Senior Toxicologist

Regeneron Pharmaceuticals, Inc (USA); Cambridge (MA); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc (USA) is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from their supervisor, collaborating within cross-functional project teams.

The role requires deep knowledge of GLP regulations and FDA/ICH safety guidelines, with primary responsibility for designing, conducting, interpreting, and reporting regulatory toxicology studies and related pharmacology work in rodent and non-rodent models.

Qualifikationen

• Advanced degree in pharmacology, toxicology, or closely related biology with 3–5 years pharmaceutical industry experience.
• Or Master’s Degree + 10+ years relevant pharmaceutical industry experience in designing, monitoring and interpreting non-clinical safety studies.
• Experience with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines.

Aufgaben

• 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.
• 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 interpretation, to project teams and management.
• Contribute to non-clinical sections of regulatory documents including IND and NDA submissions.
• Keep up with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines.
• Stay current with literature and attend conferences.

Kenntnisse

GLP experience

Regulatory documentation

FDA/ICH guidelines

Scientific writing

Cross-functional teamwork

Ausbildung

PhD in pharmacology/toxicology

DVM

Master’s degree in related field

Jobbeschreibung

Senior Toxicologist

The Senior Toxicologist utilizes their scientific expertise and regulatory experience to lead nonclinical development programs with guidance from their direct supervisor working effectively within cross‑functional project teams. The Senior Toxicologist will demonstrate a thorough understanding of GLP regulations and FDA/EMEA/ICH nonclinical safety guidelines to independently lead the design, conduct, interpretation, and reporting of regulatory toxicology and/or exploratory pharmacology/toxicology studies in rodent and non‑rodent safety models. The Senior Toxicologist will provide primary authorship of all regulatory documentation required for submission packages, demonstrating excellent problem‑solving and communication skills (written and verbal). Experience with multiple therapeutic modalities preferred, including antibody, oligonucleotide, and gene‑therapy products.

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 the current literature and attending conferences.

Requirements

• Advanced degree (e.g. PhD, DVM) in pharmacology, toxicology or closely related biological science along with 3-5 years relevant pharmaceutical industry experience.
• Or Master’s Degree + ≥10 years relevant pharmaceutical industry experience in designing, monitoring and interpreting non‑clinical safety studies.

Equal Opportunity Employment

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.