Broad US/EU NDA, medical device and chemical company experience
Extensive experience in designing toxicology programs for US/EU NDAs and medical device submissions across a broad range of therapeutic areas, including the development of biomarkers to elucidate the mechanisms of drug toxicity
Extensive NDA team experience working with regulatory affairs, project management, biometrics, analytical chemistry, bioanalytical chemistry, manufacturing, marketing/claims support, and IP
Extensive experience in protocol design, GLP study initiation/management, monitoring of studies, data analysis, authorship of study reports and executive level NDA summaries (eCTD sections), and project leadership in support of a broad range of clinical efficacy, safety, and claims-support studies
Extensive due diligence experience in the evaluation of in-licensing pharmaceutical and medical device candidates across a broad range of therapeutic areas
Occupational toxicology experience in categorizing novel chemicals and process intermediates in control bands using in silico software such as DEREK, authoring assessments such as Occupational Exposure Limits, (OEL’s), evaluation of new Active Pharmaceutical Ingredients (API’s), and the conduct of risk assessments for contaminants in API batches
Excellent interpersonal and written/oral communication skills
Board-certified toxicologist since 1994
Over 25 years of experience working in Fortune 500 ethical pharmaceutical, medical device and consumer product companies:
