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Bridgewater, NJ

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Job overview The incumbent will be responsible for oversight of the nonclinical safety program of Research and Development drug candidates primarily in the Development stage. These activities entail formulating the nonclinical safety strategies, designing toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, interacting with internal and external partners, and interactions with global regulatory agencies. Reviewing compounds for potential in-licensing and addressing nonclinical safety issues for marketed products is also an activity. Responsibilities Serve as a Preclinical Safety Project Team Member (PTM) on Research and Development Project Teams on small molecules and biotherapeutics. Support the development of new products, develop and implement toxicology and safety pharmacology strategies. Support needed nonclinical safety activities for marketed products. Write nonclinical summaries for clinical Investigator Brochures, INDs, CTAs and NDAs/BLAs, Pediatric Investigation Plans, and other regulatory documents and or assist other PTMs in such activities as needed. Review reports and other documentation authored by internal personnel (eg. 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. 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 research activities, including evaluations of external opportunities for in-licensing as appropriate, and ensure activities are completed with highest scientific standards. Minimum requirements: Knowledge in biochemistry, toxicology, pharmacology, biology, physiology, pathology and statistics PhD or DVM with 5 years of related experience.u00a0 Preferred qualifications: Knowledgeable and experienced regarding GLP policies and regulatory testing requirements.u00a0 Experienced in conducting and interpreting developmental and reproductive toxicology studies.u00a0 Good presentation and writing skills. Certification by the American Board of Toxicology is preferred.u00a0 Terms of employment Occasional travel to other Sanofi Research and Development sites (e.g Boston, Paris, Frankfurt) and to support regulatory meetings would occur in support of projects. Availability to start in Q3/4 2018. What makes this position unique? The candidate will be part of a dynamic interactive group that spans all aspects of the drug development process. 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. Benefits of working in this role The candidate will Be exposed to all aspects of the drug development chain Have diverse opportunities to provide scientific input and apply expertise Be recognized by Management and Project Teams for successes Receive excellent benefits and compensation Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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