Principal Toxicologist

Regeneron Pharmaceuticals; Tarrytown (GA); Presencial; USD 151.000 - 246.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus

Equity awards

Pension plan

401(k) company match

Health benefits

Paid time off

Family support

Descripción de la vacante

Regeneron Pharmaceuticals, a science-driven company, seeks a Principal Toxicologist to lead nonclinical safety programs within Drug Safety and Pharmacometrics. You will guide global regulatory strategy, oversee GLP studies, and mentor scientists across multiple modalities.

Location: On-site in Tarrytown, NY. This senior role emphasizes collaboration with cross-functional teams, timely delivery of high-quality data for regulatory submissions, and ongoing professional development in a fast-growing

Formación

• Demonstrated expertise in design, oversight, interpretation, and reporting of nonclinical safety studies for drug development.
• Experience as nonclinical safety representative on cross-functional teams and contributing to regulatory submissions (INDs, CTAs, BLAs/MAAs).
• Strong knowledge of global regulatory requirements and nonclinical safety strategies across development stages.

Responsabilidades

• Represent toxicology on global research and development project teams, communicating non-clinical safety strategy.
• Develop regulatory risk assessment strategies and contribute to program planning, budgeting, and execution of toxicology studies.
• Collaborate with cross-functional experts to design and execute nonclinical safety programs for drug development.
• Provide scientific oversight of CRO activities including study design, conduct, data interpretation, and reporting.
• Communicate nonclinical safety data and development strategies to internal and external stakeholders and regulatory agencies.
• Author and review nonclinical safety content for global regulatory submissions with health authorities.
• Mentor junior scientists to promote scientific excellence and professional development.

Conocimientos

Nonclinical safety

Regulatory submissions

GLP regulations

Cross-functional collaboration

Mentoring

Educación

PhD or DVM

Master's degree

Herramientas

CRO oversight

Descripción del empleo

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.

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

Does this sound like you? 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. 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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$150,500.00 - $245,500.00