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 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.
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Skills Required
- BA/BS degree
- Advanced degree (MS, PharmD, PhD, MBA)
- 12+ years 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
- Deep knowledge of regional regulatory frameworks, ethics review processes, and clinical research environments in Latin America
- Recognized expertise in country feasibility, site selection, startup strategy, and operational delivery
- Professional fluency in English (written and spoken)
- Ability to travel extensively throughout the region
- Proven ability to operate effectively within a matrixed global organization
- Strong strategic thinking, negotiation, relationship management, communication, presentation, and executive stakeholder management skills
What We Do
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate. We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
