Shari-Anne Burgess, RN, BScN

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Shari-Anne Burgess is the CEO and President of Clinsytes Inc., a specialized clinical consulting company she founded in July 2017. Clinsytes provides comprehensive clinical operations support to small and mid-size life science companies, helping them drive excellence in operational performance and achieve critical study and company milestones.

With over 25 years of experience in the healthcare industry, Shari has dedicated her career to improving the lives of patients with diseases through strategic clinical trial development and operational excellence. As an accomplished clinical operations leader, she has successfully driven clinical trial development and operational processes by providing clinical trial operational start-up strategies, vendor CRO selection and management, and clinical trial conduct oversight while building and maintaining client relationships and developing successful teams.

Shari's expertise spans the entire clinical development lifecycle, with particular strength in strategic clinical trial development planning, KOL and thought leader relationship building, competitive environment analysis, and project management oversight. Her comprehensive skill set includes vendor selection for CROs, laboratories, imaging, drug labeling, packaging, and logistics, as well as RFI/RFP preparation, contract negotiation, and strategic alliance oversight.

Throughout her career, Shari has developed deep expertise across multiple therapeutic areas including oncology (solid tumor, hematology, and ATMP), neurology with a focus on neurodegenerative diseases (ALS, Parkinson's, Multiple System Atrophy), infectious diseases, wound and burn care, rare diseases, diagnostics, and regenerative medicine. This broad therapeutic knowledge allows her to provide specialized insights and solutions tailored to the unique challenges of each disease area.

Prior to founding Clinsytes, Shari served as North American Vice President and Managing Director at Stiris Research (2013-2017), where she was instrumental in driving the company's inclusion in Canada's top 500 fastest-growing profitable companies. She successfully grew the internal team from 4 to 30 employees while maintaining a collaborative, performance-based culture and overseeing clinical operations and business development activities.

From 2010 to 2013, Shari held the position of Clinical Development Director at Becton Dickinson, where she executed and exceeded corporate clinical objectives to increase market share across Canada. She successfully implemented global post-marketing clinical trials and developed key opinion leaders and thought leaders to drive product adoption and market growth.

Shari holds a Bachelor of Science in Nursing (BScN) from the University of Western Ontario (Kings Campus/Fanshawe Nursing School) and earned a Master's Program Certificate in International Wound Care from the University of Toronto. She maintains numerous professional certifications including Six Sigma Green Belt, SOCRA, GCP-ICH, and holds memberships in ACRP, BIO, and the Canadian Woman Executive Leader Forum.

Since founding Clinsytes, Shari has provided interim VP of Clinical Operations services to numerous start-up companies across diverse therapeutic areas, conducted GCP quality audits for over 40 organizations, developed and implemented scientific advisory programs, and created SOPs for multiple companies. Her collaborative approach and consultative communication style have enabled her to build strong relationships with clients and establish a positive brand while fostering continuous client engagement.

Shari believes in leveraging collaborative and consultative communication combined with in-person relationship building to establish a strong foundation for successful clinical programs. She is adept at working effectively both as a senior team member and as an individual contributor, always focusing on achieving goals that improve operational efficiencies and outcomes for clinical trial start-up and management processes.

At NexusBio Partners, we specialize in providing expert consulting services for drug development in the biotechnology sector. Our team of experienced professionals offers insights that can help streamline your research processes and enhance your product development timelines. We are committed to guiding you through the complexities of biotech with tailored strategies.