Distinguished Scientist, Safety Assessment Project Expert
Sanofi
August 21, 2026
Remote friendly (Morristown, NJ)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Main Responsibilities
- Serve as a Preclinical Safety Project Team Member on multi-functional R&D project teams (small molecules, biotherapeutics, oligonucleotides, and other modalities); develop and implement toxicology and safety pharmacology strategies.
- Support nonclinical safety activities across early-/late-stage development and Life Cycle Management/marketed products.
- Write nonclinical summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents; review internal/external reports to provide scientific preclinical safety perspective.
- Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies; provide leadership with experience interpreting reproductive and developmental toxicity (preferred).
- Provide internal expertise for global nonclinical safety issues for committees/expert groups; prepare publications and presentations.
- Participate in special projects/inter-industry working groups.
- Provide scientific input on R&D study design and analysis, including in-licensing opportunity evaluations.
Qualifications
- PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field; 12+ years pharmaceutical industry experience.
- Demonstrated knowledge of GLP and ICH policies and regulatory nonclinical testing requirements.
- Demonstrated experience preparing and submitting IND and CTD submissions.
Minimum/Preferred Skills
- Experience as a GLP Study Director.
- Experience with ophthalmology toxicity study conduct and interpretation.
- Certification by the American Board of Toxicology.
- Excellent presentation and writing skills.
- English.
Benefits
- At least 14 weeks’ gender-neutral parental leave.
- Serve as a Preclinical Safety Project Team Member on multi-functional R&D project teams (small molecules, biotherapeutics, oligonucleotides, and other modalities); develop and implement toxicology and safety pharmacology strategies.
- Support nonclinical safety activities across early-/late-stage development and Life Cycle Management/marketed products.
- Write nonclinical summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents; review internal/external reports to provide scientific preclinical safety perspective.
- Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies; provide leadership with experience interpreting reproductive and developmental toxicity (preferred).
- Provide internal expertise for global nonclinical safety issues for committees/expert groups; prepare publications and presentations.
- Participate in special projects/inter-industry working groups.
- Provide scientific input on R&D study design and analysis, including in-licensing opportunity evaluations.
Qualifications
- PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field; 12+ years pharmaceutical industry experience.
- Demonstrated knowledge of GLP and ICH policies and regulatory nonclinical testing requirements.
- Demonstrated experience preparing and submitting IND and CTD submissions.
Minimum/Preferred Skills
- Experience as a GLP Study Director.
- Experience with ophthalmology toxicity study conduct and interpretation.
- Certification by the American Board of Toxicology.
- Excellent presentation and writing skills.
- English.
Benefits
- At least 14 weeks’ gender-neutral parental leave.