NHS
Head of Biosafety, Non-clinical and Emerging Technologies
This job is now closed
Job Description
- Req#: K0015-25-0000?language=en&page=402&sort=publicationDateDesc
- 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.
- 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.
- 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.
- Experience of and enthusiasm for patient safety.
- Experience in pre-clinical assessment, toxicology, genomics or diagnostics.
- Experience of acting within regulations to mitigate risks to patients
- Post-graduate qualifications in relevant clinical, healthcare, scientific, technical or broader health disciplines or equivalent experience/knowledge is essential.
- Highly developed communication skills gained through experience of working with senior level stakeholders and influencing the agendas of others.
- 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.
- Understanding of the regulatory framework(s) and/or ability to acquire such knowledge quickly.
- 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.
- Experience of and enthusiasm for patient safety.
- Experience in pre-clinical assessment, toxicology, genomics or diagnostics.
- Experience of acting within regulations to mitigate risks to patients
- Post-graduate qualifications in relevant clinical, healthcare, scientific, technical or broader health disciplines or equivalent experience/knowledge is essential.
- Highly developed communication skills gained through experience of working with senior level stakeholders and influencing the agendas of others.
- 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.
- Understanding of the regulatory framework(s) and/or ability to acquire such knowledge quickly.
Job summary
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.
Main duties of the job
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.
About us
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.
Details
Date posted
23 June 2025
Pay scheme
Other
Salary
£76,000 a year
Contract
Permanent
Working pattern
Full-time, Flexible working
Reference number
K0015-25-0000
Job locations
Medicine & Healthcare Regulatory Agency
10 South Colonnade
London
E14 4PU
Job descriptionJob description
Job responsibilities
Key responsibilities:
Job responsibilities
Key responsibilities:
Person SpecificationPerson Specification
Experience
Essential
Desirable
Qualifications
Essential
Skills
Essential
Knowledge
Essential
Experience
Essential
Desirable
Qualifications
Essential
Skills
Essential
Knowledge
Essential
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details
Employer name
Medicines and Healthcare Products Regulatory Agency
Address
Medicine & Healthcare Regulatory Agency
10 South Colonnade
London
E14 4PU
Employer's website
Employer details
Employer name
Medicines and Healthcare Products Regulatory Agency
Address
Medicine & Healthcare Regulatory Agency
10 South Colonnade
London
E14 4PU
Employer's website
About the company
National Health Service (NHS) is the umbrella term for the publicly-funded healthcare systems of the United Kingdom (UK). The founding principles were that services should be comprehensive, universal and free at the point of delivery—a health service based on clinical need, not ability to pay. Each service provides a comprehensive range of health services, free at the point of use for people ordinarily resident in the United Kingdom apart from dental treatment and optical care.
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