At a Glance
- Tasks: Lead device activities in clinical trials, ensuring seamless integration with drug development.
- Company: Join a leading biopharmaceutical company focused on innovative clinical solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with cross-functional teams and global impact.
- Why this job: Shape the future of clinical trials and improve patient outcomes through innovative device strategies.
- Qualifications: Bachelor's degree and 8+ years in clinical development with strong leadership skills.
The predicted salary is between 63000 - 77000 £ per year.
Overview
As Associate Director, Clinical Trial Devices, you will lead end-to-end device activities across the clinical lifecycle for candidates and assets, ensuring seamless integration with clinical drug development.
You’ll convene device SMEs and partners to align decisions, govern device-related work, and drive risk-based, proactive device strategies.
This role sits at the intersection of clinical development and device regulation, shaping how devices support study endpoints and patient outcomes.
You’ll operate in a collaborative, cross-functional environment and influence governance forums to advance programs.
Responsibilities
- Lead the end-to-end DICE device process at candidate/asset and study levels, ensuring planning, execution, and oversight.
- Define and drive device strategy, anticipating needs and enabling proactive, risk-based decision-making within clinical development.
- Support selection of fit-for-purpose devices aligned with study endpoints and operational context.
- Create, approve, and maintain key deliverables: Device Strategy Document (DSD), Device Study File (DSF), and Device Assessment Report Document (DARD).
- Serve as the accountable owner for device-related activities and decisions for off-the-shelf devices in clinical development.
- Establish governance and prioritization across device activities and participate in governance forums (Technical Review, Candidate/Asset Boards).
- Represent device strategy and risks in governance forums to enable informed decisions.
- Lead and coordinate the Device Strategy Community (DSC) and Device Excellence Network (DEN); mobilize device expertise as needed.
- Connect device SMEs, backbone functions, and external partners to ensure timely and aligned stakeholder engagement across programs.
- Key requirements
- Bachelor’s degree
- 8+ years in biopharmaceutical/life sciences industry or CRO with clinical development/clinical trial experience
- Experience interpreting regulatory and clinical frameworks across two or more device modalities (MDs, Sa MD, IVDs, DHTs, ancillary devices)
- Strong leadership and strategic thinking
- Influence and alignment in a matrix environment
- Cross-functional collaboration and communication
- GCP and ICH E6 knowledge
- ISO 14155, ISO 14971, IEC 62366-1 familiarity
- Device regulations across geographies (EU MDR, EU IVDR, FDA QMSR, 21 CFR Part 812, FDA DHT)
Associate Director, Clinical Trial Devices (United Kingdom) in Slough employer: Ucb Group
UCB is an exceptional employer that fosters a collaborative and innovative work culture, where employees are encouraged to push boundaries and create meaningful value for patients. Located in Slough, our hybrid-first approach allows for flexibility while working alongside experienced scientists in a supportive environment that prioritises personal growth and career development. Join us to be part of a team that values inclusivity and empowers you to make your mark in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Clinical Trial Devices (United Kingdom) in Slough
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
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Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Ucb Group!
We think you need these skills to ace Associate Director, Clinical Trial Devices (United Kingdom) in Slough
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Ucb Group that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Ucb Group.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Ucb Group does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Ucb Group
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Ucb Group. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Ucb Group's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Ucb Group. This shows your passion for the industry!