Associate Director, Global Clinical Operations - EMEA/LATAM

Associate Director, Global Clinical Operations – EMEA/LATAM

Location: NYC Metro Area or San Francisco Bay Area

Work Arrangement: Hybrid – Minimum 3 Days Onsite

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About the Opportunity

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.

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).

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.

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.

Key Responsibilities

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

Qualifications & Experience

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

Why Consider This Opportunity?

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

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.