Head of Diagnostic Reference Materials

Head of Diagnostic Reference Materials
£65,915 p.a. + benefits
Contract: Full time/ Permanent
Location: South Mimms, Hertfordshire
Ref: 228501

We are currently looking for a Head of Diagnostic Reference Materials to join our Standards Lifecycle Function within the Scientific Research and Innovation group.

This is a full-time opportunity, on a permanent basis. This role is primarily based at our South Mimms site with occasional remote working a possibility, dependent upon the nature of the role. Not all roles will be suitable for remote working. Please be aware that this role can only be worked in the UK and not overseas.

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research.

The Scientific Research and Innovation Group of the MHRA delivers public health impact, world-leading research innovation, and a unique proposition via an ambitious Science Strategy which balances innovation against sustainability and affordability.

Within Scientific Research and Innovation, the Standards Lifecycle function is a team of approximately 60 staff dedicated to the design, manufacture and delivery of an Internationally impactful portfolio of reference materials spanning vaccines, therapeutics and diagnostics, all with a focus on improving medicines and patient safety through facilitating accurate and repeatable measurement. We maintain a portfolio of over 1300 reference materials with global distribution. A subset of these, the diagnostic reference material portfolio, particularly supports the harmonisation and independent quality control of diagnostic assays that contribute to accurate timely diagnosis and subsequent treatment.

The successful candidate will lead a team responsible for the scientific, strategic and management oversight of all aspects of the diagnostic reference material portfolio of serological and molecular reagents (currently ca. 150 products) including compliance to National and International governance and regulatory requirements. Our current capabilities are most extensive in infectious disease diagnostics both in technical expertise and breadth of products. You will use your extensive knowledge of the needs of diagnostics laboratories to balance maintaining this strength against ensuring new and developing areas of patient diagnostic needs are supported (eg. Cancer diagnostics, advanced therapies).

Key responsibilities:
• Ensure dynamic management of all products through the lifecycle including timely replacement of existing materials, the development of novel materials in conjunction with the R&D group and providing operational key metrics as required by Head of Standards Lifecycle.
• Maintain your in-depth knowledge of the clinical diagnostic sector including relevant regulatory needs to ensure that the Diagnostic portfolio remains impactful and sustainable.
• Engage with stakeholders across a range of sectors (industry, clinical, regulatory) to identify opportunities to support external reference material programs to promote financial sustainability.
• Manage the Diagnostics Team in the Standards Lifecycle Function of SRI and be accountable for the scientific activities they undertake as well as HR, Finance and Governance aspects pertaining to their work.

Who are we looking for?
The successful candidate will have extensive experience in the field of clinical diagnostics and / or reference materials design and production particularly in emerging fields of diagnostics supporting advanced therapies / cancer. You will have specialist knowledge of and practical experience in a broad range of diagnostic laboratory techniques, including understanding the impact of new technologies on reference material design. You will have significant experience collaborating or communicating across different organisations, government departments, bodies, or external partners.

The successful candidate will have a PhD (or equivalent experience) in a relevant scientific discipline with advanced understanding of the principles of biological standardisation diagnostic reference materials development and end user use. You will have proven record and experience in managing and leading teams including management of managers. Confidently lead a team and effectively manage team dynamics to drive forward a shared goal taking into consideration everyone’s individual needs and creating a genuine team spirit.

Closing date: 12 August 2022.

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