Director, EU CTR Head & Country and Site Operations

About this role

The Director, EU CTR Head & Country and Site Operations Is a focused leadership role that combines regulatory compliance with operational excellence to ensure the successful delivery of clinical trials across the EU region. This role is responsible for maintaining compliance with the EU Clinical Trial Regulation (CTR) part II, managing the Clinical Trials Information System (CTIS), and providing operational leadership, particularly in Germany, Switzerland, Poland, and with the resources of Functional Service Providers in the assigned EU region.

The position integrates local insights into global plans, ensuring timely and accurate regulatory submissions in the EU and driving the delivery of clinical trials with a focus on operational excellence. Additionally, this position or their direct reports may act as the primary liaison with EU regulatory authorities, industry organizations, and patient advocacy groups, while fostering partnerships to advance clinical trials.

In addition to the EU-CTR responsibility, this position oversees a team of Country and Site Operations, comprising Country Clinical Sciences Leads (CCSLs), Clinical Research Monitors (CRAs), which might include both Full-Time Employees (FTEs) and Functional Service Providers (FSPs) in the assigned countries. This position works with the team to optimize trial delivery and operational performance while ensuring compliance with Good Clinical Practice (GCP), ICH guidelines, and local

regulatory requirements.

At the country/cluster level, the role emphasizes collaboration with affiliates to engage Key Medical Experts (KMEs) and external stakeholders, ensuring alignment and operational execution of Biogen's clinical trials. This individual represents Biogen at in-country scientific, regulatory, and patient organization meetings while providing global teams with detailed local intelligence.

• Regulatory Compliance and CTIS Management : Lead and oversee compliance with the EU Clinical Trial Regulation (CTR), managing all submissions and updates through CTIS. Serve as a key liaison with EU regulatory authorities, track evolving regulatory requirements, and ensure audit readiness across all related activities.
• Country Operations Leadership : Provide strategic operational insights into local regulatory landscapes, site selection, and trial execution across assigned countries. Support high-quality trial delivery by managing country-specific risks and collaborating with affiliate teams and leadership to align local needs with global clinical development goals and regional initiatives.
• Stakeholder Engagement and Representation : Represent Biogen in local industry, scientific, and patient forums to build strong partnerships and enhance the company's presence across the EU. Collaborate with affiliates to engage KMEs and external stakeholders, promoting a unified "One Biogen" approach. Serve as a subject matter expert by sharing local regulatory and operational knowledge to support global planning and strategic decision-making.
• Leadership and People Development : Manage and mentor regulatory and clinical teams, ensuring they are well-equipped to meet EU CTR requirements and deliver operational excellence. Provide ongoing training and support, foster a culture of collaboration and accountability, and drive continuous improvement of internal processes related to CTIS submissions and regulatory compliance.Manage and mentor regulatory and clinical teams, ensuring they are well-equipped to meet EU CTR requirements and deliver operational excellence. Provide ongoing training and support, foster a culture of collaboration and accountability, and drive continuous improvement of internal processes related to CTIS submissions and regulatory compliance.
• Regulatory and Operational Intelligence : Continuously monitor regulatory and trial environment changes across assigned countries, delivering actionable insights to internal teams. Identify local challenges and opportunities to inform global strategies and enhance trial execution, while collaborating closely with the Clinical Trials Acceleration Unit and Global Regulatory Affairs.

• University degree required; an advanced or graduate degree is preferred.
• Minimum of 12 years of experience in clinical development, with exposure to multiple clinical operations functions.
• Proven experience in field-based, site-facing clinical operations roles.
• Demonstrated success in delivering clinical trials via an outsourcing model.
• R&D project leadership experience is a plus but not mandatory.
• Ability to collaborate effectively across multiple functions and global teams.
• Experienced people manager with a strong track record of team development and leadership.
• Deep understanding of GCP, clinical trial regulations, and relevant regulatory guidance within the assigned region.
• Strong interpersonal skills with the ability to communicate effectively across all levels of senior management.
• Comfortable navigating complex regulatory environments and driving operational excellence.