Senior Preclinical Safety Scientist — Toxicology & Regulation

Sanofi Group; Somerville (MA); On-site; USD 170,000 - 240,000; Full time

Benefits offered by this job

Excellent benefits

Growth opportunities

Global team exposure

Job summary

Sanofi is seeking a senior toxicology expert to oversee nonclinical safety programs in early to late development. You will design safety studies, author regulatory documents, and interact with project teams and regulatory partners to ensure high scientific standards.

The role emphasizes leadership in reproductive and developmental toxicity and opportunities to present findings at internal and external venues. On-site in Somerville, MA with a global team.

Qualifications

• 12+ years of pharma industry drug development experience including preclinical safety and toxicology.
• Strong knowledge of GLP/ICH and regulatory nonclinical testing requirements.
• Experience preparing and submitting IND and CTD submissions.
• Excellent written and verbal communication and presentation skills.

Responsibilities

• Serve as a Preclinical Safety Project Team Member on multi-functional R&D Project Teams for small molecules, biologics, and other modalities.
• Develop and implement toxicology and safety pharmacology strategies.
• Support nonclinical safety activities for early- and late-stage development and lifecycle management.
• Write nonclinical summaries for regulatory documents and assist other PTMs as needed.
• Review internal and external reports to provide preclinical safety perspective.
• Ensure high scientific standards in nonclinical safety studies.
• Provide internal leadership on reproductive and developmental toxicity studies when applicable.
• Prepare scientific publications and presentations from toxicology studies.

Skills

Excellent communication

IND/CTD submissions

GLP & ICH knowledge

Scientific writing

Education

PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or closely related field

12+ years of pharma industry experience in drug development

Job description

Sanofi is seeking a senior toxicology expert to oversee nonclinical safety programs in early to late development. You will design safety studies, author regulatory documents, and interact with project teams and regulatory partners to ensure high scientific standards.

The role emphasizes leadership in reproductive and developmental toxicity and opportunities to present findings at internal and external venues. On-site in Somerville, MA with a global team.