About the position
Are you ready to shape the future of medicine with us? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our safety team as a toxicologist and you'll assure the safety, quality, purity and stability of Sanofi components and products, while enjoying lots of opportunities to broaden your experience and hone your skills. 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, and receive excellent benefits and compensation.
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.
- Review reports and other documentation authored by internal personnel and/or external contract laboratories.
- 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.
- Provide internal expertise for global nonclinical safety issues on various 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 as needed.
- Provide scientific input on design and analysis of R&D activities, including evaluations of external opportunities for in-licensing.
Requirements
- 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.
- Experience in the conduct and interpretation of reproductive and developmental toxicity studies and data is desired but not required.
- Knowledge in biochemistry, toxicology, pharmacology, biology, physiology, pathology, and statistics.
- At least 12+ years related pharmaceutical industry experience.
Nice-to-haves
- Experience as a GLP Study Director.
- Certification by the American Board of Toxicology is preferred but not required.
- Excellent presentation and writing skills.
Benefits
- High-quality healthcare.
- Prevention and wellness programs.
- At least 14 weeks' gender-neutral parental leave.
