Pharm/Tox Senior Consultant

Company: Biologics Consulting, Inc.
Location: Alexandria
Posted on: September 12, 2020

Job Description:

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).

Maryland Location

199 E. Montgomery Avenue, Suite 100 · Rockville, MD 20850

Phone: 240.599.8040 Get Directions

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Keywords: Biologics Consulting, Inc., Alexandria , Pharm/Tox Senior Consultant, Other , Alexandria, Virginia