Director, Clinical Operations Latin America

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 approvals and activation to support efficient regulatory and operational pathways.

· Represent the company at regional scientific meetings, investigator meetings, industry organizations, and external stakeholder forums.

· Monitor and influence emerging regulatory and clinical research trends that may impact oncology development programs within the region.

· Serve as a trusted partner to investigators and institutions to strengthen the company's sponsor reputation and long-term strategic presence.

Investigator & Site Network Leadership

· Maintain a comprehensive and current understanding of leading oncology institutions and investigators across all countries within Latin America.

· Utilize an extensive network of investigator and site relationships to strengthen feasibility assessments and support rapid study startup.

· Partner with global study teams to identify high-performing sites capable of delivering complex oncology protocols.

· Drive initiatives that improve site experience, site retention, and long-term engagement.

Feasibility & Start-up

· Lead regional feasibility strategy and provide expert country-level operational intelligence.

· Ensure robust assessment of regulatory pathways, site capabilities, patient populations, and competitive trial landscapes.

· Influence country startup strategies to optimize timelines and regulatory approval success rates.

· Identify regional barriers to activation and implement proactive mitigation strategies.

· Ensure timely incorporation of regional insights into global study plans.

Operational Oversight

· Maintain oversight of regional study performance and proactively identify risks to timelines, enrolment, quality, or budget.

· Partner with Global Study Teams to develop and implement mitigation plans for regional operational challenges.

· Ensure regional activities are conducted in compliance with GCP, local regulations, company policies, and applicable health authority requirements.

· Support inspection readiness activities and provide regional expertise during audits and inspections.

Experience, Education and Specialized Knowledge and Skills:

· BA/BS required; advanced degree (MS, PharmD, PhD, MBA) preferred.

· 12+ years of pharmaceutical, biotechnology, CRO, or clinical research experience, including 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.