"Head of Quality Assurance"

An exciting opportunity to join the Southampton Clinical Trials Unit (SCTU), within the University of Southampton, in a senior leadership role as the Head of Quality Assurance.

SCTU is a leading UK academic CTU located within the state-of-the-art Centre for Cancer Immunology building at Southampton General Hospital.

SCTU is a UKCRC registered CTU and is core-funded by Cancer Research UK (CRUK) together with funding from the National Institute for Health and Care Research (NIHR) via the Biomedical Research Centre (BRC) and Research Support Service (RSS).

SCTU has expertise in the design, conduct and publication of clinical trials and other well-designed studies from first-in-human phase I to practice changing phase III trials to large early diagnosis observational studies with rich translational data. Managing a growing portfolio (75% cancer, 25% non-cancer) that covers the complete spectrum of clinical practice, from primary care through to tertiary referral medicine, including pan-cancer experimental therapeutics, surgery, radiotherapy and early diagnosis. Undertaking multi-centre early and late phase clinical trials, we work nationally and internationally to create the evidence for patient benefit that will directly influence routine clinical practice in the NHS and overseas.

As part of the CRUK and NIHR infrastructure we have close working relationships with our partners, including the Southampton Experimental Cancer Research Centre, NIHR BRC & RSS, University Hospital Southampton, the Centre for Cancer Immunology discovery community and CRUK Centres and Institutes across the UK, with an increasing number of international collaborations.

The Head of QA will have a senior leadership role within SCTU, providing strategic and operational oversight for QA, pharmacovigilance and monitoring. SCTU has an established portfolio to CTIMP, NIMP and device trials in the UK with a developing portfolio of international trials with its first trials open in Australia and existing collaborations with Canada, Ireland and other European countries. SCTU currently have just over 120 plus staff with the expectation of further growth over the next 5 years as research opportunities arise.

This is a rare and exciting opportunity for someone to lead the QA for SCTU in close consultation with the SCTU Director and Associate Directors. The post holder will also work with CRUK Head Office in strategic areas of development alongside sister UK CRUK CTUs and have close liaison with the numerous academic sponsors of SCTU trials.

The appointed person must have proven strategic management and managing change experience, knowledge of clinical trial methodology and regulatory requirements. Having worked within a UKCRC CTU is desirable but not essential.

This position is full time fixed term for 5 years (in the first instance as CTU core funding is on a 5 years basis with a future application for renewal).

The employing organisation is the University of Southampton which offers a competitive salary, pension scheme, generous holiday entitlement and other benefits.

For informal queries please contact Richard Hocking, SCTU Associate Director of Operations, SCTU: r.hocking@soton.ac.uk