Jeffrey Klein, Ph.D., DABT

Principal Consultant

Jeffrey Klein is a board-certified toxicologist with more than 20 years’ experience in the pharmaceutical industry.  Jeff has broad regulatory and scientific expertise across several therapies including small molecules, peptides, proteins (including vaccines and monoclonal antibodies), and medical devices.  His strengths include an ability to identify gaps in drug development programs and define and prosecute strategies to successfully enable clinical development and marketing activities.  In his former roles as Study Director and Director of Toxicology and Dermatology at a Contract Research Organization (CRO) as well as a Sponsor, Jeff successfully led nonclinical strategy and was a key contributor in multiple programs including investigational new drug applications (IND) as well as several marketing authorizations for both small molecules and medical devices.  He has broad therapeutic expertise including dermatology, oncology, neurology, and infectious diseases, and he is the Past President of the Dermal Specialty Section of the Society of Toxicology.  He has substantial experience in the preparation for and participation in regulatory authority meetings as the nonclinical representative.  Jeff has a Ph.D. in Animal Sciences from Rutgers University, and he is a Diplomate of the American Board of Toxicology (DABT).