Distinguished Scientist, Safety Assessment Project Expert

Sanofi

. Serve as a Preclinical Safety Project Team Member on multifunctional Research and Development Project Teams covering small molecules, biotherapeutics, oligonucleotides, and other modalities .

Posted 11/4/2026full-timeUnited StatesSeniorLead💰 $178,500 - $257,833 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in preclinical safety and toxicology, with a strong background in regulatory submissions and compliance. Proven ability to lead scientific initiatives and communicate complex data effectively to diverse stakeholders.

Highest-signal resume keywords

PhD Or DVM In Biochemistry12+ Years Pharmaceutical Industry ExperiencePreclinical Safety And Toxicology ExpertiseGLP And ICH Policies KnowledgeIND And CTD Submission Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Toxicology Strategies DevelopmentSafety Pharmacology ImplementationNonclinical Safety Activities SupportRegulatory Document PreparationScientific Publication PreparationOphthalmology Toxicity Study InterpretationData Presentation SkillsProject Team CollaborationRisk Assessment For Marketed ProductsScientific Leadership In Toxicology

Soft Skills

Exceptional Written CommunicationVerbal Communication SkillsPresentation SkillsInterpersonal Skills

Certifications & Qualifications

American Board Of Toxicology Certification

Industry Keywords

Drug DevelopmentNonclinical Testing RequirementsGLP Study Director ExperienceRegulatory Agencies InteractionLife Cycle Management

About the role

Key responsibilities & impact

Serve as a Preclinical Safety Project Team Member on multifunctional Research and Development Project Teams covering small molecules, biotherapeutics, oligonucleotides, and other modalities
Support development of new products and develop and implement toxicology and safety pharmacology strategies
Support nonclinical safety activities for early- and 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
Assist other Project Team Members with regulatory activities as needed
Review reports and documentation from internal personnel and external contract laboratories
Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies
Provide scientific leadership within Preclinical Safety, particularly regarding reproductive and developmental toxicity studies and data
Provide internal expertise on global nonclinical safety issues through expert groups or internal committees
Prepare scientific publications and presentations from toxicology and safety pharmacology studies
Participate in special projects or inter-industry working groups
Provide scientific input on R&D activity design and analysis, including evaluations of external in-licensing opportunities
Address nonclinical safety issues and risks for marketed products
Interact with internal and external partners and global regulatory agencies

Requirements

What you’ll need

PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or closely related field
12+ years of pharmaceutical industry experience in drug development
Demonstrated experience in preclinical safety and toxicology
Demonstrated knowledge and experience regarding GLP and ICH policies
Understanding of regulatory nonclinical testing requirements
Demonstrated experience in preparing and submitting IND and CTD submissions
Exceptional written and verbal communication and presentation skills
Ability to present preclinical safety data in a project team setting and/or HA interactions
Experience as a GLP Study Director and/or Study Monitor (preferred)
Experience in the conduct and interpretation of ophthalmology toxicity studies and data
Certification by the American Board of Toxicology is preferred but not required

Benefits

Comp & perks

Excellent benefits and compensation
Opportunities to grow talent and drive career through promotion or lateral moves, at home or internationally
Thoughtful rewards package recognizing contribution and amplifying impact
High-quality healthcare
Prevention and wellness programs
At least 14 weeks' gender-neutral parental leave