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.
Job description
Job responsibilities
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.
Job description
Job responsibilities
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
Experience
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.
- Experience of and enthusiasm for patient safety.
- Experience in pre-clinical assessment, toxicology, genomics or diagnostics.
Desirable
- Experience of acting within regulations to mitigate risks to patients
Qualifications
Essential
- Post-graduate qualifications in relevant clinical, healthcare, scientific, technical or broader health disciplines or equivalent experience/knowledge is essential.
Skills
Essential
- Highly developed communication skills gained through experience of working with senior level stakeholders and influencing the agendas of others.
Knowledge
Essential
- 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.
Person Specification
Experience
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.
- Experience of and enthusiasm for patient safety.
- Experience in pre-clinical assessment, toxicology, genomics or diagnostics.
Desirable
- Experience of acting within regulations to mitigate risks to patients
Qualifications
Essential
- Post-graduate qualifications in relevant clinical, healthcare, scientific, technical or broader health disciplines or equivalent experience/knowledge is essential.
Skills
Essential
- Highly developed communication skills gained through experience of working with senior level stakeholders and influencing the agendas of others.
Knowledge
Essential
- 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.
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.
