With an extensive background in clinical drug development, Kathryn Davis has experience working with large pharmaceutical corporations as well as smaller biotech companies. Whatever the situation, she has been able to meet the established goals and objectives by creating a productive environment that combines her expertise with teamwork, understanding the “big picture” and collaboration.
Kathryn has served as Clinical Project Manager at Genetics Institute, Associate Director of Research & Development at Wyeth, Director of Clinical Operations at Wyeth and Assistant Vice President of Clinical Operations, Experimental Medicine at Wyeth; Kathryn 's career at Genetic Institute/Wyeth spanned 10 years. She was also instrumental in resourcing the Experimental Medicine Department, nurturing collaborative relationships, managing external vendors and leading projects that ultimately increased the profitability of the company. As a Senior Clinical Scientist at Bristol Myers Squibb in Wallingford, Conn. She played a major role in reviewing clinical data and assisting in developing an NDA submission package to the FDA.
More recently, Kathryn was Vice President of Clinical Operations, Clinical Department at ArQule, Inc., in Woburn, Mass., helping the company identify expert clinical consultants/contractors, initiating and closing down clinical studies, identifying clinical vendors who could streamline the drug development process by offering electronic solutions, working with the finance department to manage the clinical trial budget. Kathryn also completed several final clinical study reports.
Kathryn's consulting opportunities have been with Genzyme, a Sanofi Co., Sunovion Pharmaceuticals, A Global Central Laboratory and AVEO Pharmaceutical.
Wide range of experience
Kathryn’s varied experience includes the management of global clinical trials in small molecules, biologics and vaccines. Outside of the laboratory, she also has the ability to develop external business relationships and collaborations, providing guidance and leadership in vendor management, clinical document development, clinical data review and safety review. Kathryn has an excellent working knowledge of GCP/ ICH guidelines and has developed Standard Operating Procedures, as well as work guidelines.
Focusing on compliance and quality, she has a solid understanding of the clinical development process and the stages of development from Proof-of-Concept through Phase 4 including assisting in the filing of a BLA/NDA to the FDA.
Her passion has always been in the Life Sciences, both in pre-clinical and clinical drug development. Starting her pre-clinical work at Duke University, Kathryn continued to develop her skills at Becton Dickinson & Co., a biological research laboratory in Durham, N.C. After six years at Becton Dickinson, she accepted a Clinical Research Associate (CRA) position at Bristol Myers Squibb, eventually advancing to Senior Clinical Scientist.
Kathryn is a member of the Healthcare Businesswomen’s Association (HBA), Women Entrepreneurs in Science and Technology (WEST), Drug Information Association (DIA) and Society of Professional Consultants.
Kathryn currently volunteers at the St. Matthew's Food Pantry, Dorchester, Mass. and the Breast Care Center at Winchester (Mass.) Hospital. She serves on the Board of Directors at the Community Day Center of Waltham , Mass., The Society of Professional Consultants and is on the Marketing Committee for HBA and markets Life Science events for the MIT Enterprise forum Cambridge. In the past, she served on the Board of Directors of the Cambridge Family and Children Services, a non-profit foster care and adoption agency in Cambridge, Mass.
A fitness enthusiast, Kathryn also enjoys traveling, reading, collecting tea pots and scrapbooking.