Senior Preclinical Safety Scientist (Toxicology)

Sanofi

Cambridge (MA)

On-site

USD 179,000 - 258,000

Full time

14 days+

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Job summary

Sanofi invites a seasoned toxicology professional to lead nonclinical safety programs for R&D candidates. You will design safety pharmacology and toxicology strategies, author regulatory documents, and collaborate with global project teams to advance drug development.

The role requires a PhD or DVM with 12+ years in pharmaceutical safety, GLP/ICH expertise, and IND/CTD submissions. You will review data, provide scientific leadership, and contribute to lifecycle management and regulatory

Qualifications

PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field, with 12+ years of pharmaceutical industry experience.
Demonstrated knowledge and experience regarding GLP and ICH policies and understanding of regulatory nonclinical testing requirements.
Demonstrated experience in preparing and submitting IND and CTD submissions.

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.