Nicole Bouvier
About Nicole Bouvier
Nicole Bouvier serves as the Director of Clinical Operations at Deciphera Pharmaceuticals, where she has worked since 2015. With a background in clinical research and a degree in Biomedical Laboratory and Clinical Sciences, she has played a key role in several pivotal clinical trials and regulatory inspections.
Work at Deciphera Pharmaceuticals
Nicole Bouvier has served as the Director of Clinical Operations at Deciphera Pharmaceuticals since 2015. In this role, she has been instrumental in overseeing clinical trials and ensuring compliance with regulatory standards. Bouvier successfully led Deciphera's first global Phase III pivotal trial, managing the process from protocol development to the NDA submission database lock. She has also initiated the company's first-in-human gastrointestinal stromal tumor trial and facilitated the transition of an ongoing Phase II trial to a new clinical operations team following a company acquisition.
Previous Experience in Clinical Research
Before joining Deciphera Pharmaceuticals, Nicole Bouvier held several positions in clinical research. She worked as a Clinical Research Associate at Ocular Therapeutix, Inc. from 2014 to 2015, and at Progenics Pharmaceuticals for six months in 2013. Additionally, she served as a Clinical Research Associate at New England Research Institutes, Inc. from 2013 to 2014. Her earlier experience includes a four-year tenure as a Research Technician at Massachusetts General Hospital, where she contributed to transplantation biology research.
Education and Expertise
Nicole Bouvier earned her Bachelor of Science degree in Biomedical Laboratory and Clinical Sciences from Boston University, where she studied from 2009 to 2011. Prior to that, she completed an Associate of Science degree in Veterinary Technology at the University of Maine, Augusta, from 2004 to 2006. Her educational background supports her expertise in clinical operations and research methodologies within the pharmaceutical industry.
Achievements in Clinical Trials
Throughout her career, Nicole Bouvier has achieved significant milestones in clinical trials. She hosted and presented at two Investigator Meetings in both the US and EU, showcasing her leadership in the field. Bouvier conducted comprehensive reviews and gap analyses of trial master files and pharmacovigilance files for due diligence meetings. She also participated as a clinical subject matter expert during an FDA BIMO inspection, demonstrating her knowledge and commitment to regulatory compliance.