Senior Preclinical Safety Scientist

Sanofi; Morristown (NJ); On-site; USD 180,000 - 250,000; Full time

Benefits offered by this job

Competitive compensation

Excellent benefits package

Job summary

Sanofi US Services in Morristown, NJ, is seeking a senior Preclinical Safety Scientist to join a dynamic group providing toxicology and safety pharmacology expertise on global projects. You will collaborate with project teams across the drug development value chain to shape nonclinical strategies.

Responsibilities include leading nonclinical safety studies, writing summaries for regulatory documents, reviewing data, and contributing to publications.

Qualifications

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or closely related field with 12+ years pharmaceutical industry experience.
• Demonstrated knowledge of GLP and ICH regulatory nonclinical testing requirements.
• Experience preparing and submitting IND and CTD submissions.
• Exceptional written and verbal communication and presentation skills.

Responsibilities

• Serve as a Preclinical Safety Project Team Member on multi-functional R&D 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 and 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 reproductive and developmental toxicity studies.
• 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.

Skills

GLP & ICH knowledge

IND/CTD submissions

Toxicology leadership

Communication skills

Education

PhD or DVM

Job description

Sanofi US Services in Morristown, NJ, is seeking a senior Preclinical Safety Scientist to join a dynamic group providing toxicology and safety pharmacology expertise on global projects. You will collaborate with project teams across the drug development value chain to shape nonclinical strategies.

Responsibilities include leading nonclinical safety studies, writing summaries for regulatory documents, reviewing data, and contributing to publications.