Denis Roy

WORK HISTORY

EDUCATION

SKILLS

ABOUT DENIS ROY

Bilingual nonclinical research and integrated drug development leader with over 25 years of experience in pharmaceutical, biotechnology, consulting, and CROs industries. Creative, service-oriented and respected leader in staff management, development and oversight, in addition to recognized leadership and management effectiveness in small and large working environments. Tailored solution-oriented senior regulatory toxicologist with recognized expertise and experience in developing strategic nonclinical programs for drugs, biologics, and medical devices for diverse therapeutic areas including endocrine/metabolism, oncology, pulmonary, CNS/neurology, cardio-renal, GI, ophthalmic, vaccine, anti-infective/allergy, dermal, ocular, and reproductive health products. Seasoned toxicology expert with successful representation at meetings with FDA and TPD, and expert committees in addition to preparation and review of multiple international pre-meeting, IND/CTA/IDE, pre-marketing and marketing submissions. Experienced toxicologist with Study Director and Study Monitor experience and expertise for the outsourcing and conduct of GLP-compliant nonclinical safety studies in all species. Extensive technical experience in safety testing including animal reproductive and inhalation toxicology, drug delivery technologies, surgeries, clinical pathology, pharmacokinetic/toxicokinetic, GLP compliance, in addition to laboratory and vivarium management and animal welfare. Designed and conducted several studies using small molecules, devices, monoclonal antibodies (MAb), peptides, proteins, conjugates, blood products, vaccines, gene therapy technologies, oligonucleotides, and combination products. Recognized leadership and expertise in addressing nonclinical safety study findings or technical issues and their clinical, regulatory, strategic and corporate impacts on the overall development program.