Biologics Consulting is seeking to hire an expert regulatory toxicologist. The incumbent should have a PhD (preferably in pharmacology or toxicology) with at least 5 or more years of experience within industry or a national regulatory agency such as the Food and Drug Administration, as well as having experience with a broad base of products including small molecules, vaccines, mAbs, proteins, blood products, and with a particular emphasis on recent experience in cell and gene therapy products. Candidate should demonstrate excellent verbal and written communication skills.
This position involves working as a consultant directly with US and international biopharmaceutical companies and other product developers to advise them on the best pharmacology/toxicology approaches that will expedite moving their products into the clinic and through marketing authorization. Responsibilities include, but are not limited to, providing nonclinical strategic support, planning appropriate pharmacology-toxicology studies, interfacing with toxicology CROs, preparation for and participation in FDA meetings, evaluation of toxicology data, and reviewing and/or writing regulatory documents (INTERACT dossiers, pre-IND briefing packages, IND, BLA/NDA).