Recruitment Data Policies Associate Director, Clinical Trial Devices

Make your mark for patients

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)

About the role
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 youll 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 youll 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 were 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:

• Masters 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 $148000-$195000. 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 dont just complete tasks we create value. We arent 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 thats 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 weve 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 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.

Required Experience:

Director