Your newpany
Hays have been exclusively retained by an extremely well-funded biotech driving breakthrough innovations in the space of gene therapy.They have developed an innovative new technology that allows them to deliver gene therapies in a novel way to patients with rare diseases and are currently going into their initial clinical trial to validate its use. Alongside this they have multiple other programmes approaching the clinic and several more in development, giving them a very strong pipeline.Thepany prides itself on innovation and collaborative work and has a very experienced senior leadership & technical team coupled with a C-suite with a truly impressive track record.They are looking to add a Director / Senior Director of Process andpliance to help them move thepany’s Clinical Technologies forward and are offering an excellent package plus significant remote working flexibility and the chance to make a real impact.
Your new role
This is a permanent position, working closely with the CEO, VP Biometrics and other senior stakeholders to ensure clinical (and potentially other, earlier discovery) technologies remainpliant with regulatory requirements as well as driving innovation within this space, eg through the adoption of new processes/technologies/software, etc.Thepany is ideally looking for candidates to spend some time in office, but the exact amount is open for discussion dependent on candidate location and other factors.Major responsibilities will include a mix of (but aren’t limited to):
Establish the implementation roadmap for all clinical technologies that enable clinical trial management and data collection mechanisms Develop, manage and implement processes for clinical technology adoption and management, eg software solutions Drive new technology solutions for site visits, clinical monitoring, risk management and provide clinical operations colleagues with innovative ways to make a broader impact on the lives of the patients in our studies Oversee / manage projects to integrate and implement new technologies within clinical data capture or similar Manage the creation of new - and optimisation of existing - quality management processes Liaise with colleagues, eg within IT, Clinical Operations, Biometrics, QA & Regulatory Affairs, to ensure clinical trial activities are properly integrated / aligned to protocols Manage, implement, and develop solutions in site start-up, study recruitment/conduct, and data capture processes across multiple clinical technology programmes Act as a technical expert and leader within the business Drive best practice within the business
What you'll need to succeed
As well as strongmunication skills for dealing with collaborators, stakeholders and vendors/CROs, you should have:A BSc (or equivalent experience) in a discipline such asputer science, biometrics, statistics, IT, or a life sciences discipline such as chemistry, biochemistry or biologyExperience of the clinical drug development environment including experience in clinical software development and application deployment is essential, whether from a QA/CSV standpoint, or the data management/clinical operations sideDeep expertise of regulatory requirements and industry standards relevant to clinical research, ensuringpliance throughout all stages of clinical trials Proven ability to design and/or develop technology solutions deployed in clinical trials – such as CTMS or other relevant technologiesFamiliarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processesWell-versed in the utilisation ofmon tools and technologies within clinical trials, including TMF, CTMS, DCT, and eSource, EDC, etcThe ability to manage multiple concurrent projects and effectively prioritise betweenpeting requirementsExperience of rare disease / small cohort trials would be an advantage, but is not necessary for this role.
What you'll get in return
You'll get the chance to make a significant impact on thepany's clinical development and R&D/discovery projects, taking on project leadership for a number of different aspects, driving the adoption of new protocols and processes to make their operations as innovative and effective as possible whilst maintainingpliance with regulatory standards.Thepany are very flexible on salary bands and package depending on the skills of the personing in and you will be a key member of a highly experienced team, with direct access to the C-suite leadership.
