Carrie Guss

Carrie is an energetic and quality-conscious drug developer with an eye for detail and over 25 years of experience leading teams for the largest and smallest companies. She has extensive experience planning and executing Phase 1-4 clinical trials through study reporting and submission, including rescue of projects outsourced to CROs for many clients. Carrie has established and led high-functioning R&D departments from the ground up, bringing several drugs to market from study start through the compiling, review and submissions of NDAs, ANDAs, EUAs and other filings. She is skilled in clinical operations, cross-functional leadership, study management and monitoring, vendor selection, management and oversight, contract and budget negotiations, clinical data review, inspection readiness, and review of regulatory submissions. Carrie has served on medical, regulatory, and legal review boards to ensure corporate compliance of promotional material. She has participated in numerous regulatory meetings in the US, Canada, China and Europe. Her therapeutic experience includes Oncology, cardiovascular, metabolism, pain and inflammation, dermatology, women’s health, pediatrics, and nephrology- both dialysis and non-dialysis.