Head of Clinical Standards

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. Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. 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, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application. 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 EMEA-Reasonable_Accommodation@ucb.com . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. Requisition ID: 93762  Recruiter: Pierre-Julien Dechassat  Hiring Manager: Alexis Harper  Talent Partner: Bianca Hinshaw Job Level: SM I Please consult HRAnswers for more information on job levels.