About Kathryn G. Davis
With an extensive background in clinical drug development, Kathryn Davis has experience working with
large pharmaceutical corporations as well as smaller biotech companies.
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 Research Center, 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.
With an extensive background in clinical drug development, Kathryn Davis has experience working with
large pharmaceutical corporations as well as smaller biotech companies. Wide range of experience
Kathryn's varied experience includes the management of global clinical trials in small molecules, biologics, vaccines, as well as the environment such as small to medium biotech and large pharma. 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 Research Center, 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.
Professional Associations
Kathryn has been a member of Healthcare Businesswomen's Association (HBA), Women Entrepreneurs in Science and Technology (WEST), Drug Information Association (DIA) and Society of Professional Consultants.Community Service
In the past, Kathryn has volunteered at the St. Matthew's Food Pantry, Dorchester, Mass. and the Breast Care Center at Winchester (MA.) Hospital. She served on the Board of Directors at the Community Day Center of Waltham , Mass., and The Society of Professional Consultants, on the Marketing Committee for HBA and markets Life Science events for the MIT Enterprise forum Cambridge, and the Board of Directors of the Cambridge Family and Children Services, a non-profit foster care and adoption agency in Cambridge, Mass.Personal
A fitness enthusiast, Kathryn also enjoys traveling, reading, collecting tea pots and scrapbooking.
Recent Consulting Assignments
- Novavax
- Kintor
- Seqirus
- Radius Health
- Merck
- Sanofi
- Sunovion
Positions Held
- Consultant -- Clinial Operations
- Director of Clinical Operations, Wyeth, Cambridge site
- Head of Clinical Operations, Wyeth, Cambridge site
- Associate Director of Research & Development, Wyeth
- Director of Clinical Operations, Wyeth
- Head of Clinical Operations, Therion Biologics
- Head of Clinical Operations, ArQule Inc