|Post title and post number||BPMC Industry Trials Hub Team Lead|
|College/Budget Centre||PHTA Ltd|
|Full time/Part time||Full time|
|Duration of the Post||Open|
|Salary||£45,000 – £65,000|
|Additional information||Bonus scheme + generous holiday allowance|
|Closing Date||Friday 29th October|
|UoB Equivalent Grade||8/9|
The role of the Industry Trials Hub Team Lead is to establish and lead a new programme of clinical trials focussed on industry collaborations and support the infrastructure and governance arrangements to enable delivery of clinical trial datasets compliant with EMA and FDA regulatory standards for licensing submissions.
This new post will lead the Industry Trials Hub (ITH) that will be integral to the Birmingham Precision Medicine Centre (BPMC), a division of PHTA Ltd. The BPMC aims to be a state-of-the-art structure that offers access to the expertise of key opinion leaders on clinical trial design and biological sample investigation, working together in a unique structure that will deliver a flexible and comprehensive service to address industry needs for translational medicine. The ITH Team Lead will work closely with the existing University of Birmingham Cancer Research UK Clinical Trials Unit (CRCTU) and Birmingham Clinical Trials Unit (BCTU) (collectively the Birmingham Centre for Clinical Trials) and act as an interface between these Trials Units and industry partner and vendors.
The ITH Team Lead will assist the Birmingham Centre for Clinical Trials in developing and delivering a new portfolio of industry collaborative trials that are aimed to support commercial outputs, hereafter referred to as ‘fit-for-filing’ trials. The post-holder will be responsible for providing specialist regulatory advice and support for these types of trials, will contribute to the engagement of industry partners, provide an evaluation of the trial management needs and associated costs for fit for filing trials, preparing funding applications to industry, coordinating.
They will be responsible for supporting Birmingham’s clinical trials unit staff and investigators in delivering University-sponsored ‘fit-for-filing’ trials in accordance with the applicable regulations and quality standards. They will be responsible for developing and maintaining standard operating procedures that will enable CTUs to in their delivery of these trials. They will actively contribute to the delivery of the ITH trials including supporting the design, implementation, conduct, analysis, and presentation of fit-for-filing trials to ensure that they are compliant with the regulations and quality standards required for Marketing Authorisations. They will also work closely with the Trials Unit teams to ensure delivery of the ITH trials in an expedited fashion in line with agreed ITH timelines.
The post holder will lead the BPMC’s Industry Trials Hub and will contribute to the wider operation of the Precision Health Technologies Accelerator working closely with Trials Management staff in the Trials Units. They will be based initially within the Institute of Translational Medicine (ITM) before moving into the new PHTA facility on the newly developed Birmingham Health Innovation Campus. The post holder will work closely with the Senior Leadership and Quality Management Teams within the CTUs and University.
The University of Birmingham is leading transformational change in the region’s health and life sciences innovation ecosystem that will deliver significant and long-lasting improvements to the health and wealth, of the region and nationally.
Working through Birmingham Health Partners (BHP), the Midland’s leading academic-NHS partnership, the University is building on BHP’s nationally recognised strengths in healthcare data informatics and systems; genomics medicine and diagnostics; medical technologies evaluation and clinical trials, to establish the Precision Health Technologies Accelerator (PHTA) – the anchor innovation capability on the new Birmingham Health Innovation Campus due to open in 2023.
The PHTA will provide the early incubation, grow-on space and innovation services for businesses working across biopharma (including advanced therapies), diagnostics, digital health and advanced healthcare technologies to accelerate the development and delivery of new precision drugs, diagnostics and healthcare technologies into the clinic. Run and operated by PHTA Ltd, a wholly owned subsidiary company of the University of Birmingham, PHTA will deliver a commercially-focused, innovative end-to-end clinical and academic partnership for the delivery of precision medicine solutions. Ahead of the facility opening, PHTA Ltd will operate from within the Institute of Translational Medicine, building a strong pipeline of commercial projects through one of its two divisions: Birmingham Precision Medicine Centre (BPMC).