Description
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.
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. 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.
Key Responsibilities:
- 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 MHRA's 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.
- 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.
- 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.
- 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.
- 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.
- Support the development of future regulatory policy, guidance and frameworks relating to AI-enabled technologies.
- Identify opportunities to strengthen the MHRA's 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.
Requirements:
- 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.
- 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 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.