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About the Role

The Senior Toxicologist leads nonclinical development programs, utilizing scientific expertise and regulatory experience within cross-functional project teams. This role requires a thorough understanding of GLP regulations and FDA/EMEA/ICH nonclinical safety guidelines to independently design, conduct, interpret, and report toxicology studies. The position involves primary authorship of regulatory documentation for submission packages and requires excellent problem-solving and communication skills.

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 the 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 current literature and attending conferences.

Requirements

Advanced degree (e.g., PhD, DVM) in pharmacology, toxicology, or a closely related biological science along with 3-5 years of relevant pharmaceutical industry experience.
Master’s Degree + ≥ 10 years of relevant pharmaceutical industry experience in designing, monitoring, and interpreting non-clinical safety studies.
Experience with multiple therapeutic modalities preferred, including antibody, oligonucleotide, and gene therapy products.

Skills

Scientific expertise
Regulatory experience
GLP regulations
FDA/EMEA/ICH nonclinical safety guidelines
Problem-solving skills
Written communication skills
Verbal communication skills

Location

On-site

Work Type

Full-time

Experience Level

Senior

Education Level

PhD
DVM
Master's Degree

Salary/Compensations

$128,600.00 - $210,000.00

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

About the Company

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.
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 its 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.

Equal Opportunity

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.
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.