• Serve as a key operational leader, partnering with the COO and executive team to align strategy with execution • Lead company-wide operational planning and ensure alignment with strategic goals • Facilitate forecasts, budget development, resource allocation, vendor payments, and operational performance tracking with Finance • Implement and improve systems, processes, and tools to drive operational scalability and excellence • Implement and maintain the Quality Management System (QMS) and oversee SOP creation, updates, and audit readiness • Ensure compliance across corporate operations, development activities, legal, insurance, and regulatory requirements; foster a culture of compliance • Oversee management of non-owned physical facilities (labs, offices, external manufacturing sites), IT infrastructure, and enterprise software systems • Work closely with the Development team to manage relationships with CROs, CMOs, and preclinical and clinical trial providers • Lead sourcing, procurement, and logistics to support research, development, and external manufacturing operations • Negotiate contracts and ensure cost-effective resource utilization across all operational activities • Manage HCP contracting and compliance processes • Serve as primary point of contact for legal service vendors and coordinate legal operational needs • Identify operational risks, gaps, and bottlenecks, and proactively lead solutions • Manage the Operations team including hiring, performance, coaching, and career development • Drive operational KPIs and reporting, including preparation of materials for executive and board updates • Ensure operational compliance with company policies, regulatory requirements, and best practices