Recruitment Data Policies Associate Director, Clinical Trial Devices

UCB • Atlanta, GA

14h • Hybrid

About The Position

The Associate Director, Clinical Trial Devices (Device Single Point of Contact, DSPOC) provides end-to-end leadership, coordination, and oversight of device-related activities across the clinical lifecycle of assigned candidates and assets in clinical drug development. Device types include 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 device subject-matter experts, backbone functions, and external partners to ensure clear ownership, alignment, and traceability of device-related activities and decisions. The role is based in Raleigh, North Carolina, or Atlanta, Georgia, with a hybrid schedule requiring 40% onsite.

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 (MDs), software as a medical device (SaMD), in vitro diagnostics (IVDs), digital health technologies (DHTs), and ancillary devices used in clinical trials.

Nice To Haves

• Master's degree or advanced professional or doctoral degree, such as PhD, MD, or PharmD.
• Track record of leading complex, cross-functional programs and demonstrating leadership, strategic thinking, and innovation, with 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, and 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) end-to-end device process at the candidate/asset and study levels, including planning, execution, coordination, and oversight.
• Define and drive device strategy by anticipating needs, enabling proactive risk-based decisions, and integrating devices 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 device-related activities, decisions, and deliverables concerning off-the-shelf devices planned for UCB candidate and asset clinical development.
• 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.
• Perform risk categorization and identify, assess, and escalate device-related risks.
• 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 stakeholders are engaged at the appropriate time and aligned across programs.

Benefits

• A caring, supportive, and inclusive culture where employees are respected and have equal opportunities.
• Opportunities to grow and the freedom to shape a career path.

What This Job Offers

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