Distinguished Scientist, Safety Assessment Project Expert

Sanofi • Cambridge, MA

21d • Hybrid

About The Position

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. The candidate will be part of a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a member of global project teams. Given the activities performed by the group, internal (within Preclinical Safety and with other project functions) and external (collaboration partners) interactions occur on a daily basis making for a diverse work environment. You will Be exposed to all aspects of the drug development chain Have diverse opportunities to provide toxicology scientific input and apply those expertise Be recognized by Management and Project Teams for successes Receive excellent benefits and compensation. As an overview, the incumbent will be responsible for oversight of the nonclinical safety program of Research and Development drug candidates. These activities entail formulating the nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, interacting with internal and external partners, and interacting with and responding to global regulatory agencies. In addition, you will review compounds for potential in-licensing opportunities and address nonclinical safety issues/risks for marketed products as other activities. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

• 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 desired.

Nice To Haves

• experience as a GLP Study Director.
• Certification by the American Board of Toxicology is preferred but not required.
• Experience in the conduct and interpretation of cell and gene therapy studies and data is preferred but not required.
• Provide scientific leadership within Preclinical Safety, particularly with experience in the conduct and interpretation of reproductive and developmental toxicity studies and data (preferred).

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.

Benefits

• Receive excellent benefits and compensation.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree