Associate Director, Clinical Trial Devices

The Associate Director, Clinical Trial Devices (Device Single Point of Contact, DSPOC) is accountable for end-to-end leadership, coordination, and oversight of all device-related activities across the clinical lifecycle of assigned candidates and assets in clinical drug development. This includes in vitro diagnostics (IVDs), investigational medicinal product preparation and administration devices (IMPPADs), digital health technologies (DHTs), and other off-the-shelf medical devices. Who you’ll work with This role connects clinical drug development with the device landscape. As an integral member of clinical teams, the DSPOC brings together device SMEs, backbone functions, and external partners to ensure clear ownership, alignment, and traceability of device-related activities and decisions. What you’ll do Lead the DICE (DevICEs across the clinical lifecycle) end-to-end device process at the candidate/asset and study levels, ensuring effective planning, execution, coordination, and oversight across all stages. Define and drive the device strategy by anticipating needs early, enabling proactive, risk-based decision-making, and ensuring full integration into clinical drug development, study design, and study documentation. Support the selection of fit-for-purpose devices aligned with study endpoints, target population, and operational context. Lead the creation, approval, and maintenance of key deliverables, including the Device Strategy Document (DSD), Device Study File (DSF), and Device Assessment Report Document (DARD). Serve as the accountable person for all device-related activities, decisions, and deliverables related to off-the-shelf devices planned for use in the clinical development of UCB candidates and assets. Establish and maintain consistent governance, prioritization, and decision-making across all device-related activities. Represent device strategy and device-related risks at technical governance forums, including Technical Review and Candidate/Asset Boards, ensuring informed and aligned decision-making. Perform risk categorization and identify, assess, and escalate device-related risks. Lead and coordinate the Device Strategy Community (DSC) and Device Excellence Network (DEN), ensuring appropriate expertise is mobilized. As an integral member of the clinical team, connect device SMEs, backbone functions, and external partners, ensuring the right stakeholders are engaged at the right time and aligned across programs. Interested? For this role we’re looking for the following education, experience and skills Required: Bachelors Degree 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, but not limited to, medical devices (MDs), software as a medical device (SaMD), in vitro diagnostics (IVDs), digital health technologies (DHTs), and ancillary devices used in clinical trials. Preferred: Master’s degree or advanced professional or doctoral degree, such as PhD, MD, or PharmD Proven track record of leading complex, cross-functional programs and demonstrating strong leadership, strategic thinking, and innovation, with the ability to influence and align stakeholders in a matrix environment. Demonstrated expertise in GCP standards, including ICH E6 and/or ISO 14155. Practical experience with device regulations across one or more geographies (e.g., EU MDR, EU IVDR, FDA QMSR, 21 CFR Part 812, and FDA DHT guidance). Familiar with state-of-the-art standards for medical device development, such as ISO 14971 and IEC 62366-1. This positions reasonably anticipated base salary range is $148,000-$195,000. The actual salary offered will take into account related knowledge, skills, experience and location among other factors and may fall outside the expected range. Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!