Associate Director EU CTR Strategy & Operations Excellence Lead

Job Scope: What is this jobs focus

The Associate Director EU CTR Strategy & Operations Excellence supports the Head of EU CTR in providing leadership and strategic oversight for the implementation optimization and continuous improvement of all EU Clinical Trials Regulation (EU CTR) processes within the organization. This role ensures consistent process execution compliance and operational excellence across CTIS (Clinical Trials Information System) submissions and lifecycle management activities. Acting as the process owner and operations excellence lead the role focuses on developing and maintaining frameworks training programs and controls that enable a harmonized and compliant EU CTR fit for purpose operating model across all member states.

Key Responsibilities:

Strategic Process Governance and Oversight

• Support the Head of EU CTR in defining and maintaining the EU CTR operating model including standard procedures RACI frameworks and control mechanisms.
• Lead the establishment of oversight routines KPIs and performance dashboards to monitor compliance and operational effectiveness.
• Ensure alignment of EU CTR operational processes with corporate regulatory strategies and global process standards.
• Coordinate process control reviews and readiness assessments to drive continuous improvement and ensure adherence to EU CTR requirements.

Operational Process Control

• Maintain end-to-end EU CTR process maps workflows and control points for submissions and trial maintenance activities.
• Monitor process execution through quality reviews deviation tracking and performance metrics to identify risks and improvement areas.
• Support audit readiness and act as a subject matter expert (SME) during inspections internal audits and CAPA development.

Learning and Capability Building

• Develop and oversee EU CTR learning and competency programs for all functions engaged in CTIS operations.
• Define and maintain training curricula and certification frameworks to ensure consistent knowledge and compliance across all EU CTR Part I and Part II teams.
• Partner with Learning & Development and functional leaders to embed EU CTR capability frameworks within corporate learning systems. Change

Leadership and Cross-functional Collaboration

• Drive and support process change management initiatives ensuring successful adoption of new workflows tools and regulatory updates.
• Collaborate with Regulatory Affairs Clinical operations Clinical Development Quality and IT to ensure seamless cross-functional process alignment.
• Act as liaison to external regulatory and industry working groups to maintain awareness of evolving EU CTR and CTIS developments.

Essential Skills and Qualifications Required

• Advanced degree (Pharmacy Life Sciences or related discipline) or equivalent professional experience.
• Minimum 12 years of experience in clinical or regulatory operations within the EU region.
• Extensive experience in learning and capability building process control and change management demonstrated by a strong track record of delivery.
• Proven experience in EU CTR implementation CTIS process design and governance management.
• Strong background in process excellence continuous improvement and training program development.
• Demonstrated leadership and influence in a complex matrix environment.
• Strong knowledge of the EU regulatory landscape clinical trial operations and regulatory submissions.
• Excellent strategic thinking problem-solving and project management skills.
• Superior interpersonal communication and organizational abilities
• Strengthened EU CTR governance and process maturity across functions.
• Reduced submission deviations rework and regulatory RFIs.

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.