Associate Director, Global Clinical Operations - EMEA/LATAM

Job Description

Associate Director, Global Clinical Operations – EMEA/LATAM

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Location: NYC Metro Area or San Francisco Bay Area

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Work Arrangement: Hybrid – Minimum 3 Days Onsite

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About the Opportunity

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We are partnering with an innovative, growing biopharmaceutical organization seeking an experienced Associate Director, Global Clinical Operations to support the execution and expansion of its international clinical development programs.

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This opportunity is ideally suited to an experienced clinical operations leader with a strong background managing global, multicenter clinical trials and overseeing regional activities across Europe, the Middle East, Africa (EMEA), and Latin America (LATAM).

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The successful candidate will take ownership of regional study execution, working closely with cross-functional stakeholders and external partners to ensure clinical programs are delivered efficiently, compliantly, and in alignment with organizational objectives.

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This is an exciting opportunity to join a growing clinical development function, contribute to operational strategy, and play a meaningful role in advancing innovative therapies through clinical development.

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Key Responsibilities

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• Provide operational leadership and oversight for clinical trial activities across EMEA and LATAM, ensuring successful delivery against established timelines, budgets, and quality standards.
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• Oversee regional execution of global, multicenter clinical studies, ensuring alignment with study protocols, regulatory requirements, and broader clinical development objectives.
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• Partner with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Operations, Finance, and external service providers.
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• Manage relationships with third-party vendors and clinical research partners, monitoring performance, deliverables, and contractual obligations.
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• Support regional study planning, including country-level feasibility, resource allocation, operational timelines, and milestone tracking.
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• Oversee clinical trial budgets, forecasting, resource planning, and performance metrics to support effective decision-making.
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• Ensure clinical activities comply with ICH-GCP, applicable regional regulations, and established quality standards.
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• Identify operational risks, implement mitigation strategies, and proactively resolve challenges impacting study delivery.
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• Provide strategic and operational guidance to clinical study teams, supporting consistent execution across multiple countries and regions.
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• Oversee clinical documentation and trial management activities, ensuring accurate records, inspection readiness, and compliance with internal procedures.
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• Coordinate regional clinical supply requirements and support logistics associated with international study execution.
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• Communicate study progress, operational risks, and recommendations to senior leadership and key stakeholders.
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• Support the development, mentoring, and potential expansion of regional clinical operations teams.
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• Contribute to continuous improvement initiatives aimed at strengthening clinical trial execution and operational efficiency.
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Qualifications & Experience

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• Bachelor's degree with 10+ years of relevant experience, or postgraduate degree with 8+ years of experience in clinical operations, clinical trial management, or a related discipline.
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• Extensive experience managing global, multicenter clinical trials, ideally across Phase I–IV development programs.
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• Demonstrated experience overseeing clinical trial operations across EMEA and/or LATAM, with strong knowledge of regional regulatory requirements and country-specific operational considerations.
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• Background in oncology clinical development strongly preferred; experience in neuroscience or other complex therapeutic areas is advantageous.
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• Strong working knowledge of ICH-GCP, international clinical research regulations, and clinical trial quality standards.
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• Proven experience managing external vendors, CRO relationships, clinical study budgets, and operational timelines.
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• Demonstrated ability to lead cross-functional teams and influence stakeholders across multiple geographies.
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• Experience with regional resource planning, financial oversight, operational performance metrics, and risk management.
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• Previous people management, mentoring, or team-building experience is highly desirable.
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• Strong organizational, communication, and problem-solving skills, with the ability to manage competing priorities in a dynamic environment.
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• Fluency in English required; additional European or Latin American language capabilities are advantageous.
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• Comfortable operating independently while collaborating with senior clinical development leadership.
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Why Consider This Opportunity?

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This is an opportunity to join a growing biotechnology organization where you can make a meaningful contribution to international clinical development programs.

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The position offers significant regional responsibility, exposure to global clinical strategy, and the opportunity to help shape and strengthen clinical operations as the organization continues to expand.