Kate Sharon, M.S., Ph.D
Indianapolis,IN
Summary
Senior Research Scientist with extensive experience directing clinical trials and authoring protocols across multiple therapeutic areas. Efficacy leader of FDA submissions, driving regulatory approvals and label-claim strategy. Expertise in statistics, and data-driven go/no-go decision frameworks. Skilled at building trusted investigator relationships and influencing cross-functional teams to deliver strategic clinical outcomes.
Overview
9
9
years of professional experience
Work History
Senior Research Scientist
Elanco
10.2023 - Current
- Clinical Lead on asset with potential blockbuster designation; managed $10M+ development budget.
- Oversaw development programs across multiple therapeutic areas including immunology, metabolism, endocrinology, and nutrition.
- Led 10+ global GCP studies across Europe, Mexico and New Zealand in both university and CRO settings ensuring regulatory adherence.
- Led the efficacy program in new regulatory approval pathway achieving regulatory approval in
- Authored 20+ clinical protocols supporting early-phase through registration, including first-in-class program.
- Regulatory liaison for multiple projects; led 3 FDA efficacy submissions and 2 narrative dossiers.
- Budget accountability: Designed go/no-go study saving $500K and 3 months; portfolio decision freed $1M+ capital.
- Clinical Development Lead for AI-enabled global development initiatives. Reduced timelines for submission preparation including. Drove new initiatives for AI applications to increase productivity.
Research Scientist - Statistics
Elanco
08.2019 - 10.2023
- Extensive experience with SAS and familiarity with regulatory requirements for data management, analysis, and submission documents.
- Served as statistician for data analysis for multiple projects including exploratory and submissions.
- Statistical QC for EFSA product renewal and authored H submission.
- Created predictive tool for project cost and timing estimations entering Development, accelerating feasibility assessments and increased quarterly operational efficiency savings by an estimated $70k.
Postdoctoral Researcher
Elanco
07.2017 - 08.2019
- Research position in Statistics developing new assays for pain in companion animals resulting in two first-author publications in Animals and American Journal of Veterinary Research.
- Extensive experience in R and SAS.
- Postdoctoral Council Leader Elanco/Eli Lilly resulted in collaboration between multiple disciplines. Fostered inclusive culture across program.
Education
Ph.D. - Nutritional Immunology
Texas Tech University
Lubbock, TX07-2016
Master of Science - Animal Science
Montana State University
Bozeman, MT05-2013
Bachelor of Science - Organsimal Biology
Montana State University
Bozeman, MT05-2011
Skills
- Clinical Development Strategy and Trial Design
- Protocol Authoring and Study Leadership (20 Protocols)
- FDA Regulatory Liaison and Efficacy Submissions (3)
- Statistical and Analytical Expertise (R, SAS, Postdoctoral Training)
- Go/No-Go Decision Frameworks and Portfolio Optimization
- Highly Engaged and Collaborative
Timeline
Senior Research Scientist
Elanco
10.2023 - Current
Research Scientist - Statistics
Elanco
08.2019 - 10.2023
Postdoctoral Researcher
Elanco
07.2017 - 08.2019
Ph.D. - Nutritional Immunology
Texas Tech University
Master of Science - Animal Science
Montana State University
Bachelor of Science - Organsimal Biology
Montana State University