Director of LATAM Country and Site Operations

About This Role

The Director, LATAM Country and Site Operations (CSO) provides leadership and operational oversight for Country and Site Operations in Latin America, including Brazil, Argentina, Mexico, Colombia, Chile, and Peru. The position oversees a high-performing regional Country and Site Operations team, comprising Country Clinical Sciences Leads (CCSLs), Clinical Research Monitors (CRAs), and Clinical Monitoring Leads (CMLs), which includes both Full-Time Employees (FTEs) and Functional Service Providers (FSPs). The CSO develops and implements region-specific strategies to optimize trial delivery and operational performance while ensuring compliance with Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.

This role strengthens Biogen's presence in Latin America by building and maintaining relationships with key stakeholders, including clients, investigators, site staff, regulatory bodies, and patient organizations. The Director CSO also acts as a Subject Matter Expert (SME), representing the Country and Site Operations function during the development and execution of global initiatives.

What You'll Do

Operational Leadership

• Provide operational leadership and oversight of Country and Site Operations across the LATAM region.
• Develop and implement specific operational strategies to optimize clinical trial delivery, operational performance, and resource allocation across Brazil, Argentina, Mexico, Colombia, Chile, and Peru.
• Deliver proactive operational intelligence on regional regulatory and clinical trial
• environments to guide country and site selection strategies and enhance trial planning.

• Oversee the planning, execution, and completion of clinical trials in the LATAM region, ensuring adherence to timelines, budgets, and quality standards.
• Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, Standard
• Operating Procedures (SOPs), and local and international regulations governing clinical trial conduct.
• Monitor quality metrics, operational performance, and trial progress, implementing corrective actions when necessary to maintain excellence.

• Lead, mentor, and develop a high-performing regional Country and Site Operations team, including CCSLs, Clinical Project Managers, Clinical Research Associates (CRAs), CRMs, and CMLs (both FTEs and FSPs).
• Assist in recruiting new staff and ensure staff retention and turnover rates remain within expected levels.
• Foster a culture of collaboration, accountability, and professional growth among team members.

• Build and maintain strong relationships with key stakeholders, including clients, investigators, site staff, regulatory bodies, and patient organizations, to strengthen Biogen's presence in Latin America.
• Represent Biogen at local industry, scientific, and patient organization meetings, advocating for the company's clinical programs and fostering external partnerships.
• Facilitate effective engagement with Key Medical Experts (KMEs) in collaboration with affiliate personnel to ensure alignment with clinical and business strategies.

• Act as a Subject Matter Expert (SME), representing Country and Site Operations in the review and execution of global initiatives.
• Provide global teams with detailed regional operational and scientific knowledge from engagements.
• Ensure thoughtful integration of local opportunities and needs into global strategies.

• University degree or equivalent combination of education and experience required; advanced/graduate degree preferred.
• 12+ years' experience in clinical development, experience across multiple clinical operations disciplines including field-based site-facing clinical operations roles, clinical trial delivery via an outsourcing model.
• Deep understanding of the LATAM Clinical Trial environment.
• Ability to collaborate cross functionally.
• Experienced people manager.
• Strong understanding of regulatory environment regarding GCP, clinical trial regulations and regulatory guidances pertinent to clinical trial conduct in assigned region.
• Strong interpersonal and communication skills, including experience working with various levels of senior management.
• Fluent in English.

• R&D project leadership experience preferred.
• Fluency in Spanish.