Ensure regulatory requirements are met for all nonclinical reports, documents submitted to regulatory agencies (briefing documents, PBRERs, DSURs, etc.) and submissions that support clinical trials applications (INDs, IMPDs) and marketing applications (MAAs, CTD, NDA/BLAs). Other duties include:• Member of NCR Leadership Team• Written Reference Governance• Provide expert scientific and regulatory advice as nonclinical Subject Matter Expert: pediatrics; DART, SEND, ‘3Rs’, data… Show more Ensure regulatory requirements are met for all nonclinical reports, documents submitted to regulatory agencies (briefing documents, PBRERs, DSURs, etc.) and submissions that support clinical trials applications (INDs, IMPDs) and marketing applications (MAAs, CTD, NDA/BLAs). Other duties include:• Member of NCR Leadership Team• Written Reference Governance• Provide expert scientific and regulatory advice as nonclinical Subject Matter Expert: pediatrics; DART, SEND, ‘3Rs’, data integrity/data governance (DI/DG) initiatives.• Member of Pediatric Working Group, Genotoxic Risk Assessment Oversight Panel and Testicular Toxicity Panel• Internal presentations related to expertise and job functions. Show less

NCR Lead for Oncology Therapy Area and GSK Fellow

As a Pharm/tox reviewer, I:• Evaluated the nonclinical pharmacological and toxicological data contained in IND submissions, NDA/BLAs, Citizen’s Petitions and labeling submissions and prepared comprehensive written summaries and integrated conclusions• Provided solicited nonclinical scientific and regulatory guidance to sponsors during the development phase• Participated in industry meetings, filing, advisory, and labeling meetings• Provided expert nonclinical pharm/tox… Show more As a Pharm/tox reviewer, I:• Evaluated the nonclinical pharmacological and toxicological data contained in IND submissions, NDA/BLAs, Citizen’s Petitions and labeling submissions and prepared comprehensive written summaries and integrated conclusions• Provided solicited nonclinical scientific and regulatory guidance to sponsors during the development phase• Participated in industry meetings, filing, advisory, and labeling meetings• Provided expert nonclinical pharm/tox consultation as Agency resource for endocrine effects of sex steroids on the reproductive system• Received Center Director’s Special Citation (10/2011)• Received FDA Group Excellence Awards (6/2012 and 9/2012)• Trained Pharm/Tox reviewers in appropriate risk-based assessment of effects during pregnancy and on fertility using PLLR (2014)• Contributed to FDA draft guidances o Guidance for Industry: Nonclinical Evaluation of Endocrine Disruption Potentialo Guidance for Industry: Assessment of Male- Mediated Developmental Risk for Pharmaceuticalso Guidance for Industry: Testicular Toxicity: Evaluation during Drug Development• Member: o FDA Office of the Commissioner (OC) Bisphenol A (BPA) Joint Emerging Science Working Group, Chair of Reproductive and Development sub-groupo FDA OC Critical Path Initiate, Innovation in Development and Qualification of Alternative Testing Methodologies for Reproductive Toxicology Grant Evaluationo Interagency Coordinating Committee on the Validation of Alternative Methods, Endocrine Disruptor Working Groupo Developmental and Reproductive Toxicology PTCC Subcommittee o Computational Toxicology (QSAR) PTCC Subcommitteeo Coordinating Committee for Public Workshop on Alternative Testing to Eliminate the Second Species for Teratogenicity Testingo ILSI Health and Environmental Sciences Institute Developmental and Reproductive Toxicology Technical Committee• Collaborator/Consultant:o FDA Office of Women’s Health Grantso Chief Scientist’s Challenge Grants Show less