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(Senior) Director - Clinical Technology Process & Compliance, London
Client:
Location:
London, United Kingdom
Job Category:
Other
-
EU work permit required:
Yes
Job Reference:
27030f52c200
Job Views:
14
Posted:
28.04.2025
Expiry Date:
12.06.2025
Job Description:
Your company
Hays has been exclusively retained by an extremely well-funded biotech company driving breakthrough innovations in gene therapy. They have developed an innovative technology for delivering gene therapies to patients with rare diseases and are entering their initial clinical trial to validate its use. They have multiple programs approaching the clinic and in development, with a strong pipeline. The company values innovation and collaboration, supported by experienced leadership and a talented technical team. They are seeking a Director / Senior Director of Process and Compliance to advance their Clinical Technologies, offering an excellent package, remote working flexibility, and the opportunity to make a significant impact.
Your new role
This permanent position involves working closely with the CEO, VP Biometrics, and other senior stakeholders to ensure clinical (and potentially early discovery) technologies comply with regulatory standards and to foster innovation through new processes, technologies, and software. The company prefers some in-office presence, but flexibility is available depending on the candidate's location and circumstances. Key responsibilities include:
1. Establish the implementation roadmap for clinical technologies supporting trial management and data collection
2. Develop and manage processes for clinical technology adoption and management
3. Drive new technology solutions for site visits, monitoring, risk management, and patient impact
4. Oversee projects to integrate and implement new technologies in clinical data capture
5. Manage creation and optimization of quality management processes
6. Collaborate with IT, Clinical Operations, Biometrics, QA, and Regulatory teams for trial integration
7. Manage solutions in site start-up, recruitment, conduct, and data processes
8. Act as a technical expert and leader
9. Promote best practices within the organization
What you'll need to succeed
Candidates should have strong communication skills and possess:
* A BSc or equivalent in computer science, biometrics, statistics, IT, or a life sciences discipline
* Experience in clinical software development and deployment, including QA/CSV or data management/operations
* Deep knowledge of regulatory requirements and industry standards for clinical research
* Proven ability to design or develop clinical trial technology solutions
* Familiarity with navigating the clinical trial lifecycle and regulations like 21-CFR Part 11
* Experience with clinical tools such as TMF, CTMS, DCT, eSource, EDC
* Ability to manage multiple projects and prioritize effectively
* Experience with rare disease or small cohort trials is advantageous but not essential
What you'll get in return
You will have the opportunity to significantly impact the company's clinical development and R&D projects, leading various initiatives to adopt new protocols and processes, ensuring compliance and innovation. The company offers flexible salary packages based on experience and a role within a highly skilled team with direct access to executive leadership.
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