Director, Clinical Operations Middle East

About Summit Therapeutics Inc.

Summit Therapeutics Inc. is a pioneering biopharmaceutical oncology company dedicated to transforming patient outcomes by enhancing quality of life, extending survival potential, and addressing critical unmet medical needs. Our mission is driven by a team of exceptional professionals who share a deep commitment to excellence and innovation. At Summit, we uphold core values of integrity, passion for excellence, purposeful urgency, collaboration, and a steadfast dedication to our people. Our employees are the cornerstone of our culture, embodying the spirit of innovation and compassion that propels our journey toward medical breakthroughs.

Summit’s clinical studies in oncology are designed to touch lives and drive meaningful change. The company is currently advancing multiple global Phase 3 clinical trials, including:

• Non-small Cell Lung Cancer (NSCLC):
  • HARMONi: A Phase 3 study evaluating ivonescimab combined with chemotherapy versus placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have been previously treated with a third-generation EGFR TKI.
  • HARMONi-3: A Phase 3 study evaluating ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
  • HARMONi-7: A Phase 3 study evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
• Colorectal Cancer (CRC):
  • HARMONi-GI3: A Phase 3 study evaluating ivonescimab in combination with chemotherapy compared to bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy currently approved only by China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

Director, Clinical Operations Middle East – Role Overview

The Director, Clinical Operations Middle East, is a pivotal leadership position within Summit’s Global Clinical Operations (GCO) organization. Reporting directly to the Senior Director, Clinical Operations Europe, this role is responsible for providing strategic leadership, operational expertise, and regional influence to ensure the successful execution of Summit’s Phase I–III oncology clinical trials across the Middle East. The Director will serve as the senior clinical operations leader for the region, driving country-startup strategy, site activation excellence, stakeholder engagement, and operational delivery across all countries within the Middle East. This position will leverage deep regional expertise and established relationships with oncology investigators, sites, regulatory authorities, ethics committees, and healthcare stakeholders to accelerate trial approvals and enhance study execution.

The scope of this role encompasses all countries within the Middle East region and may extend to neighboring countries based on evolving business needs and portfolio requirements.

Key Responsibilities

Regional Leadership & Strategy

• Lead and drive operational excellence for clinical trial execution across the Middle East region.
• Ensure accountability for regional performance against study startup, enrollment, quality, timeline, and budget commitments.
• Act as the primary regional escalation point for operational challenges impacting study delivery.
• Develop and implement regional operational strategies that maximize speed, quality, patient access, and investigator engagement.
• Provide strategic recommendations regarding country selection, site placement, and regional investment decisions to optimize clinical trial success.

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 approvals and activations to streamline processes and enhance collaboration.
• Represent Summit at regional conferences, symposia, and industry events to strengthen the company’s presence and reputation in the oncology clinical research landscape.

Operational Execution & Compliance

• Oversee the planning, implementation, and monitoring of clinical trials in accordance with regulatory standards, Good Clinical Practice (GCP), and Summit’s internal policies.
• Collaborate with cross-functional teams, including Clinical Development, Medical Affairs, Regulatory, and Quality Assurance, to ensure seamless trial execution and alignment with global objectives.
• Monitor regional performance metrics and implement corrective actions as needed to maintain high standards of operational efficiency and compliance.

Team Leadership & Development

• Lead, mentor, and develop a high-performing regional clinical operations team to drive excellence in trial execution and stakeholder management.
• Foster a culture of collaboration, innovation, and accountability within the team to achieve regional and organizational goals.