Clinical Trial Manager

• Jul 2020 - Present

Scientist IV Biological Clinical Development

• Mar 2019 - Jul 2020

-Clinical lead for global vaccine projects

Group Leader Biological Clinical Development

• Aug 2015 - Mar 2019

Scientist III responsibilities plus manage Scientist II-III

Scientist III - Biological Clinical Development

• Mar 2012 - Aug 2015

Safety and Efficacy (S&E)-Plan and execute non-clinical and clinical studies required for global licensing of vaccines for livestock and companion animals.-Execute life cycle management studies requiring collaboration with Technical Services Veterinarians, Marketing, and Regulatory Affairs to determine objectives that would provide value to the end user and collaborate to mitigate potential risk.-Write protocols, interim and final reports and audit data.-Independently monitor study events to ensure protocol and regulatory compliance.-Train Study Investigators and routinely monitor progression of study activities at the study site.-Assist in outsourcing activities when appropriate, and liaise with Finance to monitor study budget and payables.-Train/mentor new employees and interns as needed. Show less

Supervisor CMC-Pharmaceutical Development Services

• Oct 2011 - Mar 2012

GMP Analytical Services-Manager of Study Coordination-Stability testing, method transfer, method validaiton

Associate Staff Scientist - Drug Metabolism

• Jul 2009 - Oct 2011

Pre-Clinical, Drug Metabolism and Pharmacokinetics (DMPK)-Study Director, GLP-Principle Investigator, GCP

Study Coordinator - CMC Pharmaceutical Development Services

• Sep 2006 - Jul 2009

GMP Analytical Services-Project management-Stability testing, method transfer, method validation

Study Techinician - Drug Metabolism

• Aug 2004 - Oct 2006

Pre-Clinical, Drug Metabolism and Pharmacokinetics (DMPK)-In-Vivo Research Associate-GLP, SOP, ADME, Toxicology