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These functions are supported by the Agency’s data and evidence generating capabilities, complementing our signal generating abilities.</p>\n<p>The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience.</p>\n<p><strong>Role Purpose</strong></p>\n<p>This is an exciting opportunity to play a senior technical leadership role in the MHRA&#39;s pioneering regulatory sandbox, “Beyond ADMET: AI for Medicines Safety”, an innovative initiative exploring how artificial intelligence can transform medicines development and strengthen patient safety.</p>\n<p><strong>Key Responsibilities</strong></p>\n<ul>\n<li>Provide senior scientific and technical leadership for the “Beyond ADMET: AI for Medicines Safety” Sandbox programme, ensuring programme activities are scientifically robust, technically credible and aligned with regulatory objectives.</li>\n<li>Work in partnership with the Head, AI for Medicines Safety to ensure the programme benefits from complementary expertise across artificial intelligence, healthcare data science, toxicology, pharmacology, medicines development and regulatory science.</li>\n<li>Lead the evaluation of emerging methodologies, technologies, datasets and evidence relevant to AI-enabled medicines development, safety assessment and regulatory decision-making.</li>\n<li>Build and maintain strong relationships with experts across the MHRA, industry, academia and government, representing the programme through technical engagement, collaboration and thought leadership activities.</li>\n</ul>\n<p><strong>Benefits</strong></p>\n<p>Alongside your salary of £78,230, Medicines and Healthcare Products Regulatory Agency contributes £22,663 towards you being a member of the Civil Service Defined Benefit Pension scheme.</p>\n<ul>\n<li>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. 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The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.</p>\n<p>The Safety and Surveillance (S&amp;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.</p>\n<p>The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience.</p>\n<p>The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for:</p>\n<ul>\n<li>Signal detection of emerging safety issues</li>\n<li>Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures</li>\n<li>Using data and embracing new technologies to develop the evidence to support our actions and understand their impact</li>\n</ul>\n<p>This is an exciting opportunity to play a lead regulatory and policy role in the delivery of the MHRA&#39;s “Beyond ADMET: AI for Medicines Safety” regulatory sandbox. This unique regulatory science initiative will explore how artificial intelligence can improve the prediction of absorption, distribution, metabolism, excretion and toxicity (ADMET) outcomes and integrate clinical and real-world data to support safer, faster and more efficient medicines development.</p>\n<p>Working closely with the Head, AI for Medicines Safety and the Technical Lead, the postholder will provide specialist regulatory and policy expertise across the programme, ensuring that sandbox activities are aligned with current regulatory frameworks and helping to assess the implications of emerging AI-enabled approaches for medicines development and safety assessment.</p>\n<p>The postholder will support the identification and interpretation of emerging regulatory, scientific and policy developments relating to artificial intelligence, computational methods and non-clinical medicines development. They will work collaboratively with colleagues across the MHRA, government, industry, academia and international regulatory networks to support evidence generation, regulatory learning and policy development arising from the programme.</p>\n<p>Initially focused on supporting delivery of the “Beyond ADMET: AI for Medicines Safety” regulatory sandbox programme, the postholder will also contribute to the MHRA&#39;s broader ambitions in AI-enabled regulatory science and innovation, with opportunities to apply their expertise across other priority areas as organisational needs evolve.</p>\n<p>The role offers a unique opportunity to contribute to the future development of AI-enabled medicines regulation while helping strengthen the MHRA&#39;s position as a global leader in regulatory innovation and patient safety.</p>\n<p><strong>Key responsibilities</strong></p>\n<p><strong>Regulatory and Policy Leadership</strong></p>\n<ul>\n<li>Lead on all aspects of regulatory and policy advice on AI-enabled approaches in medicines development, safety assessment and related scientific areas.</li>\n<li>Shape the MHRA&#39;s regulatory thinking on emerging AI methodologies and technologies, ensuring outputs from the sandbox inform future regulatory approaches and policy development.</li>\n<li>Lead the interpretation and application of current legislation, regulatory frameworks and guidance relevant to programme activities.</li>\n</ul>\n<p><strong>Programme Delivery</strong></p>\n<ul>\n<li>Work closely with the Head, AI for Medicines Safety, Technical Lead and Programme Manager to ensure effective integration of regulatory, scientific and operational considerations across the programme.</li>\n<li>Provide regulatory and policy leadership on programme planning, delivery and evaluation activities.</li>\n<li>Develop programme outputs including reports, recommendations, briefings, workshops and publications.</li>\n</ul>\n<p><strong>Stakeholder Engagement</strong></p>\n<ul>\n<li>Build effective relationships with stakeholders across the MHRA, government departments, academia, industry, healthcare organisations and international regulatory networks.</li>\n<li>Represent the programme in regulatory and policy discussions with internal and external stakeholders, communicating regulatory and policy considerations clearly to technical and non-technical audiences.</li>\n</ul>\n<p><strong>Regulatory Science and Governance</strong></p>\n<ul>\n<li>Lead on the development of future regulatory frameworks, guidance and policy approaches where appropriate.</li>\n<li>Ensure regulatory activities are delivered in accordance with MHRA governance requirements, quality standards and best practice.</li>\n</ul>\n<p><strong>General</strong></p>\n<ul>\n<li>While the immediate focus of this role is the successful delivery of the “Beyond ADMET: AI for Medicines Safety” regulatory sandbox, the postholder will be expected to contribute regulatory and policy expertise across the Agency&#39;s evolving AI and regulatory science agenda.</li>\n<li>Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.</li>\n</ul>\n<p><strong>Person specification</strong></p>\n<p><strong>Essential Criteria:</strong></p>\n<ul>\n<li>Experience working in regulatory affairs, regulatory policy, regulatory science or a related discipline within healthcare, life sciences or a related sector - Lead</li>\n<li>Experience interpreting and applying regulatory frameworks to new technologies, scientific approaches, products or services.</li>\n<li>Experience advising on regulatory or policy issues and translating complex information into practical recommendations.</li>\n<li>Experience contributing to regulatory guidance, policy development, standards development or regulatory science initiatives.</li>\n<li>Experience engaging effectively with stakeholders across government, academia, industry, healthcare organisations or regulatory bodies.</li>\n<li>Experience working collaboratively within multidisciplinary projects, programmes or teams.</li>\n</ul>\n<p><strong>Qualifications</strong></p>\n<ul>\n<li>Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).</li>\n</ul>\n<p><strong>Behaviours</strong></p>\n<ul>\n<li>Communicating and Influencing</li>\n<li>Working Together</li>\n<li>Making Effective Decisions</li>\n</ul>\n<p><strong>Technical skills</strong></p>\n<ul>\n<li>Understanding of medicines regulation, non-clinical assessment and emerging technologies.</li>\n<li>Knowledge of regulatory policy development processes and regulatory science principles.</li>\n<li>Ability to critically evaluate scientific evidence and assess regulatory implications.</li>\n<li>Understanding of artificial intelligence and machine learning concepts and their application within healthcare and life sciences.</li>\n<li>Awareness of UK and international regulatory approaches relating to AI-enabled technologies.</li>\n<li>Strong written and verbal communication skills, including preparation of briefings, reports and recommendations for senior audiences.</li>\n</ul>\n<p><strong>Benefits</strong></p>\n<ul>\n<li>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. 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The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.</p>\n<p>The Safety and Surveillance (S&amp;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.</p>\n<p>The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience.</p>\n<p>The team conducts benefit-risk evaluations for medicines and medical devices across a broad spectrum of therapeutic areas to guide actions that protect patient safety.</p>\n<p><strong>Role Purpose</strong></p>\n<p>This is an exciting opportunity to play a key role in the delivery of the MHRA&#39;s “Beyond ADMET: AI for Medicines Safety” regulatory sandbox. This strategic regulatory science initiative will explore how artificial intelligence can improve the prediction of absorption, distribution, metabolism, excretion and toxicity (ADMET) outcomes and integrate clinical and real-world data to support safer, faster and more efficient medicines development, ultimately strengthening patient safety.</p>\n<p>Reporting to the Deputy Director of Benefit Risk Evaluation I, the postholder will provide overall leadership for the programme, including its strategic vision, scientific direction and delivery priorities.</p>\n<p><strong>Key responsibilities</strong></p>\n<ul>\n<li>Provide overall leadership and strategic direction for the “Beyond ADMET: AI for Medicines Safety” regulatory sandbox.</li>\n<li>Lead delivery of the programme&#39;s strategic priorities, ensuring alignment with the MHRA’s strategy and wider government ambitions for AI and life sciences.</li>\n<li>Serve as the senior leader for the programme, ensuring delivery of agreed outcomes, benefits and impact.</li>\n<li>Identify future opportunities for innovation, collaboration and capability development across the AI for Safety portfolio.</li>\n</ul>\n<p><strong>Person specification</strong></p>\n<ul>\n<li>Significant senior leadership experience in one or more relevant disciplines, including: Artificial Intelligence and Machine Learning, Computational modelling, Pre-clinical assessment, toxicology and New Approach Methodologies (NAMs), Pharmacology, drug discovery or development, Healthcare data science or related scientific areas.</li>\n<li>Experience leading complex strategic programmes, scientific portfolios or major innovation initiatives, and successful delivery of their outcomes.</li>\n<li>Experience managing multidisciplinary teams and leading highly specialised technical experts.</li>\n<li>Experience influencing senior stakeholders, operating effectively across organisational boundaries and working collaboratively with external partners including 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development and strengthen patient safety.</p>\n<p>Working alongside the Head, AI for Medicines Safety, you will provide specialist scientific and technical leadership, helping to shape the evidence, methodologies and innovations that inform future regulatory approaches.</p>\n<p><strong>Main duties of the job</strong></p>\n<ul>\n<li>Provide senior scientific and technical leadership for the Beyond ADMET: AI for Medicines Safety Sandbox programme, ensuring programme activities are scientifically robust, technically credible and aligned with regulatory objectives.</li>\n<li>Work in partnership with the Head, AI for Medicines Safety to ensure the programme benefits from complementary expertise across artificial intelligence, healthcare data science, toxicology, pharmacology, medicines development and regulatory science.</li>\n<li>Lead the evaluation of emerging methodologies, technologies, datasets and evidence relevant to AI-enabled medicines development, safety assessment and regulatory 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the identification of scientific opportunities, risks, uncertainties and limitations associated with AI-enabled approaches.</li>\n<li>Contribute to the development of evidence, recommendations and outputs arising from the programme.</li>\n</ul>\n<ul>\n<li><strong>Programme Delivery</strong></li>\n<li>Work in partnership with the Head, AI for Medicines Safety to ensure the programme benefits from complementary expertise across artificial intelligence, medicines development, pharmacology, toxicology, healthcare data science and regulatory science.</li>\n<li>Coordinate technical workstreams and ensure effective integration of scientific, technical and regulatory activities across the programme.</li>\n<li>Monitor technical deliverables and milestones, identifying risks, issues and dependencies and proposing appropriate mitigations.</li>\n<li>Reports, briefings and presentations.</li>\n<li>Ensure programme outputs are translated into meaningful regulatory and scientific outcomes.</li>\n</ul>\n<ul>\n<li><strong>Stakeholder Engagement</strong></li>\n<li>Build and maintain strong working relationships with technical experts across the MHRA, industry, academia, government departments and the wider healthcare and life sciences sectors.</li>\n<li>Act as a technical representative for the programme at meetings, workshops, conferences and stakeholder engagement events.</li>\n<li>Collaborate with external experts to understand current scientific developments, emerging technologies and international best practice.</li>\n<li>Support engagement with other AI-focused programmes and regulatory sandboxes across the MHRA to encourage consistency, learning and knowledge sharing.</li>\n<li>Work closely with communications and stakeholder engagement colleagues to support dissemination of programme findings and outputs.</li>\n<li>Deputise for the Head, AI for Safety at meetings, workshops and stakeholder engagements as required.</li>\n</ul>\n<ul>\n<li><strong>Regulatory 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membership nationally or internationally</li>\n<li>Be a skilled communicator</li>\n<li>Be able to assimilate complex scientific information at short notice; and provide formal and informal advice to the MHRA between meetings when required</li>\n<li>Be prepared to relinquish all personal and non-personal interests of a financial nature in the pharmaceutical industry</li>\n<li>Be recognised by their peers as leaders in their field and/or be Fellows of the relevant Royal Colleges</li>\n</ul>\n<p><strong>Benefits</strong></p>\n<ul>\n<li>£500 a session</li>\n<li>Fixed term contract for 1 year</li>\n<li>Part-time, flexible working, home or remote working</li>\n</ul>\n<p><strong>How to apply</strong></p>\n<p>Please email your application form, CV, completed monitoring form and declaration of interest form to: cstrecruitment@mhra.gov.uk, quoting the position and reference ABRHP26-1 in the subject field.</p>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML job scraping automation by 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frameworks and helping to assess the implications of emerging AI-enabled approaches for medicines development and safety assessment.</p>\n<p><strong>Job Responsibilities:</strong></p>\n<ul>\n<li>Regulatory and Policy Leadership:</li>\n<li>Lead on all aspects of regulatory and policy advice on AI-enabled approaches in medicines development, safety assessment and related scientific areas.</li>\n<li>Shape the MHRA&#39;s regulatory thinking on emerging AI methodologies and technologies, ensuring outputs from the sandbox inform future regulatory approaches and policy development.</li>\n<li>Drive horizon scanning and strategic assessment of UK and international regulatory, policy and scientific developments relevant to AI, toxicology, pharmacology, ADMET prediction and medicines development.</li>\n</ul>\n<ul>\n<li>Programme Delivery:</li>\n<li>Work closely with the Head, AI for Medicines Safety, Technical Lead and Programme Manager to ensure effective integration of regulatory, scientific and operational considerations across the programme.</li>\n<li>Provide regulatory and policy leadership on programme planning, delivery and evaluation activities.</li>\n<li>Develop programme outputs including reports, recommendations, briefings, workshops and publications.</li>\n</ul>\n<ul>\n<li>Stakeholder Engagement:</li>\n<li>Build effective relationships with stakeholders across the MHRA, government departments, academia, industry, healthcare organisations and international regulatory networks.</li>\n<li>Represent the programme in regulatory and policy discussions with internal and external stakeholders, communicating regulatory and policy considerations clearly to technical and non-technical audiences.</li>\n</ul>\n<ul>\n<li>Regulatory Science and Governance:</li>\n<li>Lead on the development of future regulatory frameworks, guidance and policy approaches where appropriate.</li>\n<li>Identify opportunities to strengthen MHRA capability and leadership in AI-enabled regulation.</li>\n<li>Ensure regulatory activities are delivered in accordance with MHRA governance requirements, quality standards and best practice.</li>\n</ul>\n<p><strong>Person Specification:</strong></p>\n<ul>\n<li>Qualifications:</li>\n<li>Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).</li>\n</ul>\n<ul>\n<li>Experience:</li>\n<li>Experience working in regulatory affairs, regulatory policy, regulatory science or a related discipline within healthcare, life sciences or a related sector.</li>\n<li>Experience interpreting and applying regulatory frameworks to new technologies, scientific approaches, products or services.</li>\n<li>Experience advising on regulatory or policy issues and translating complex information into practical recommendations.</li>\n<li>Experience contributing to regulatory guidance, policy development, standards development or regulatory science initiatives.</li>\n<li>Experience engaging effectively with stakeholders across government, academia, industry, healthcare organisations or regulatory bodies.</li>\n<li>Experience working collaboratively within multidisciplinary projects, programmes or teams.</li>\n</ul>\n<ul>\n<li>Technical Criteria:</li>\n<li>Understanding of medicines regulation, non-clinical assessment and emerging technologies.</li>\n<li>Knowledge of regulatory policy development processes and regulatory science principles.</li>\n<li>Ability to critically evaluate scientific evidence and assess regulatory implications.</li>\n<li>Understanding of artificial intelligence and machine learning concepts and their application within healthcare and life sciences.</li>\n<li>Awareness of UK and international regulatory approaches relating to AI-enabled technologies.</li>\n<li>Strong written and verbal communication skills, including preparation of briefings, reports and recommendations for senior audiences.</li>\n</ul>\n<p style=\"margin-top:24px;font-size:13px;color:#666;\">XML 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