Professional Profile
Dr. Thomas Monticello is a Senior Consultant in ToxStrategies’ Pharmaceuticals practice. He has been a nonclinical safety sciences management and scientific toxicology/pathology translational safety leader for over 30 years. His experience includes work at major global pharmaceutical companies in diverse therapeutic areas for small and large molecules and novel modalities. His regulatory toxicology expertise encompasses interactions with health authorities at all stages of development, and particularly with investigational new drug (IND), new drug (NDA), and biologics license (BLA) applications.
Dr. Monticello has driven change in business practice by completing the Executive Black Belt and by implementing corporate initiatives to deliver savings and provide innovative approaches to expedite drug development and outsourcing opportunities. As a board-certified veterinary pathologist with expertise in nonclinical drug development, Dr. Monticello has contributed to the translational sciences field by serving as Past President of the Society of Toxicologic Pathology (STP), as a Board of Directors member for the International Consortium for Innovation and Quality in Pharmaceutical Research (IQ), and as past Chair of the IQ DruSafe Leadership Group, composed of senior nonclinical safety science leaders from over 30 biopharmaceutical companies. In addition, Dr. Monticello’s successful leadership of cross-functional teams has earned him a strong track record of recruiting, mentoring, and retaining key scientific talent.