Recruitment Data Policies 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 datadriven research and development. We are looking for a Head of Clinical Standards who is strategic collaborative and forwardthinking 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 highquality and aligned with global regulatory expectations. You will drive digitalfirst design enable advanced analytics and ensure that data generated across studies is reliable reusable and ready for regulatory submission. You will act as the organizations central voice on clinical standards bridging science operations data technology and regulation to enable efficient execution regulatory confidence and innovation across the portfolio.

Who youll 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 youll 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 ) and other Open-Source Standards
Drive digitalfirst 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 qualitybydesign 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 were looking for the following education experience and skills

Advanced degrees such as a masters degree medical degree or public health qualification are valued.
1015 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 qualitybydesign 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 dont just complete tasks we create value. We arent 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 thats 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 weve 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.