Niki Bellefontaine

I am a scientific and operations leader with +7 years of experience guiding digital transformation, strategic alignment, and scientific and pharmacovigilance operations across specialty pharmaceutical services. As Senior Manager, Scientific Affairs Operations at Bayshore Specialty Rx, I provide strategic oversight of a national portfolio of clinical trial support and real-world evidence programs. My mandate is to ensure alignment between scientific rigor, regulatory compliance, operational scalability, and commercial objectives—translating strategy into sustainable, high-performing execution. I lead complex, regulated portfolios with accountability for budgeting, program governance, and risk management. A core focus of my work is digital enablement, where I help design and implement data-driven operational frameworks that improve visibility, performance measurement, and decision-making. My leadership experience spans: • Scientific affairs program and portfolio strategy • Digital transformation and process modernization, including performance frameworks into scientific operations • Pharmacovigilance and regulatory alignment, including global PV process transitions, SOP/WI architecture, and compliance with ICH-GCP and Health Canada requirements • Stakeholder engagement and people leadership, aligning internal teams, external partners, and sponsors around shared outcomes while building high-performing, accountable teams My background includes leading clinical research programs during periods of accelerated growth and directing pharmacovigilance process transformations for global pharmaceutical partners—work grounded in patient safety, data integrity, and operational excellence. I am drawn to roles where strategy, governance, and innovation intersect, and where scientific operations are positioned as a strategic enabler of organizational growth and patient impact.