David Croteau Email and Phone Number

Work directly with the Chief Medical Officer in managing both corporate- and project-related activitiesResponsible for all project level clinical research and development functions, and advise on medical matter on a global basisWork directly with project level staff to develop appropriate pharmacovigilance documents and project plansResponsible for developing plans to ensure programs meet quality and safety standards required by medical and regulatory agenciesResponsible for clinical development, including providing leadership to regulatory and medical affairs, and data management Provide consultative guidance on medical matters to leaders across the company and with outside health/medical and regulatory organizations

Attend the Hillcrest Medical Center Neurology Service 4 weeks a yearAttend the Hillcrest Medical Center Neurology Residents Continuity weekly clinicAttend the Hillcrest Medical Center HIV Neurology, Urgent Neurology and General Neurology ClinicsConceptualize, plan, organize, direct and administer clinical research projects in HIV Neurology under the HIV Neurobehavioral Research Center (HNRC)Medical students and residents teaching:UCSD Neurology Residency Program, didactic sessions lecturer 2009-2010UCSD School of Medicine, small group leader (Basic Neurology – Y1) 2010UCSD School of Medicine, laboratory instructer (Mind, Brain & Behavior – Y1) 2011UCSD School of Medicine, clinical instructor (Intro to Clinical Medicine – Y2) 2010-2011UCSD School of Medicine, small group leader (Mind, Brain & Behavior – Y2) 2012

1) Provide medical input to protocol elaboration and design, regulatory documents and clinical operations for IL13-PE38QQR, liposomal encapsulated paclitaxel and liposomal encapsulated docetaxel projectsSupervise pharmacovigilance aspects of studies above including IND adverse events, SADRs, and SUSARs narrative generation, additional data collection, causality, severity (using CTC) and clinical significance evaluation, adverse event MedDRA coding, expedited reporting to regulatory agencies, IND annual safety reports write-up, and safety signal analyses2) Medical and clinical trial consulting on products and product acquisition candidates3)Provide medical input and writing of pre-clinical studies for intracerebral CED liposomal topotecan projects4)Provide medical input to protocol elaboration and design, regulatory documents, clinical operations, and biostatistics/programming for vigabatrin projects

Responsible for medical oversee of clinical trialsResponsible for protocol elaboration and design (Phase 1-3)Prepare and/or provide medical input to clinical study reports, investigator brochures, manuscripts and other scientific or regulatory documentsInitially provided medical input to pharmacovigilance team but subsequently directed the pharmacovigilance team including input on IND adverse events, SADRs, and SUSARs causality and clinical significance evaluation, adverse event coding, expedited reporting to regulatory agencies and IND annual safety reportsProvide medical input to strategic planning, clinical operations, biostatistics/programming, pharmacokinetics and translational medicineInterface with current and prospective investigators from various specialties (neurosurgery, medical oncology, neurology, pediatric oncology) for strategic planningProvide neuro-oncology, neurology and CNS convection-enhanced delivery technique medical and scientific expertise