Senior Toxicologist – Global Nonclinical Lead

BioSpace; Cambridge (MA); Presencial; USD 129.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Descripción de la vacante

Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying deep regulatory expertise to design, conduct, and report toxicology studies in rodents and non-rodents.

The role emphasizes primary authorship of regulatory documentation for submission packages, with strong problem-solving and communication skills. Prior experience across modalities is preferred.

Formación

• Regulatory toxicology expertise required.
• Experience with GLP studies and interpreting regulatory guidelines.
• Strong written and verbal communication for regulatory documents.

Responsabilidades

• Represent toxicology on global R&D teams and communicate non-clinical safety strategy.
• Coordinate cross-department execution of toxicology plans and timelines.
• Work with CROs to design, monitor, and report non-clinical studies.
• Communicate study findings and interpretations to project teams and management.
• Contribute to non-clinical sections of IND/NDA submissions.
• Maintain currency with GLP, ICH, FDA and EMEA guidelines.
• Keep current with scientific developments through literature and conferences.

Conocimientos

Regulatory toxicology knowledge

GLP regulations

FDA/EMEA/ICH guidelines

Cross-functional collaboration

Educación

PhD or DVM

Master's + 10 years industry

Descripción del empleo

Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying deep regulatory expertise to design, conduct, and report toxicology studies in rodents and non-rodents.

The role emphasizes primary authorship of regulatory documentation for submission packages, with strong problem-solving and communication skills. Prior experience across modalities is preferred.