Head of Biosafety, Non-clinical and Emerging Technologies

We are currently looking for a Head of Biosafety Non-Clinical & Emerging Technologies to join our Benefit Risk Evaluation I Team within the Safety & Surveillance group.

This is a full-time opportunity on a permanent basis. The role will be based in 10 South Colonnade Canary Wharf London E14 4PU. Please be aware that this role can only be worked in the UK and not overseas.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible hybrid way of working with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role this can flex up to 12 days a month with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly.

Who are we

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 Safety and Surveillance (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agencys data and evidence generating capabilities complementing our signal generating abilities.

Against this background and the drive to improve treatment availability for patients safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying assessing and managing the risks associated with medical products. In every aspect of this work we harness the best science technology information and professional practice to protect patients in new and impactful ways.

Whats the role

We are looking for an ambitious forward-thinking leader to head the Biosafety Non-Clinical & Emerging Technologies team. The role will suit an experienced clinician academic or regulatory specialist with expertise in pre-clinical assessment toxicology genomics or in vitro diagnostics and an interest in protecting patient safety. This role presents a unique opportunity to lead a dynamic cross-disciplinary group focused on the cutting-edge intersection of medicines devices and evolving therapeutic modalities.

The post holder will lead the integration of scientific clinical and technical expertise to deliver high-quality benefit-risk assessments and ensure effective matrix working across the Benefit-Risk Evaluation functions the wider Safety and Surveillance Group and Agency lifecycle group. The role is pivotal in ensuring timely and robust responses to potential safety concerns directly informing evidence-based regulatory decisions that uphold public health and product performance standards.

In this role you will lead critical activities related to:

Key responsibilities:

• Non-clinical toxicology: support for toxicological genotoxicity carcinogenicity and reproductive toxicity assessments in the safety of medicines including in silico modelling to enhance safety evaluations.

• Biological safety and sterilisation and decontamination assessment: underpinning both post-market surveillance and clinical investigations for medical devices.

• Pharmacogenomics for pharmacovigilance: co-ordinate policy on the integration of pharmacogenomics with pharmacovigilance to support personalised medicine ensuring our approach remains at the forefront of healthcare.

• Emerging technologies: lead policy on post-market surveillance and risk assessment of diagnostics as well as emerging and advanced technologies such as nano-enabled medicines and devices ATMPs (Advanced Therapy Medicinal Products) and synthetic biology products.

Who are we looking for

Oursuccessful candidatewill have:

• Experience in pre-clinical assessment toxicology genomics or diagnostics; this is essential.

• Experience of working at a senior level communicating effectively with a range of senior level stakeholders is essential.

• Experience of leading and/or managing diverse multidisciplinary teams and work programmes to deliver results to tight deadlines.

• Expertise in the relevant clinical scientific academic or technical field including evidence of up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports scientific publications or reviews or manuscripts for regulatory submissions is essential.

• Delivering at Pace: Evidence of ability to work in a pressurised target driven environment delivering results on time within a range of deadlines maintaining high standards of quality.

If you would like to find out more about this fantastic opportunity please read our Job Description and Person Specification!

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

Online application form including questions based on theBehaviour Experience and Technical Success Profiles.Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind and our Hiring Managers will not be able to access your CV when reviewing your application.

Presentation to be prepared as part of your interview with further information being supplied when you reach this stage.

Interview which can include questions based on theBehaviour Experience Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications we will hold an initial sift based on the lead criteria of: expertise in the relevant clinical scientific academic or technical field including evidence of up-to-date specialist level of knowledge and evidence of analysis of data and preparation of reports scientific publications or reviews or manuscripts for regulatory submissions is essential.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allowsufficienttime. You can view the competencies for this role in the job description.

Use of AI in Job Applications

Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others or generated by artificial intelligence as your own.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:13 July 2025

Shortlisting date: w/c 14 July 2025

Interview date:04-07 August 2025

Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome.

If you need assistance applying for this role or have any other questionsplease contact

Candidates will be subject to UK immigration requirements as well as Civil Service nationality information on whether you are able to apply is availablehere.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

Certain roles within the MHRA will require post holders to have vaccinations and in some circumstances routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens

• Maintenance roles particularly those required to work in laboratory settings

• Roles that involve visiting other establishments where vaccination is required

• Roles required to travel overseas where specific vaccination may be required.

Applicants who are successful at interview will be as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicants details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes including Tax-Free Childcare. Determine your eligibility here.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact .