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Head of Clinical Standards

UCB -
Anderlecht

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Make your mark for patients

Head of Clinical Standards

You will be working in a team that is shaping the future of modern, digital, data‑driven research and development. We are looking for a Head of Clinical Standards who is strategic, collaborative, and forward‑thinking to join us in our Research and Development team, based in our UCB office in Brussels, Belgium.

About the role

You will lead the global strategy, governance, and evolution of clinical standards across the full clinical development life cycle. Your work will ensure that clinical standards are consistent, high‑quality, and aligned with global regulatory expectations. You will drive digital‑first design, enable advanced analytics, and ensure that data generated across studies is reliable, reusable, and ready for regulatory submission. You will act as the organization’s central voice on clinical standards, bridging science, operations, data, technology, and regulation to enable efficient execution, regulatory confidence, and innovation across the portfolio.

Who you’ll work with

You will be working with a broad network of experts across clinical science, clinical operations, data management, biometrics, regulatory affairs, safety, quality, and digital teams. You will chair the enterprise clinical standards network and collaborate closely with functional leaders to ensure consistent adoption and implementation of standards. You will also represent the organization externally, engaging with industry groups and regulatory bodies to stay aligned with evolving expectations and best practices.

What you’ll do

Lead the global strategy for clinical standards, ensuring alignment with regulatory expectations and research and development objectives.
Define, maintain, and evolve clinical standards, templates, terminology, and metadata to ensure consistency, traceability, and interoperability : CDISC standards (SDTM, ADaM, CDASH, Define.xml) and other Open-Source Standards
Drive digital‑first implementation of standards to enable automation, analytics, and modern research and development capabilities.
Establish and oversee global governance, including decision rights, change control, deviation management, and quality‑by‑design principles.
Partner across functions to ensure standards are embedded into systems, processes, vendor ecosystems, and study execution.
Lead enterprise change management, capability building, and external engagement to strengthen standards maturity and adoption.

Interested? For this role we’re looking for the following education, experience and skills

Advanced degrees such as a master’s degree, medical degree, or public health qualification are valued.
10–15+ years of experience in clinical development, clinical data, biometrics, or regulatory environments, with proven global leadership.
Deep expertise in clinical standards and regulatory expectations, with experience leading enterprise governance models.
Strong ability to bridge science, operations, data, technology, and regulation in complex, global environments.
Demonstrated experience applying quality‑by‑design principles and contributing to digital or data transformation initiatives.
Excellent stakeholder influence, strategic thinking, and execution skills in matrixed organizations.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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affairs environment vacatures in brussels, bru

Head of Clinical Standards

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