Borealis Biosciences, Inc.

Clinical Operations

• Lead operational planning and execution of Borealis’ clinical development programs from early development through later-stage studies
• Lead end-to-end operational planning and execution of the upcoming Phase 1/2 clinical trial
• Translate clinical development plans and protocols into operational strategies, timelines, budgets, enrollment projections, and risk mitigation plans
• Establish study governance, decision-making processes, and accountability across internal and external study teams
• Deliver studies on time and on budget in accordance with protocols, regulatory requirements, GCP, and Borealis quality standards
• Identify operational risks and lead mitigation and contingency planning
• Partner with Clinical Development, Regulatory, CMC, Data Management, Biostatistics, Translational Medicine, Quality, and other functions
• Own outsourcing strategy and lead CRO identification, competitive selection, RFPs, bid defenses, proposal assessment, contracting, governance, and performance oversight
• Establish and manage CRO and vendor expectations, responsibilities, escalation pathways, KPIs, timelines, quality standards, budgets, and deliverables
• Define vendor strategy for central laboratories, imaging providers, IRT, eCOA, clinical supply/logistics providers, specialty laboratories, and other study service providers
• Develop site identification, feasibility, selection, activation, patient recruitment, and retention strategies
• Monitor enrollment performance and develop mitigation plans
• Build investigator and site relationships and incorporate site needs into study planning and execution
• Design the Clinical Operations organization and develop resourcing strategies
• Recruit, onboard, develop, retain, coach, and mentor Clinical Operations professionals
• Report to the Senior Vice President, Translational Medicine

Head of Clinical Operations – Sr. Director / Executive Director