Distinguished Scientist, Safety Assessment Project Expert

Position Summary

A Preclinical Safety Toxicologist will support cross‑functional research and development teams by designing, executing, and interpreting toxicology and safety pharmacology studies across small molecules, biotherapeutics, oligonucleotides, and other modalities. The role involves strategic planning of nonclinical safety programs, preparing regulatory documents, and providing scientific leadership to ensure the highest scientific standards in drug development.

• Serve as a Preclinical Safety Project Team Member (PTM) on multi‑functional R&D projects.
• Formulate nonclinical safety strategies and design safety pharmacology and toxicology studies across early and late‑stage development, as well as Life Cycle Management.
• Write and review nonclinical summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory submissions.
• Review reports and documentation from internal teams and external contract laboratories to provide preclinical safety scientific perspective.
• Ensure high scientific standards in the conduct, analysis, and reporting of nonclinical safety and investigative toxicology studies.
• Provide scientific leadership, especially in reproductive and developmental toxicity studies, and serve on expert groups or internal committees addressing global nonclinical safety issues.
• Prepare scientific publications and presentations from toxicology and safety pharmacology studies.
• Participate in special projects or inter‑industry working groups as required.
• Advise on design and analysis of R&D activities, including evaluation of external opportunities for in‑licensing, ensuring activities meet the highest scientific standards.

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or a related field.
• Minimum 12+ years of pharmaceutical industry experience with demonstration of GLP and ICH policies and regulatory nonclinical testing requirements.
• Experience preparing and submitting IND and CTD regulatory submissions.
• Preferred: GLP Study Director experience and experience in ophthalmology toxicity studies.

• Excellent presentation and writing skills.

• English (written and spoken).

Salary range: $ - $. Compensation will be determined based on demonstrated experience.

Comprehensive benefits that include high‑quality healthcare, wellness programs, preventive services, and at least 14 weeks of gender‑neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status;

domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.