Sanofi · 17 hours ago
Distinguished Scientist, Safety Assessment Project Expert
Cambridge, MA
Full-time
Hybrid
Lead/Staff
$178K/yr - $258K/yr
12+ years expSanofi is an R&D-driven, AI-powered biopharma company committed to improving people’s lives. They are seeking a Distinguished Scientist, Safety Assessment Project Expert to oversee the nonclinical safety program of drug candidates, formulate safety strategies, and interact with regulatory agencies and project teams.
Health CareLife SciencePharmaceuticalTherapeutics
Responsibilities
Serve as a Preclinical Safety Project Team Member (PTM) on multi-functional Research and Development Project Teams on small molecules, biotherapeutics, oligonucleotides, and other modalities. Support the development of new products, develop and implement toxicology and safety pharmacology strategies. Support needed nonclinical safety activities for early-/late-stage development and Life Cycle Management/marketed products
Write nonclinical summaries for clinical Investigator Brochures, INDs, CTAs and NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents and or assist other PTMs in such activities as needed. Review reports and other documentation authored by internal personnel (e.g. Preclinical Safety, other Project Team functions) and/or external contract laboratories to provide the appropriate preclinical safety scientific perspective
Ensure high scientific standards in conducting and reporting of nonclinical safety and investigative toxicology studies. Provide scientific leadership within Preclinical Safety, particularly with experience in the conduct and interpretation of reproductive and developmental toxicity studies and data (preferred)
Provide internal expertise for global nonclinical safety issues on various expert groups or internal committees as required. Prepare scientific publications and presentations from toxicology and safety pharmacology studies as appropriate
Participate in special projects or inter-industry working groups, as needed
Provide scientific input on design and analysis of R&D activities, including evaluations of external opportunities for in-licensing, and ensure activities are completed with highest scientific standards
Qualification
Required
PhD or DVM with at least 12-15+ years related pharmaceutical industry experience
Knowledge in biochemistry, toxicology, pharmacology, biology, physiology, pathology, and statistics
Knowledgeable and experienced regarding GLP and ICH policies, regulatory nonclinical testing requirements
Writing documents for regulatory submission and interactions with health authorities
Experienced in IND and CTD submissions
Preferred
Experience in the conduct and interpretation of cell and gene therapy studies and data
Experience as a GLP Study Director
Certification by the American Board of Toxicology
Benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Company
Sanofi
Sanofi is a global biopharma company focused on prescription drugs, vaccines, and treatments for chronic, rare, and infectious diseases.
10001+ employees
H1B Sponsorship
Sanofi has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (101)
2024 (68)
2023 (59)
2022 (78)
2021 (38)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$6.97BKey Investors
Blackstone Life SciencesEvotec
2025-10-28Post Ipo Debt· $3B
2025-06-17Post Ipo Debt· $1.74B
2025-03-05Post Ipo Debt· $1.59B
Leadership Team
Paul Hudson
Chief Executive Officer
Francois-Xavier Roger
Chief Financial Officer
Recent News
2026-01-25
BioWorld Financial Watch
2026-01-25
2026-01-24
Company data provided by crunchbase