• Responsible for providing strategic and technical advice to clients, especially with regard to non-clinical development strategy and marketing authorization submissions.• Regulatory and Product Development Strategy, Non-Clinical Development Planning, FDA (INTERACT, Pre-IND, IND, pre-NDA, pre-BLA, NDA, BLA), EMA and different European Agencies (pre-CTA, CTA, MAA), China NMPA/CDE and Health Canada (pre-CTA, CTA, MA), including joint regulatory agency meetings. Experience in non-clinical dossiers (IMPD/IB) for clinical trial applications including First-In-Human (FIH), Phase 2 and 3 trials, specifically driving non-clinical and regulatory strategy meetings with clients and regulatory Agencies.• Mentorship of junior staff for their understanding/training in regulatory Guidelines for US FDA.

• Provide non-clinical and regulatory expertise to innovatively and strategically optimize product development programs and interactions with Regulatory Agencies. Act as a trusted advisor to clients, providing regulatory solutions to address specific client needs.• Provide subject matter expertise, including clinical pharmacology input, into investigational and marketing applications, Investigator Brochures, pediatric study plans, scientific advice meeting materials, and other regulatory submissions. • Input is provided at all stages of drug development supporting various disciplines with integrated clinical and regulatory knowledge.• Serve as Project Leader for select project types, providing overall project leadership and project planning, and ensuring that the project team delivers to meet the client expectations for quality and timeliness.

ITR (International Toxicology Research) Laboratories Canada, a contract research organization (CRO) located in Montreal, Quebec is a global service provider with over 30 years of experience. Every program is different and every project requires a well thought out solution to ensure success. We take the lead in providing specialized services in efficacy, toxicology and laboratory services for all types of molecules and we believe in creating a working partnership with our clients to attain our objective. Our preclinical research programs are conducted in our state-of-the-art facility by a team of experienced and well-trained technicians and scientists to help maximize the value of your research investment.• Line-management experience with supervisory and training responsibilities for a number of Study Directors.• Involvement in interactions with Sponsors (including discussions on study/program design and regulatory concerns), in-house committees and task-forces, and marketing events. • Deputize for the Vice President, Sciences. • Responsible for the planning, conduct and evaluation of pre-clinical safety studies/programs for the pharmaceutical industry, including preparation of study plan, coordination and monitoring of study/program progress, scientific review of data, evaluation of results and report preparation.• Chairman of the Health & Safety, and Biosafety Committees

Canadian biopharmaceutical company committed to the discovery and development of novel cell and gene therapies to extend and enhance the quality of the lives of people suffering from chronic life-threatening pulmonary disorders. • Project management of Phase 2 in Pulmonary Arterial Hypertension (PAH) and clinical sites including interactions with investigators and KOLs as to relation maintenance and promotion of patient difficult and rare patient population recruitment. • CRF data entry verification as to ensure accuracy of data• Organize and monitor clinical, logistical and manufacturing CRO performances including completeness and adherence to project cost estimates.

• Project management of clinical and nonclinical studies for FDA and Health Canada medicinal products in multiple therapeutic disease areas including Dermatology, CNS, Pain, Cardiovascular, Endocrinology and Cannabis-related indications. • Medical writing of clinical study protocols, investigative brochures (IBs), statistical analysis plans (SAPs), and case report forms (CRFs). • Strategic planning for drug development programs of medicinal or natural health products.• Quality control of clinical and toxicological study reports.• Regulatory filing of CTA and IND for medicinal/natural health products.

• Directed global scientific activities from clinical to nonclinical affairs, and regulatory affairs.• Developed and maintained relationships with Key Opinion Leaders (KOLs) and healthcare providers (HCPs) to maximize acceptance and ensure proper utilization of products and science as well as patient recruitment strategies for multicentric, multinational and multi-regional Phase 1-4 clinical trials.• Line management of R&D staff including internal and externally-resourced consultants as well as set budgets and timelines in conjunction with executive management.• Onsite scientific training of medical staff/investigators as to develop their medical knowledge.• Ensured scientific quality and risk management of products.

• Designed strategy and managed completely GLP and non-GLP nonclinical program on investigational products, including writing/reviewing of all nonclinical and toxicological scientific reports for CTAs, INDs, and NDAs.• Improved patient recruitment by innovative recruiting strategies and use of KOLs.• Involved in GCP clinical trials: protocol writing and reviews, investigator brochures and investigator recruitment.• Sponsor representative for all nonclinical studies conducted by animal CROs.• Setup, and managed staff and operations of internal vivarium for non-GLP studies.• Identified and recruited investigators for company sponsored clinical studies.• Organized and monitored clinical CRO performance including contract negotiations. • Managed departmental operations including budgets, staffing, and scientific studies.• Managed and oversaw the set-up and maintenance of regulatory documents.• Participated in international congresses and analyzed datasets for clinical trial abstracts.

• Clinical study management of two Phase II studies: recruitment strategies, SAE reporting, project management, primary Sponsor contact for clinical sites and Clinical CRO.• Oversight of Phase I, PK Study with other clinical scientists. • Interactions with internationally recognized and renowned key opinion leaders (KOLs) and Health Care Professionals (HCP) for Scientific Advisory Board.

• Supervised all GLP and non-GLP nonclinical research conducted in in-house laboratory, and external GLP-certified animal and analytical CROs required for IND, Phase 3 supporting studies and NDA. • Knowledgeable in efficacy using cardiometabolic animal models (ApoE, LDLr-/-, ZDF, JCR).

• Scientist involved in the identification of novel drug targets for multiple cardiovascular diseases.• In-depth understanding of in drug development, including commercialization and regulatory aspects.

• Planning of studies and Supervision of students (MSc and PhD), post-doctoral fellows (PhD and MD);• Participation as scientist in Phase IV clinical trials. • Managed all aspects of laboratory: personnel (hiring and reviews), budgetary, technician schedules; • Panning of studies and Supervision of students (MSc and PhD), post-doctoral fellows (PhD and MD).• Translational research studies: from bench to bed and back to bench. • Presentations at National and International scientific conferences;• Authored 22 scientific publications [3 primary, 9 secondary, 6 tertiary], 63 abstracts and 1 book chapter.