Technical Lead, Medicines Safety Technologies

Job description

Job responsibilities

Technical Leadership

• Serve as a senior technical and scientific leader for the Beyond ADMET: AI for Medicines Safety regulatory sandbox, providing specialist expertise and advice to support the delivery of programme objectives.
• Provide technical oversight of project activities, ensuring scientific rigour, technical quality and alignment with objectives.
• Evaluate emerging AI methodologies, models, datasets and validation approaches relevant to medicines development, safety assessment and regulatory decision-making.
• Provide expert input into the design, delivery and evaluation of sandbox activities and use cases.
• Support the identification of scientific opportunities, risks, uncertainties and limitations associated with AI-enabled approaches.
• Contribute to the development of evidence, recommendations and outputs arising from the programme.

Programme Delivery

• 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.
• Coordinate technical workstreams and ensure effective integration of scientific, technical and regulatory activities across the programme.
• Monitor technical deliverables and milestones, identifying risks, issues and dependencies and proposing appropriate mitigations.
• Reports, briefings and presentations.
• Ensure programme outputs are translated into meaningful regulatory and scientific outcomes.

Stakeholder Engagement

• Build and maintain strong working relationships with technical experts across the MHRA, industry, academia, government departments and the wider healthcare and life sciences sectors.
• Act as a technical representative for the programme at meetings, workshops, conferences and stakeholder engagement events.
• Collaborate with external experts to understand current scientific developments, emerging technologies and international best practice.
• Support engagement with other AI-focused programmes and regulatory sandboxes across the MHRA to encourage consistency, learning and knowledge sharing.
• Work closely with communications and stakeholder engagement colleagues to support dissemination of programme findings and outputs.
• Deputise for the Head, AI for Safety at meetings, workshops and stakeholder engagements as required.

Regulatory Science and Innovation

• Support the development of strategic capability in AI-enabled regulatory science across the MHRA and contribute expertise to wider Agency initiatives where appropriate.
• Support the development of future regulatory frameworks, guidance and policy relating to AI-enabled technologies where appropriate.
• Keep abreast of developments in AI, computational toxicology, pharmacology, modelling and simulation, healthcare data science and related fields.
• Identify opportunities to strengthen scientific capability and further develop the MHRA's leadership in AI-enabled regulation.

Quality and Governance

• Ensure technical activities are delivered in accordance with MHRA governance, quality management and best practice requirements.
• Maintain accurate records, documentation and evidence to support programme outputs and decision-making.

General

• 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 provide scientific and technical expertise across the Agency's evolving AI, data and regulatory science agenda.
• Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.
• Proactively maintain and develop professional knowledge and expertise, sharing learning and best practice with colleagues.
• Demonstrate flexibility and adaptability in response to emerging technologies, scientific developments and changing business needs.

Job responsibilities

Technical Leadership

• Serve as a senior technical and scientific leader for the Beyond ADMET: AI for Medicines Safety regulatory sandbox, providing specialist expertise and advice to support the delivery of programme objectives.
• Provide technical oversight of project activities, ensuring scientific rigour, technical quality and alignment with objectives.
• Evaluate emerging AI methodologies, models, datasets and validation approaches relevant to medicines development, safety assessment and regulatory decision-making.
• Provide expert input into the design, delivery and evaluation of sandbox activities and use cases.
• Support the identification of scientific opportunities, risks, uncertainties and limitations associated with AI-enabled approaches.
• Contribute to the development of evidence, recommendations and outputs arising from the programme.

Programme Delivery

• 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.
• Coordinate technical workstreams and ensure effective integration of scientific, technical and regulatory activities across the programme.
• Monitor technical deliverables and milestones, identifying risks, issues and dependencies and proposing appropriate mitigations.
• Reports, briefings and presentations.
• Ensure programme outputs are translated into meaningful regulatory and scientific outcomes.

Stakeholder Engagement

• Build and maintain strong working relationships with technical experts across the MHRA, industry, academia, government departments and the wider healthcare and life sciences sectors.
• Act as a technical representative for the programme at meetings, workshops, conferences and stakeholder engagement events.
• Collaborate with external experts to understand current scientific developments, emerging technologies and international best practice.
• Support engagement with other AI-focused programmes and regulatory sandboxes across the MHRA to encourage consistency, learning and knowledge sharing.
• Work closely with communications and stakeholder engagement colleagues to support dissemination of programme findings and outputs.
• Deputise for the Head, AI for Safety at meetings, workshops and stakeholder engagements as required.

Regulatory Science and Innovation

• Support the development of strategic capability in AI-enabled regulatory science across the MHRA and contribute expertise to wider Agency initiatives where appropriate.
• Support the development of future regulatory frameworks, guidance and policy relating to AI-enabled technologies where appropriate.
• Keep abreast of developments in AI, computational toxicology, pharmacology, modelling and simulation, healthcare data science and related fields.
• Identify opportunities to strengthen scientific capability and further develop the MHRA's leadership in AI-enabled regulation.

Quality and Governance

• Ensure technical activities are delivered in accordance with MHRA governance, quality management and best practice requirements.
• Maintain accurate records, documentation and evidence to support programme outputs and decision-making.

General

• 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 provide scientific and technical expertise across the Agency's evolving AI, data and regulatory science agenda.
• Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.
• Proactively maintain and develop professional knowledge and expertise, sharing learning and best practice with colleagues.
• Demonstrate flexibility and adaptability in response to emerging technologies, scientific developments and changing business needs.