Responsibilities Include:- Responsible for safety support of global Vicks respiratory brand; and have also supported Pepto-bismol, Prilosec, PUR water filtration, and Metamucil.- Review protocols and study reports, prepare toxicology sections for global regulatory submissions (including FDA IND/NDAs, global dossiers), internal project summaries and reviews with management.- Interface with global regulatory agencies (US FDA, Latin America, Western and Eastern Europe, China, and India) for safety-related support (via written communications, phone conversations, and face-to-face meetings).- Prepare safety strategy and program guidance across diverse projects/products (e.g., OTC drugs, herbal/dietary supplements, foods, water filtration, and medical devices). - Design, conduct and interpret data from toxicology studies across endpoints (acute, sub-chronic, chronic, safety pharmacology, developmental and reproductive and metabolism (in vitro and in vivo) and PK studies.- Perform safety and/or quantitative risk assessments on raw materials, formulations, impurities/degradants, and finished products.- Interface with external suppliers and contract manufacturers for safety related data on raw materials.- Internal Company Expert team member to provide ADME support across all business units and consultation on animal alternatives (e.g., in vitro metabolism, PB/PK modeling, in vitro skin penetration).- Coordinate ADME and PB/PK modeling support to refine quantitative risk assessments as needed for Personal Health Care business.- Single point of contact for California Proposition 65 compliance of all PHC products.- Represent P&G as safety contact for impurity and degradant discussion groups via CHPA and USP.- Provide technical mentorship and oversight to junior toxicologists and ADME scientists in organization (includes outlining training and projects to gain experience).- Assess product labels and advertising materials for regulatory compliance.

- Lecture in general toxicology, hepatotoxicity and kidney toxicology for Survey of Toxicology Course- Lecture in Pharmacokinetics for Environmental Genetics and Molecular Toxicology course- Lectures in general toxicology, hepatotoxicity, kidney toxicity, and pharmacokinetics for Industrial Toxicology course - Lectures in cardiac toxicology and organic solvents, Continuing Education for Industrial Hygienists workshop- Consultant on Environmental Genetics for NIEHS Grant #ES12093-01, "Partnerships to Educate on Environmental/Genetic Issues"

- Responsible for developing non-clinical program strategies and overseeing GLP toxicology studies in support of regulatory-acceptable world wide drug development programs. Represent non-clinical safety in interactions with Regulatory Agencies.- Manage impurities in drug substance issues from non-clinical safety standpoint.- Interface with PhRMA, Regulatory Agencies and Industrial colleagues on Immunotoxicity and Genotoxicity Guidance documents and related issues.- Support P&G Pharmaceuticals technical due diligence through safety evaluation of preclinical and clinical phase drug in-licensing opportunities in Musculoskeletal/Inflammation, Gastrointestinal, and Women’s Health focus areas.- Managed Document Management group and Experimental Toxicology group including all aspects of career development and project assignments- Served as Global Project Leader of a multi-discipline cross-functional team in the bone focus area

Responsibilities included:- Provided all experimental and strategic support (study design, scheduling, timing, resource allocation, prepared DMPK sections on regulatory submissions) for all DMPK studies in support of project assignments (both Discovery and Development programs).- Served as Study Director/Study Monitor on all metabolism studies in support of project assignments.- DMPK single point of contact on all Stage 1 Discovery projects; managed experimental support, ensured DMPK scheduling, timing, and resourcing accurately reflected in all Stage 1 project plans as developed.- Reviewed early stage in-licensing opportunities from DMPK perspective.- Single point of contact for metabolism support across other Global Business Units throughout Procter & Gamble; provided review of metabolism issues, outside protocols, design and scheduling of internal metabolism support for outside Pharma projects within my laboratory.- Managed Metabolism group (4 to 9 employees over 6+ years) including hiring personnel (PhD and BS/MS levels) and all aspects of career development and project assignments.