Head of Biosafety, Non-Clinical & Emerging Technologies - £76,000 p.a. + benefits (London)

Head of Biosafety, Non-Clinical & Emerging Technologies – £76,000 p.a. + benefits

Join to apply for the Head of Biosafety, Non-Clinical & Emerging Technologies – £76,000 p.a. + benefits role at Medicines and Healthcare products Regulatory Agency

Head of Biosafety, Non-Clinical & Emerging Technologies – £76,000 p.a. + benefits

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Join to apply for the Head of Biosafety, Non-Clinical & Emerging Technologies – £76,000 p.a. + benefits role at Medicines and Healthcare products Regulatory Agency

Job Summary

We are currently looking for a

Canary Wharf, London

Job Summary

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 Agency’s 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. Job Description

What’s 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.

What’s 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.

Person specification 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! Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk Alongside your salary of £76,000, Medicines and Healthcare Products Regulatory Agency contributes £22,017 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of five months full pay/five months half pay
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
• Civil Service Pension Scheme. Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join the Civil Service Motoring Associati]]>