Charlotte Dubé, Ph.D. Email & Phone Number

PhD in sciences.Project and team management.Highly efficient, quality and detail-oriented with strong ability working both independently and collaboratively in a team environment or with external stakeholders.Strong organizational and communication skills.Ability to work in high stress contexts with tight deadlines.I have worked for over 17 years in the research and biopharmaceutical industry, including 6 years in a clinical CRO (bioequivalence) and 11 years in the preclinical department of biotech companies developing vaccines against infectious diseases and cancer. I started as a PK scientist in the scientific and regulatory department of a clinical CRO. I was responsible for the analyses, interpretation and reporting of PK clinical data. My work also included interactions with clients and participation to audits and inspections. In 2013, I moved to the preclinical field in vaccine biotech companies in which I had the chance to be part of the preclinical development of several products from R&D to regulatory submissions and approval by different regulatory agencies. These experiences have enabled me to acquire a strong expertise in product development and related activities conducted in support to the clinical development of prophylactic and therapeutic vaccines. Over the years, I have been involved in the study design development, planning, execution and oversight of more than 200 preclinical studies (non-GLP/GLP, early/late stage) conducted at CROs or academic institutions. I have a deep knowledge in required study-related documentation, scientific data analyses, interpretation and presentations; a strong experience with CROs (selection/audit/agreement establishment/quality oversight) and a very good understanding of the GLP regulations. My activities also included planning project budget and financial monitoring of the studies. I have developed my skills in the nonclinical regulatory field with active participation in writing regulatory documents (CTA, NDS, BLA, IB, DSUR, SDSP, product monograph, CMC), preparing answers to questions from authorities for Phase 1, 2 and 3 clinical studies or commercial license applications, including interactions with regulators. Part of the product approval process, I have worked on the preparation for the pre-approval inspections for a commercial license. I have additionally been deeply involved in the establishment of a procedural framework to support the operational infrastructure of a business sector (preclinical), implementation of quality standards, training of members, mentorship.