Device Strategy Lead - Clinical Trials & DSPOC

UCB; Atlanta (GA); Hybrid; USD 148,000 - 195,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

UCB is seeking an Associate Director, Clinical Trial Devices to lead end‑to‑end device activities across the clinical lifecycle for a portfolio of candidates and assets. The role sits in Global Regulatory Device Strategy with hybrid work in Raleigh or Atlanta and 40% onsite.

You will drive device strategy, coordinate DSPOC activities, and ensure risk‑based decisions are integrated into study design and documentation. Strong regulatory experience across multiple device modalities is required.

Qualifications

• Bachelor’s degree required in a relevant field.
• 8+ years of relevant experience in biopharmaceutical, life sciences, CRO or clinical development.
• Experience interpreting/regulatory frameworks across two+ device modalities (MDs, SaMD, IVDs, DHTs).

Responsibilities

• Lead end‑to‑end device process across candidate/asset and study levels.
• Define and drive device strategy with risk‑based decisions and integration into study design.
• Select fit‑for‑purpose devices aligned with endpoints and operational context.
• Create, approve, and maintain key deliverables (DSD, DSF, DARD).
• Act as accountable person for device activities and deliverables.
• Establish governance and decision‑making across device activities.
• Represent device strategy at governance forums and escalate risks.
• Coordinate Device Strategy Community (DSC) and Device Excellence Network (DEN).
• Engage device SMEs and external partners across programs.

Education

Bachelor's Degree

Master’s degree

Job description

UCB is seeking an Associate Director, Clinical Trial Devices to lead end‑to‑end device activities across the clinical lifecycle for a portfolio of candidates and assets. The role sits in Global Regulatory Device Strategy with hybrid work in Raleigh or Atlanta and 40% onsite.

You will drive device strategy, coordinate DSPOC activities, and ensure risk‑based decisions are integrated into study design and documentation. Strong regulatory experience across multiple device modalities is required.