Associate Director, Clinical Trial Devices Strategy

UCB Inc.; Raleigh (NC); Hybrid; USD 148,000 - 195,000; Full time

Benefits offered by this job

Hybrid work arrangement (40% onsite)

Job summary

UCB is seeking an Associate Director, Clinical Trial Devices to join the Global Regulatory Device Strategy team, based in Raleigh, NC or Atlanta, GA (hybrid, 40% onsite). The role leads end-to-end device activities across the clinical lifecycle, including IVDs, IMPPADs, DHTs, and off-the-shelf devices used in clinical development.

You will define device strategy, govern device-related deliverables, and coordinate cross-functional teams to ensure alignment with GCP and ISO standards across

Qualifications

• 8+ years of biopharmaceutical/CRO experience with clinical development.
• Experience interpreting regulatory frameworks across device modalities (MDs, SaMD, IVDs, DHTs).

Responsibilities

• Lead end-to-end device process across candidate/asset studies.
• Define device strategy and integrate into clinical development and study documentation.
• Support device selection aligned with endpoints and operations.
• Create and maintain Device Strategy Document, Device Study File, and Device Assessment Report.
• Coordinate governance and decision-making across device activities.
• Represent device strategy in technical governance forums and boards.
• Identify and elevate device-related risks and lead DSC/DEN initiatives.
• Engage device SMEs and partners to align stakeholders across programs.

Skills

Regulatory frameworks

Cross-functional leadership

Clinical drug development

Device strategy coordination

Education

Master's degree

Doctoral degree (PhD/MD/PharmD)

Job description

UCB is seeking an Associate Director, Clinical Trial Devices to join the Global Regulatory Device Strategy team, based in Raleigh, NC or Atlanta, GA (hybrid, 40% onsite). The role leads end-to-end device activities across the clinical lifecycle, including IVDs, IMPPADs, DHTs, and off-the-shelf devices used in clinical development.

You will define device strategy, govern device-related deliverables, and coordinate cross-functional teams to ensure alignment with GCP and ISO standards across