Job Scope: What is this job’s 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.
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Job Level: Management
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 on to learn more about our DE&I efforts.
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.
