversee nonclinical safety programs across therapeutic areas.
• Provide scientific oversight of CRO activities and study interpretation.
• Communicate nonclinical safety data to stakeholders and health authorities.
• Contribute to regulatory submissions and interactions with health authorities.
• Mentor junior scientists and drive continuous safety improvements.
• Maintain currency with GLP and ICH/FDA/EMEA guidelines.

Kenntnisse

Regulatory strategy

Cross-functional collaboration

Risk assessment

CRO oversight

Nonclinical safety

Mentoring

Ausbildung

PhD or DVM in Toxicology

Master's +15 yrs exp

Jobbeschreibung

Build our future together: 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.

Location

On‑site in Tarrytown, NY

Discover your role

• Represent 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

We are committed to building a workplace with an inclusive culture. 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. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.

Benefits

• 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
• family support benefits

Salary Range (annually) $150,500.00 - $245,500.00

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.