Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.
Our extensive research and development efforts address key health care challenges in cardiology, oncology, and internal medicine, as well as metabolic diseases and central nervous system disorders.
Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.
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Job Responsibilities/Department Description:
This position will provide Disposition, Safety and Animal Research Department (DSAR) a wide range of support associated with the Safety Pharmacology and Toxicology needs on Discovery and Development Project Teams for Sanofi Group (e.g. R&D, Genzyme, Pasteur) projects. This position would provide DSAR such scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules. Activities include, but are not limited to:
- Serve as DSAR Preclinical Safety Project Team Representative on multi-disciplinary Discovery and Development teams responsible for the progression of both small molecule and biotherapeutics compounds for regulatory submissions. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)
- Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, Pharmacovigilance, etc) on a daily basis
- Involved with the DART (Development and Reproductive Toxicology) Community of Practice group; includes the assessment of a test article’s reproductive effects and the design and conduct of investigative DART studies in support of the toxicological evaluation of compounds
- Participate in US-DSAR and global DSAR Department activities (staff meeting, scientific forums, etc), and special projects
- Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities
- Evaluate the safety excipients, impurities, extractable & leachables.
- Serve as internal expert for scientific issues related to nonclinical safety issues
- Ensure high scientific standards and adhering to requested timelines in all aspects of the position
- PhD or DVM and post-doctoral experience
- 3-6 years of relevant industry experience
- Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules
- Preparation of regulatory documents for submission to health authorities
The candidate should have knowledge in biochemistry, toxicology, pharmacology, biology, physiology, pathology and statistics. Experience in fetal evaluations (external, visceral, skeletal) is preferred. DABT certification is preferred, but not required. Experience as a GLP Study Director is preferred. This position is located in Bridgewater, NJ.
Job: Preclinical Drug Safety
Primary Location: United States - New Jersey - Bridgewater
Job Posting: June 10, 2015
Point of Contact: Bruce Beyer email@example.com
Apply Online: Toxicologist - Job Number 00246511-58590