A highly experienced Drug Development Scientist with 25 years experience in nonclinical drug safety and nonclinical regulatory for small molecules and biotherapeutics at GlaxosmithKline and Pfizer. Expertise in nonclinical project lead roles with oversight of nonclinical drug safety plans, regulatory strategy, toxicology study design and conduct for multiple therapy areas: respiratory, antiviral, genitourinary, anti-malarial, topical, CNS, chronic kidney disease and regenerative medicine projects. Preparation of non clinical components of regulatory documents for Investigator Brochures, IMPDs, INDs, MAAs, NDAs.
Nonclinical Drug Safety Lead/Regulatory Strategy: Nonclinical lead for respiratory & oral projects for Asthma & COPD, genitourinary, anti-viral, anti-malarial, CNS, topical, chronic kidney disease and regenerative medicine projects. Maintaining oversight of nonclinical project safety plans and regulatory strategy including significant experience in preparation of regulatory nonclinical components of documents for regulatory submissions and responses to regulatory queries.
Toxicology Study Management: Highly competent Study Director & Study Monitor for a wide range of inhalation and general toxicology GLP studies by all routes for a variety of rodent and non-rodent species from short term to carcinogenicity. Significant experience of contract organisations specialising in inhaled and general toxicity studies in the UK, EU and US and associated budgets.