Associate Director: Device Strategy for Clinical Trials

UCB; Anderlecht; Hybrid; EUR 140,000 - 200,000; Full time

Job summary

UCB in Brussels is seeking an Associate Director, Clinical Trial Devices (DSPOC) to lead device-related activities across the clinical lifecycle for candidates and assets in clinical drug development, including IVDs, IMPPADs, and DHTs.

You will coordinate device strategy, governance, and risk management, define deliverables like the Device Strategy Document (DSD), Device Study File (DSF), and Device Assessment Report (DARD), and partner with device SMEs and external partners to ensure alignment

Qualifications

• 8+ years of relevant experience in biopharmaceuticals or life sciences industry or CRO.
• Experience interpreting regulatory and clinical frameworks across device modalities (MDs, SaMD, IVDs, DHTs).
• GCP/ICH/EU ISO standards familiarity and device regulations across geographies.

Responsibilities

• Lead end-to-end device process across the clinical lifecycle at candidate/asset and study levels.
• Define and drive device strategy and integration into clinical development and study design.
• Oversee creation and maintenance of key deliverables: Device Strategy Document, Device Study File, Device Assessment Report.

Skills

Regulatory understanding

Leadership

Cross-functional collaboration

Clinical trial execution

Education

Master's degree or higher

Job description

UCB in Brussels is seeking an Associate Director, Clinical Trial Devices (DSPOC) to lead device-related activities across the clinical lifecycle for candidates and assets in clinical drug development, including IVDs, IMPPADs, and DHTs.

You will coordinate device strategy, governance, and risk management, define deliverables like the Device Strategy Document (DSD), Device Study File (DSF), and Device Assessment Report (DARD), and partner with device SMEs and external partners to ensure alignment