Jeremy Smith

• Over 25 years developing pre clinical investigational drug candidates according to FDA GLP guidelines. Managing the progression of candidates into clinical studies and ultimately product approval. Managed studies include a broad range of drug modalities, including small and large molecule, cell and gene therapies, mRNA, and other biologic's.
• Work directly with study directors and resource group staff in the planning, executing, and monitoring of study activities and budgets, as well as the personnel related to the study
• Ability to support multiple simultaneous projects (50+)
• Lead, direct, and manage day-to-day business operations to ensure the staff execute responsibilities and meet deadlines
• Manage scope, schedule, and budgets, identifying and recommending resolution on cost and schedule issues
• Serve as the client’s primary point of contact and facilitate ongoing communication for any client needs
• Coordinate meetings both internal and external and prepare necessary status reports to ensure project tasks are completed

Programs managed included the National Cancer Institute (NCI), National Toxicology Program (NTP), CBRN Medical (Chemical, Biological, Radiological and Nuclear) and many commercial clients

• Provide technical and managerial experience in conducting preclinical toxicology studies
• Oversee the development of protocols, study conduct, interpretation and evaluation of data generated, writing technical reports, and the delivery of final reports to clients
• Responsible for coordinating activities between technical centers, quality assurance, and clients
• Primary focus was in the preclinical testing of potential new drugs in different species and routes of administration
• Excellent working knowledge of the FDA’s Good Laboratory Practice regulations and Standard Operating Procedures

• Responsible for coordinating activities between technical centers
• Technical skills: dose formulation preparation, various species and routes of administration
• Strong background in kinetic evaluation, inhalation, safety pharmacology and toxicity studies

• Built, Designed and Operated Inhalation systems evaluating toxicity and respiratory function