Senior Study Director performing GLP and non-GLP studies for gene therapy, drug, and medical device evaluation in the Surgery Services division. Special expertise in CNS delivery of gene therapy, oligonucleotides, and related compounds.

Created library of key scientific literature, federal regulations and guidance documents to support a variety of FDA and ISO10993 pharmaceutical, biological, medical device and combination product nonclinical testing programs. Generated training material and sample protocols for scientific staff to increase the breadth and depth of knowledge of various toxicological testing paradigms.

Worked as pharmacologist and toxicologist on multiple simultaneous cross-functional, highly collaborative translational research projects concerning direct delivery of drugs to the brain and spinal cord for pain and neurodegenerative diseases. Director for on-site and off-site in vivo and ex vivo biology laboratories. Study Sponsor or Study Director for safety and efficacy studies in rats, guinea pigs, rabbits, sheep, dogs and nonhuman primates. Provided toxicological guidance and design of custom nonclinical safety studies for small molecule, siRNA and biologics. Interacted with FDA on toxicological issues including CAPA investigations. Performed audits and due diligence investigations of potential partners and external laboratories. Created and delivered continuing education presentations to physicians in U.S. and Europe on spinal drug delivery and toxicology. Managed contracts and reports of external consultants. Initiated and co-organized a day long seminar on central drug delivery in large animal models at the Society for Neuroscience annual meeting

Supervised GLP-compliant dog laboratory functioning as a CRO that performed efficacy, pharmacokinetic and toxicology studies of drug delivery to the spinal cord. Developed protocols, performed studies, analyzed data, interpreted and reported results for multiple simultaneous contract studies initiated by industrial clients. Study Director for GLP toxicology studies in rodents. Supervised two to four research technicians. Co-Investigator of NIH funded RO1 grant to study opioid mediated intrathecal inflammatory mass formation in dogs. Managed multiple studies funded by industrial clients related to pain therapeutics. Assisted in teaching autocoid pharmacology cardiovascular animal laboratory. Director Molecular Biology Laboratory.