HEAD of clinical operations
Bernice (Bernie) Kuca joined Tremeau Pharmaceuticals in 2019.
Bernie brings over thirty years experience in the pharmaceutical/biotech industry in various Clinical Operations, Clinical Project Management, and Regulatory Strategy and Operations roles. Her therapeutic experience includes CNS, oncology, antihistamines, and anti-infectives.
Bernie was most recently was the Head of Clinical and Regulatory Operations at CoLucid, which was acquired by Eli Lilly in 2017. Previously at Genetics Institute, Praecis, and Sepracor, she was a key clinical contributor on products going from INDs to successful NDAs.
Bernie has led multi-site, multi-country studies, completing them on time and on budget, and has presented at industry sponsored conferences on managing relationships with CROs. Known for being the clinical project manager on Sepracor’s sleep medicine, Lunesta®, she provided leadership and management of 4 project teams within a CRO as well as multiple vendors, initiating and completing 25 studies (Phase 1 to Phase 3) in 3 years, and filing a successful NDA.
At Oscient, Bernie led clinical operations and oversaw a post-NDA required Phase 4 study and a multi-country Phase 3B study, contributing to an SNDA.
Bernie has a Bachelor’s degree in Biology from the State University of New York at Buffalo, a Master’s of Science in Applied Anatomy and Physiology from Boston University, and a Graduate Certificate of Special Studies in Administration and Management from Harvard University Extension School.
Bernie serves on the Board of Directors and Executive Committee of Can Do MS, a national non-profit.