<div class="content-intro"><p>Spyre Therapeutics is a clinical-stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, IL-23, and IL-17A/F as well as rational combination programs.</p></div><p><strong>Role Summary:</strong></p> <p>The Executive Director, Clinical Operations, will provide strategic leadership and hands-on oversight of global clinical trials, ensuring trials are delivered within agreed timelines and budgets and meet quality standards and applicable regulatory requirements.</p> <p>This individual will translate clinical development objectives into operational plans and lead trial execution from start-up through close-out. Responsibilities include trial planning, enrollment, site engagement, CRO and vendor oversight, budget management, risk mitigation, and operational readiness for key trial milestones.</p> <p>The Executive Director will partner closely with Clinical Development and other functions, serve as a key point of contact for CROs and clinical investigators, and develop and mentor Clinical Operations personnel. Success requires sound judgment, accountability, and the ability to balance strategic leadership with hands-on execution in a growing biotechnology company.</p> <p><strong>Key Responsibilities:</strong></p> <ul> <li>Lead the development and execution of clinical operational strategies and study plans aligned with clinical development priorities and corporate objectives. Oversee global clinical trial activities from feasibility and start-up through enrollment, trial conduct, database lock, and closeout.</li> <li>Establish and manage trial timelines, budgets, resource plans, and performance metrics; identify risks early, establish mitigation plans, and drive timely resolution of issues.</li> <li>Partner with Clinical Development and cross-functional colleagues to assess protocol feasibility and contribute operational input to protocols, informed consent forms, study plans, and other trial-related documents.</li> <li>Implementation and management of the clinical operational plans and programs in order to meet corporate goals and objectives.</li> <li>Lead CRO and vendor selection, contracting, governance, and performance oversight, ensuring clear responsibilities, effective communication, and accountability for deliverables.</li> <li>Oversee country and site feasibility, site selection, activation, monitoring, and closeout activities. </li> <li>Build effective relationships with clinical investigators and site teams to support trial execution, participant recruitment and retention, and timely issue resolution.</li> <li>Develop and oversee enrollment strategies along with Medical Affairs, monitor recruitment performance, and implement actions to address enrollment challenges.</li> <li>Partner with Data Management, Biometrics, Clinical Development, and other functions to support data quality, timely query resolution, database lock, and clinical trial reporting.</li> <li>Develop and manage study budgets, oversee contract and budget negotiations, and monitor forecasts, invoices, and payments in partnership with Finance and Legal.</li> <li>Partner with Quality to maintain inspection readiness, support audits and regulatory inspections, and ensure timely resolution of findings and implementation of corrective actions.</li> <li>Develop and maintain Clinical Operations SOPs, processes, and tools; provide training and drive improvements that support quality and efficient execution.</li> <li>Provide clear, actionable updates to senior leadership and Development Teams on study progress, budget performance, risks, and decisions requiring escalation.</li> <li>Lead, mentor, and develop Clinical Operations personnel, establishing clear expectations and fostering collaboration, ownership, and high-quality execution.</li> <li>Maintain current knowledge of relevant therapeutic areas, clinical trial practices, and applicable regulatory requirements.</li> <li>Regularly make presentations to senior staff members and participate in relevant Development Team meetings.</li> <li>Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials.</li> <li>Attend scientific and external training meetings as needed.</li> <li>Other clinical operations activities as required.</li> </ul> <p><strong>Ideal Candidate:</strong></p> <ul> <li>Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred. A minimum of 10 years of global clinical research experience within the pharmaceutical or biotechnology industry.</li> <li>Late-stage dermatology clinical trial experience is strongly preferred.</li> <li>Demonstrated success overseeing clinical trial planning, start-up, enrollment, monitoring, data cleaning, database lock, closeout, and clinical trial reporting.</li> <li>Experience leading CROs and other clinical service providers, including vendor selection, contract negotiation, governance, and performance management.</li> <li>Strong financial and operational management skills, including study budgeting, forecasting, resource planning, and risk management.</li> <li>Thorough understanding of Good Clinical Practice and applicable local and global clin