Recruitment Data Policies Associate Director, Clinical Trial Devices

UCB • Raleigh, NC

13h • Hybrid

About The Position

The Associate Director, Clinical Trial Devices (Device Single Point of Contact, or DSPOC) leads, coordinates, and oversees device-related activities throughout the clinical lifecycle of assigned candidates and assets in clinical drug development. The role covers in vitro diagnostics (IVDs), investigational medicinal product preparation and administration devices (IMPPADs), digital health technologies (DHTs), and other off-the-shelf medical devices.

As an integral member of clinical teams, the DSPOC connects clinical drug development with device subject-matter experts, backbone functions, and external partners. The role ensures clear ownership, alignment, and traceability of device activities and decisions, and integrates device strategy into clinical development, study design, and study documentation. The position is based in Raleigh, North Carolina, or Atlanta, Georgia, with a hybrid schedule requiring 40% onsite work.

Requirements

• Bachelor’s degree.
• At least 8 years of relevant experience in the biopharmaceutical or life sciences industry or within a CRO, including operational experience in clinical drug development and/or clinical trials.
• Experience interpreting and applying regulatory and clinical frameworks across two or more device modalities, including medical devices, software as a medical device, in vitro diagnostics, digital health technologies, or ancillary devices used in clinical trials.

Nice To Haves

• Master’s degree or advanced professional or doctoral degree, such as a PhD, MD, or PharmD.
• Track record of leading complex, cross-functional programs, with strong leadership, strategic thinking, and innovation, and the ability to influence and align stakeholders in a matrix environment.
• Expertise in GCP standards, including ICH E6 and/or ISO 14155.
• Practical experience with device regulations in one or more geographies, such as EU MDR, EU IVDR, FDA QMSR, 21 CFR Part 812, or FDA DHT guidance.
• Familiarity with state-of-the-art medical device development standards, such as ISO 14971 and IEC 62366-1.

Responsibilities

• Lead the DICE (DevICEs across the clinical lifecycle) process end to end at the candidate/asset and study levels, including planning, execution, coordination, and oversight.
• Define and drive device strategy, anticipating needs early and enabling proactive, risk-based decisions integrated into clinical drug development, study design, and study documentation.
• Support selection of fit-for-purpose devices aligned with study endpoints, target population, 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 activities, decisions, and deliverables related to off-the-shelf devices planned for clinical development of UCB candidates and assets.
• Establish and maintain consistent governance, prioritization, and decision-making across device-related activities.
• Represent device strategy and related risks at technical governance forums, including Technical Review and Candidate/Asset Boards.
• Categorize risks, identify and assess device-related risks, and escalate them as appropriate.
• Lead and coordinate the Device Strategy Community (DSC) and Device Excellence Network (DEN), mobilizing appropriate expertise.
• Connect device subject-matter experts, backbone functions, and external partners, ensuring appropriate stakeholders are engaged and aligned across programs.

Benefits

• Hybrid-first approach to work, with 40% of time spent in the office unless otherwise stated or precluded by the position.
• Caring, supportive, and inclusive culture with equal opportunities.
• Opportunities to grow and shape a career path.

What This Job Offers

• Job Type: Full-time
• Career Level: Director