Distinguished Scientist, Safety Assessment Project Expert
Sanofi
August 21, 2026
Remote friendly (Cambridge, MA)
United States
$178,500 - $257,833.33 USD yearly
Clinical Research and Development
Main Responsibilities:
- Serve as a Preclinical Safety Project Team Member (PTM) on multi-functional R&D teams across modalities (small molecules, biotherapeutics, oligonucleotides, etc.); develop and implement toxicology and safety pharmacology strategies for early-/late-stage development and life cycle management/marketed products.
- Author nonclinical regulatory summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents; review internal/external reports and data to provide preclinical safety perspective.
- Ensure high scientific standards in nonclinical safety and investigative toxicology studies; provide leadership with experience in reproductive and developmental toxicity (preferred).
- Provide internal expertise for global nonclinical safety issues; 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 evaluations.
Qualifications:
- PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field; 12+ years pharmaceutical industry experience.
- Knowledge of GLP and ICH policies and regulatory nonclinical testing requirements.
- Experience preparing and submitting IND and CTD submissions.
Minimum/Preferred Skills:
- Experience as a GLP Study Director.
- Experience with ophthalmology toxicity studies and data.
- Certification by the American Board of Toxicology (preferred).
- Excellent presentation and writing skills.
- English.
Benefits (as stated):
- Excellent benefits and compensation; high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.
- Serve as a Preclinical Safety Project Team Member (PTM) on multi-functional R&D teams across modalities (small molecules, biotherapeutics, oligonucleotides, etc.); develop and implement toxicology and safety pharmacology strategies for early-/late-stage development and life cycle management/marketed products.
- Author nonclinical regulatory summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents; review internal/external reports and data to provide preclinical safety perspective.
- Ensure high scientific standards in nonclinical safety and investigative toxicology studies; provide leadership with experience in reproductive and developmental toxicity (preferred).
- Provide internal expertise for global nonclinical safety issues; 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 evaluations.
Qualifications:
- PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field; 12+ years pharmaceutical industry experience.
- Knowledge of GLP and ICH policies and regulatory nonclinical testing requirements.
- Experience preparing and submitting IND and CTD submissions.
Minimum/Preferred Skills:
- Experience as a GLP Study Director.
- Experience with ophthalmology toxicity studies and data.
- Certification by the American Board of Toxicology (preferred).
- Excellent presentation and writing skills.
- English.
Benefits (as stated):
- Excellent benefits and compensation; high-quality healthcare and prevention/wellness programs; at least 14 weeks’ gender-neutral parental leave.