Head, AI for Medicines Safety
Job summary
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This is an exciting opportunity to play a key role in the delivery of the MHRA'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.
Reporting to the Deputy Direct of Benefit Risk Evaluation I, the postholder will provide overall leadership for the programme, including its strategic vision, scientific direction and delivery priorities. The role requires a leader who can operate at the intersection of regulatory science, artificial intelligence, medicines development and patient safety, bringing together expertise from across the MHRA, academia, industry, government and the wider healthcare ecosystem.
The Head, AI for Medicine Safety will be accountable for ensuring that programme activities are scientifically and technically robust, and aligned with the MHRA strategic objectives.
Main duties of the job
The postholder will act as the senior ambassador for the programme, building partnerships nationally and internationally, influencing emerging regulatory thinking, and helping position the MHRA as a global leader in AI-enabled regulation and patient safety science.
Initially focused on leading delivery of the Beyond ADMET: AI for Medicines Safety regulatory sandbox programme, the postholder will also contribute to the MHRA's broader strategic ambitions in AI-enabled regulatory science and innovation, with opportunities to apply their expertise across other priority areas as organisational needs evolve.
Recognising the breadth of expertise required across artificial intelligence, medicines development and safety science, the postholder will lead a multidisciplinary team including technical and regulatory specialists, and programme delivery staff, ensuring the programme benefits from complementary expertise across all domains.
The role offers a unique opportunity to contribute to the advancement of regulatory science at the intersection of AI, medicines development and patient safety, while helping to establish a coherent approach across the MHRA's wider portfolio of AI initiatives and regulatory sandboxes.
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
Strategic Leadership
- Provide overall leadership and strategic direction for the Beyond ADMET: AI for Medicines Safety regulatory sandbox.
- Lead delivery of the programme's strategic priorities, ensuring alignment with the MHRAs strategy and wider government ambitions for AI and life sciences.
- Serve as the senior leader for the programme, ensuring delivery of agreed outcomes, benefits and impact.
- Identify future opportunities for innovation, collaboration and capability development across the AI for Safety portfolio.
Scientific and Technical Leadership
- Act as the senior scientific and technical leader for the programme, ensuring activities are grounded in robust evidence and scientific excellence.
- Provide expert leadership across areas such as artificial intelligence, machine learning, computational modelling, pharmacology, toxicology, healthcare data science, drug development and regulatory science.
- Guide the evaluation of emerging technologies, methodologies, datasets and validation frameworks relevant to regulatory decision-making.
- Ensure programme outputs generate meaningful evidence that can inform future regulatory approaches, guidance and policy.
- Promote innovation while ensuring appropriate standards of quality, transparency, safety and governance.
Programme Oversight and Governance
- Oversee delivery of the programme through effective governance, assurance and performance management arrangements.
- Lead programme boards, steering groups and governance forums.
- Ensure risks, issues, dependencies and opportunities are identified and managed appropriately.
- Oversee programme resources and budgets, ensuring value for money and effective use of public resources.
- Work closely with the Technical Lead, Programme Manager, and Regulation & Policy Lead to ensure effective operational delivery against agreed objectives and milestones.
Stakeholder Engagement and External Leadership
- Build and maintain strong strategic relationships across industry, academia, government, healthcare organisations, patient groups and international regulatory networks.
- Represent the MHRA as a senior spokesperson and thought leader on AI-related regulatory science initiatives.
- Lead engagement with senior external stakeholders to promote collaboration and maximise programme impact.
- Champion dissemination of programme findings, learning and best practice.
- Foster strong connections across the MHRA's wider portfolio of AI initiatives and regulatory sandboxes
People Leadership
- Lead and develop a high-performing multidisciplinary team.
- Create an inclusive culture that encourages innovation, collaboration and continuous improvement.
- Manage senior staff, including technical leadership roles and programme management resource.
Regulatory Science and Organisational Impact
- Support the development of future regulatory policy, guidance and frameworks relating to AI-enabled technologies.
- Identify opportunities to strengthen the MHRAs capability in AI, advanced analytics and regulatory science.
- Contribute to wider MHRA strategic priorities including evidence-based regulatory decision-making and improvements in patient safety.
- Promote the MHRA's reputation as an international leader in innovative regulation.
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 leadership and 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
Technical Criteria
- Recognised expertise in either:
- Artificial Intelligence, Machine Learning, Data Science or Computational Modelling; or
- Pharmacology, Toxicology, Drug Development, NAMs or related life science disciplines.
- Broad understanding of the wider AI and medicines development ecosystem, with the ability to lead multidisciplinary teams spanning both domains.
- Ability to evaluate scientific evidence and emerging technologies and translate findings into regulatory and strategic recommendations.
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.
Experience
- Experience leading complex strategic programmes, scientific portfolios or major innovation initiatives, and successful delivery of their outcomes.
- Experience managing multidisciplinary teams and leading highly specialised technical experts.
- Experience influencing senior stakeholders, operating effectively across organisational boundaries and working collaboratively with external partners including academia, industry, government and healthcare organisations.
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