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Summit TherapeuticsPosted 1 month ago

Director, Clinical Operations Latin America

On-siteBrazil, Indiana, United States

Full TimeSenior LevelSmall

Job Summary

Lead regional clinical trial execution across Latin America, driving operational excellence for Phase I–III oncology studies while managing startup strategy, site activation, and enrollment targets. Establish and maintain senior-level relationships with regulatory agencies, ethics committees, and oncology investigators to accelerate approvals and support rapid study delivery. Act as the primary escalation point for regional operational challenges, ensuring compliance with GCP and local regulations while identifying and mitigating risks to timelines and budgets. Partner with global study teams to optimize country selection and site placement, leveraging extensive regional networks to strengthen feasibility assessments and long-term engagement.

Required Qualifications

  • BA/BS
  • 12+ years of pharmaceutical, biotechnology, CRO, or clinical research experience
  • Substantial experience in oncology clinical trials
  • Significant experience leading global clinical trials within Latin America
  • Extensive network of oncology investigators, cancer centers, research institutions, and healthcare stakeholders throughout Latin America
  • Professional experiences working across Latin America
  • Deep knowledge of regional regulatory frameworks, ethics review processes, and clinical research environments
  • Recognized expertise in country feasibility, site selection, startup strategy, and operational delivery
  • Demonstrated ability to influence without authority across complex stakeholder environments
  • Professional fluency in English (written and spoken)
  • Strong strategic thinking, negotiation, and relationship management capabilities
  • Proven ability to operate effectively within a matrixed global organization
  • Excellent communication, presentation, and executive stakeholder management skills
  • Ability to travel extensively throughout the region as business needs require

Desired Qualifications

  • Advanced degree (MS, PharmD, PhD, MBA)

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