Job summary

We are currently looking for aDeputy Director Scientific Data & Insightto join ourScientific Data & Insight functionwithin theSafety and Surveillance group.

This is afull-timeopportunity, on apermanentbasis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU. Please be aware that this role can only be worked in the UK and not overseas. �

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.

Who are we?�

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.��

To deliver effectively on our central mission of protecting public health, we need robust vigilance processes that are able to quickly detect, monitor and evaluate safety signals across the product lifecycle, the ability to critically evaluate the benefit/risk balance of signals of concern and design effective risk mitigations, to communicate effectively to patients and the public and a healthcare system able to implement them.� The Safety and Surveillance 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 delivered via the common vigilance platform SafetyConnect.

Job description

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.

In support of this mission, the Scientific Data & Insight function is responsible for developing expertise in house to deliver evidence to underpin these new approaches. Quality and speed of regulatory decision making is dependent on having access to high-quality, representative data in a timely fashion but also being able to access and analyse in house data and information in the most effective way.

The post holder will lead on the development of innovative approaches to support more definitive and timely regulatory decisions with the scale, scope and volume of healthcare and related data, which is available, including increasingly from the patients themselves.� The post holder will have responsibility for addressing data needs for both medicines and devices as well as considering how to better link new data sources to support a holistic view of any safety signal and be responsible for defining when and where the regulatory system can have confidence in the evidence derived from real world data sources. Key aspects of the role include leadership and delivery of the MHRA�s Data Strategy, which sets out our vision for data and real-world evidence, and engagement with our Centres of Excellence in Regulatory Science and Innovation.

To support this the post holder will develop routes to access data which is challenging and will be required to work collaboratively across continents and sectors to ensure co-ordination rather than duplication. The post holder will also have the responsibility for supporting data needs across the medical product life cycle including novel access approaches and is also increasingly recognised that new analytical approaches such as AI and Machine learning are an equal partner in data science going forward. Extensive collaborative working with our Digital & Technology Group will be an important element of the role.

Working collaboratively across the UK and international health data ecosystem will be a key requirement to maximise regulatory access to data but also influence the strategic developments in the health data space for both devices and medicines.

A critical aspect of this work will include the exploration and application of new analytical methodologies including AI and machine learning methods such as natural language processing, large language models and computer modelling and simulation approaches. Hence developing and strengthening capacity and capability in data science within MHRA is a key strategic objective to ensure we are best placed to address the future evidence generation needs for both medicines and devices.

Key Responsibilities

Provide inspirational, effective and consistent leadership to drive increased capability and capacity in data resources for both medicines and devices, from implementation through to completion and evaluation Proactively engage with other national and international bodies to maximise opportunities for use of real-world data in regulatory decisions Represent the MHRA nationally and internationally including membership of a range of national strategic boards and steering groups, proactively shaping and influencing national developments Work interactively across the Safety and Surveillance groups to improve analytical capabilities of existing data resources Support the development of a regulatory framework for software enabled medical devices, other artificial intelligence approaches and digital health products Provide strategic and technical leadership in AI and ML approaches in the context of medical product regulation Work with the Director of CPRD to maximise opportunities to leverage this valuable resource Support evidence generation needs across the medical product life cycle such as new innovative access mechanisms Leadership and coordination of the delivery plan of the MHRA data strategy to ensure the strategic objectives are achieved Coordinating horizon scanning on innovation and developing capacity to support innovators and anticipate and respond to future regulatory challenges Managing expenditure budgets and responding to press office, Department of Health and Social Care (DHSC), patient and public enquiries where necessary� Provide effective leadership and management to the Scientific Data and Insight team, to develop staff in line with the Agency�s people and HR strategies and build and inclusive culture of high and continuous performance. Working collaboratively with the Senior leadership team of S&S to support delivery of the strategic objectives of the group Working in partnership with other Groups in the Agency, to identify, develop and deliver cross-Agency activities such as supporting Innovation, advice-giving and other activities to be identified including developing and agreeing suitable resourcing plans. Where necessary, identifying and developing grant proposals to seek external funding for specific projects. Contribute proactively to the Agency�s plans to continuously improve patient and public involvement in its work across all parts of the regulatory journey.

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Person specification

A strong and inclusive corporate and team leader, experience in the management of professional qualified staff, confident in both people leadership and policy development in an operational context, with the gravitas to earn the respect of stakeholders. Highly developed interpersonal and influencing skills, and the credibility and ability to build excellent relationships and networks with key stakeholders across organisational boundaries Demonstrable track record of AI/ML research Knowledge and understanding of working in a regulatory environment would be an advantage but is not essential. Degree or equivalent qualification in a relevant discipline data science, computer science, medical engineering, toxicology, medical physics, biomaterials or healthcare professional qualification or equivalent qualifications or equivalent experience A sound understanding and ability to oversee the development of databases and data visualisation solutions Knowledge of health data and epidemiological methods is desirable but not essential.

If you would like to find out more about this fantastic opportunity,

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Benefits

Alongside your salary of �76,000, Medicines and Healthcare Products Regulatory Agency contributes �22,017 towards you being a member of the Civil Service Defined Benefit Pension scheme. 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 five months full pay/five months half pay�Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil ServiceCivil Service Pension Scheme.� Please see the link for further information For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on �Flexible working to ensure staff maintain a healthy work-life balance�Interest free season ticket loan or bike loan�Employee Assistance Services and access to the Civil Service Benevolent Fund�Eligibility to join the Civil Service Motoring Association (CSMA)Variety of staff and Civil Service clubs�On-going learning and development�