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.

Person Specification

Experience

• Significant experience and recognised expertise in at least one of the following areas:
• Artificial Intelligence and Machine Learning
• Healthcare data science and computational modelling
• Pre-clinical assessment, toxicology and New Approach Methodologies (NAMs)
• Pharmacology, drug discovery or development or related scientific areas.
• Experience applying scientific and technical expertise to complex regulatory, healthcare, research or industry challenges; and evaluating scientific evidence and translating findings into practical recommendations and actions.
• Experience working with multidisciplinary teams involving scientific, technical and non-technical stakeholders, and engaging effectively with external stakeholders, including academia, industry and research organisations.
• Experience preparing technical reports, scientific assessments, briefings, publications or regulatory submissions.
• Experience of AI model development, validation or deployment within healthcare or life sciences settings, or of ADMET prediction, computational toxicology, modelling and simulation or related disciplines.

Technical Criteria

• Recognised technical expertise in either:
• Pharmacology, Toxicology, Drug Development, Safety Science, New Approach Methodologies (NAMs) or related disciplines, OR
• Artificial Intelligence, Machine Learning, Healthcare Data Science, or related disciplines
• Ability to critically evaluate scientific evidence, AI methodologies, model performance and validation approaches.
• Strong analytical skills and the ability to interpret complex scientific, technical and data-driven information.
• Excellent written and verbal communication skills, including the ability to communicate highly technical concepts to diverse audiences.

Qualifications

• Degree in a relevant scientific, technical or healthcare discipline (or equivalent experience).
• Postgraduate qualification (MSc, PhD or equivalent experience) in a relevant field such as artificial intelligence, computational biology, pharmacology, toxicology, data science, bioinformatics, pharmaceutical sciences or a related discipline.

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

United Kingdom

Employer's website

https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency