1. Experience leading a scientific organization within government, industry, or academia. I am a supervisory branch chief in the Division of Nonclinical Science (DNCS), Office of Science (OS) with over three years of experience. I provide scientific expertise and oversight for tobacco product review, regulation, and research. I have also served on details as the Deputy Division Director and the Deputy Office Director, guiding the Division and the Office in the development of scientific evidence to support Center for Tobacco Products (CTP) policies and mission.
2. Extensive knowledge of tobacco product regulations, policy and research. Since 2010 I have developed scientific evidence for tobacco product regulations, such as product standards, policies, and supported decisions in tobacco product application reviews. I have provided support for process development in tobacco regulatory pathways, as well as multiple levels of scientific review for hundreds of substantial equivalence (SE) Reports, and review of several investigational tobacco products. I have worked with other DNCS managers to develop and …show more content…
Broad familiarity with diverse, cutting-edge scientific technologies used in regulatory science labs. I have identified regulatory science needs and collaborated with other FDA Centers to perform research specific to CTP needs that utilize the latest technologies applicable to regulatory science. These include development and use of an inhalation core facility at NCTR, and contracted research using diverse scientific toxicology approaches in inhalation toxicology, computational modeling, high-throughput assays, and other technologies. My expertise in diverse scientific technologies has been critical when reviewing and prioritizing a broad range of NIH grant applications that address tobacco regulatory science research needs, and this expertise provides the ability to identify areas of interdisciplinary collaboration both within CTP and across FDA
2. Extensive knowledge of tobacco product regulations, policy and research. Since 2010 I have developed scientific evidence for tobacco product regulations, such as product standards, policies, and supported decisions in tobacco product application reviews. I have provided support for process development in tobacco regulatory pathways, as well as multiple levels of scientific review for hundreds of substantial equivalence (SE) Reports, and review of several investigational tobacco products. I have worked with other DNCS managers to develop and …show more content…
Broad familiarity with diverse, cutting-edge scientific technologies used in regulatory science labs. I have identified regulatory science needs and collaborated with other FDA Centers to perform research specific to CTP needs that utilize the latest technologies applicable to regulatory science. These include development and use of an inhalation core facility at NCTR, and contracted research using diverse scientific toxicology approaches in inhalation toxicology, computational modeling, high-throughput assays, and other technologies. My expertise in diverse scientific technologies has been critical when reviewing and prioritizing a broad range of NIH grant applications that address tobacco regulatory science research needs, and this expertise provides the ability to identify areas of interdisciplinary collaboration both within CTP and across FDA