Associate Director, Clinical Trial Devices

UCB Inc.; Raleigh (NC); Hybride; USD 148 000 - 195 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement (40% onsite)

Résumé du poste

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).

Responsabilités

• 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.

Connaissances

Regulatory frameworks

Cross-functional leadership

Clinical drug development

Device strategy coordination

Formation

Master's degree

Doctoral degree (PhD/MD/PharmD)

Description du poste

Associate Director, Clinical Trial Devices

We are looking for an Associate Director, Clinical Trial Devices to join us in our Global Regulatory Device Strategy team, based in our office in either Raleigh, NC or Atlanta, GA (hybrid, 40% onsite)

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 elevate 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:

• 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!

About us

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?

At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

At UCB, we've embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless explicitly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.