Have designed/written numerous clinical & preclinical study protocols, development plans to take products to market approval, clinical study reports, manuscripts, consent forms, product labels, Investigator Brochures, Target Product Profiles, Risk Management Plans, Audit Plans, Monitoring Plans and data collection tools (IVRS, paper, EDC) in all phases of drug & device development. Have reviewed reams of data & statistical tables, drafted abstracts/poster presentations and full manuscripts, contributed to stat analysis plans and performed summary statistics, power and sample size calculations. Have reviewed data across multiple studies (totaling over 30k patient records) to identify potential safety concerns and verify treatment eligibility. Have managed cross-functional teams, single-center Phase I through mega-trial Phase IV studies with 300 centers/5000 patients and study budgets from $300k - $12M; have put together complete clinical development programs and program budgets >$100M. Have selected and managed CROs, CRAs, CMOs, clinical and analytical labs, Data Safety Monitoring Boards and Medical/Scientific Advisory Boards. Have set up clinical departments, including all supporting infrastructure (SOPs, hiring). Have authored several 510(k)s and, with development teams, INDs and NDAs. Have contributed to the content of numerous patents, done in-depth IP/patent searches and evaluations and due diligence activities. Have worked on formulation issues, secured suppliers and put in place manufacturing and supply chain agreements. Have set up pharmacovigilance systems and processes, evaluated numerous unsolicited research proposals for scientific merit and potential partnerships. Authorized Representative for three pharma companies. Majority of experience has been in analgesia (IV opioids for intra- & postop pain; induction agents), IV synthetic oxygen carriers to treat a variety of life-threatening ischemic/hypoxic conditions, CNS, HBV and traumatic brain injury.