Senior Device Strategy Lead for Clinical Trials

UCB S.A.; Princes Risborough; Hybrid; GBP 125,000 - 158,000; Full time

Job summary

UCB is seeking an Associate Director, Clinical Trial Devices to lead the DSPOC in the Global Regulatory Device Strategy team. Based in a hybrid setup, you will oversee end-to-end device activities across clinical development, including MDs, SaMD, IVDs, and DHTs.

You will drive device strategy, governance, and risk management, ensuring alignment with study endpoints and endpoints across programs. You will collaborate with device SMEs, backbone functions, and external partners to secure clear

Qualifications

• 8+ years of relevant experience in the biopharmaceutical or life sciences industry or within a CRO.
• Experience interpreting and applying regulatory and clinical frameworks across two or more device modalities.

Responsibilities

• Lead the end-to-end device process across candidate/asset and study levels, ensuring effective planning, execution, and oversight.
• Define and drive the device strategy by anticipating needs early and integrating into study design and documentation.
• Support the selection of fit-for-purpose devices aligned with study endpoints and operational context.
• Lead the creation, approval, and maintenance of the Device Strategy Document (DSD), Device Study File (DSF), and Device Assessment Report Document (DARD).
• Serve as the accountable person for all device-related activities and deliverables for off-the-shelf devices in clinical development.
• Establish governance, prioritization, and decision-making across device-related activities.

Skills

Leadership

Regulatory knowledge

GCP standards

Stakeholder influence

Cross-functional collaboration

Strategic thinking

Education

Bachelor's Degree

Job description

UCB is seeking an Associate Director, Clinical Trial Devices to lead the DSPOC in the Global Regulatory Device Strategy team. Based in a hybrid setup, you will oversee end-to-end device activities across clinical development, including MDs, SaMD, IVDs, and DHTs.

You will drive device strategy, governance, and risk management, ensuring alignment with study endpoints and endpoints across programs. You will collaborate with device SMEs, backbone functions, and external partners to secure clear