Head, AI for Medicines Safety - £75,585 - £84,840 p.a. + benefits at Medicines and Healthcare Products Regulatory Agency in 10 South Colonnade, Canary Wharf London, E14 4PU.

Job summary

We are currently looking for a Head, AI for Medicines Safety to join our Benefit Risk Evaluation I Function within the Safety & Surveillance Group.

This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

The Safety and Surveillance (S&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.

Against this background and the drive to improve treatment availability for patients, safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways.

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. 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:

• Signal detection of emerging safety issues
• Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures
• Using data and embracing new technologies to develop the evidence to support our actions and understand their impact

Job description

Role Purpose

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. 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.

Key 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 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.

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 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.

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

Essential Criteria:

• 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.
• 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.

Behaviours

We'll assess you against these behaviours during the selection process:

• Communicating and Influencing
• Leadership
• Delivering at Pace

Technical skills

We'll assess you against these technical skills during the selection process:

• 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.
• 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.

We only ask for evidence of these technical skills on your application form:

• Recognised expertise in either:

Artificial Intelligence, Machine Learning, Data Science or Computational Modelling; or

Pharmacology, Toxicology, Drug Development, NAMs or related life science disciplines.

Benefits

Alongside your salary of £75,585, Medicines and Healthcare Products Regulatory Agency contributes

£21,896 towards you being a member of the Civil Service Defined Benefit Pension scheme.

Find out what benefits a Civil Service Pension provides (opens in a new window).

• 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. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of six months full pay and six months hal