Associate Director, Clinical Trial Devices

UCB•Raleigh, NC

1d•$148,000 - $195,000•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 modalities include in vitro diagnostics (IVDs), investigational medicinal product preparation and administration devices (IMPPADs), digital health technologies (DHTs), and other off-the-shelf medical devices. The role connects clinical drug development with the device landscape and serves as an integral member of clinical teams. It brings together device subject-matter experts, backbone functions, and external partners to establish clear ownership, alignment, and traceability of device-related activities and decisions. The position 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 a 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, supporting 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 populations, 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 concerning off-the-shelf devices planned for use in clinical development of UCB candidates and assets.
Establish and maintain consistent governance, prioritization, and decision-making for device-related activities.
Represent device strategy and device-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 the right stakeholders are engaged at the right time and aligned across programs.