Director, Clinical Operations Latin America

**About Summit:** Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: **Non-small Cell Lung Cancer (NSCLC)** - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. **Colorectal Cancer (CRC)** - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. *Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.* DIRECTOR, CLINICAL OPERATIONS Overview of Role: The Director, Regional Clinical Operations, Latin America provides strategic leadership, operational expertise, and regional influence to enable the successful execution of Summit Phase I–III oncology clinical trials across the region. The role is part of the Global Clinical Operations (GCO) organization and reports directly to the Senior Director, Clinical Operations Europe. This position serves as the senior clinical operations leader for the region and is accountable for driving country-startup strategy, site activation excellence, stakeholder engagement, and operational delivery across all countries within the region. The Director will leverage extensive regional expertise, established relationships with oncology investigators, sites, institutions, regulatory authorities, ethics committees, and healthcare stakeholders to accelerate trial approvals and study execution. The scope of this role includes all countries within Latin America region and may expand to neighbouring countries based on business needs and portfolio requirements. Role and Responsibilities: Regional Leadership & Strategy · Lead and drive operational excellence for clinical trial execution across Latin America. · Accountable for regional performance against study startup, enrolment, quality, timeline, and budget commitments. · Act as the primary regional escalation point for operational challenges impacting study delivery. · Develop regional operational strategies that maximize speed, quality, patient access, and investigator engagement. · Provide strategic recommendations regarding country selection, site placement, and regional investment decisions. External Stakeholder Engagement · Establish and maintain senior-level relationships with regulatory agencies, ethics committees, health authorities, hospital leadership, research networks, cancer centers, and professional organizations throughout the region. · Influence key external stakeholders involved in clinical trial a…