Head of Therapy - £60,778 p.a. + benefits

Job summary

We are currently looking for a Head of Gene Therapy to join our Biotherapeutics and Advanced Therapies Function within the Research and Development group.

This is a full-time opportunity, on a fixed term contract basis until 19th February 2027. The role will be based in South Mimms, Hertfordshire.

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.

The research and development function of the MHRA Science Campus comprises a multi-disciplinary team of internationally respected scientists who deliver strategically aligned regulatory scientific research focused on the development and distribution of biological reference materials.

The Gene Therapy team aims to impact the future safety and quality of gene therapies through addressing regulatory focused research questions and by driving the global harmonisation of gene therapy critical quality attribute assessment, underpinned by the development and application of new physical standards.

What’s the role?

This post has the global role of developing and executing a programme of research & development for the standardisation and safety of gene therapy medicines. The post-holder is expected to deliver on existing projects, to actively contribute to other ongoing gene therapy projects across the group and to support the development of new projects through applications for externally funded research projects.

The role will lead a team of expert scientists to address prioritised regulatory scientific research focused on the safety, characterisation and accelerated regulatory approval of gene therapy medicines.

The role will establish and foster strategically important National and International research collaborations and will also liaise closely with scientists in Standards Lifecycle and Control Testing Functions as well as licensing colleagues in HQA and Safety and Surveillance Divisions. Aligned to effective communication and collaboration, the postholder will apply their highly specialist scientific knowledge in gene therapy products to improve efficiencies and optimise Agency activities to bring new and innovative medicines to UK patients.

Job description

Key responsibilities:

• Contribute to the development of a research portfolio of projects related to the standardisation and safety of gene therapy medicines and build up capability and resilience in future gene therapy standardisation area.

• Initiate and drive gene therapy research activities, which result in scientific data that is publishable in high quality scientific journals and attracts sustained external grant funding. Identify potential sources of income generation and apply for external grant funding for specialist projects.

• Assure that project deliverables and internal objectives are met. Undertake general project administration for the projects, including financial monitoring and reporting. Monitor the effectiveness of the activities, identify areas of improvement and support implementation of new policies.

• Maintain and disseminate up-to-date knowledge around gene therapy research and standardisation. Work with the national and international gene therapy community to develop and disseminate good practices. Represent the Group and the Agency at national and international conferences and other relevant meetings/workgroups as appropriate.

• Work within the required quality framework (e.g. ISO 13485, ISO 34). Write, review and maintain quality records, including the generation of production records and reports, standard operating procedures, COSHH and risk assessments.

• Work closely and communicate effectively with Agency colleagues as required (including Standards Lifecycle, British Pharmacopeia and Licensing) to provide expert scientific advice and practical support as well as with external collaborators.

Who are we looking for?

Our successful candidate will have:

• PhD in molecular biology, virology, genetics or immunology, with strong and relevant post-doctoral experience

• Extensive experience in gene therapy, molecular biology, virology, genetics and immunology

• Experience or interest in standardisation, medicines control and working under a Quality Management System

• Experience in developing and applying innovative technical procedures for product potency and efficacy quality control

• Internationally competitive track record in gene therapy research and development and experience of securing resources

Person specification

Method of assessment: A=Application, I=Interview, P=Presentation

Behaviour Criteria:

• Delivering at Pace (A, I)

• Working Together (A, I)

• Communicating and Influencing (I)

Experience Criteria:

• Extensive experience in gene therapy, molecular biology, virology, genetics, and immunology (A, I, P)

• Experience in developing and applying innovative technical procedures for product potency and efficacy quality control (I, P)

• Internationally competitive track record in gene therapy research and development and experience of securing resources (A)

• Experience or interest in standardisation and medicines control and in working under a Quality Management System (A, I)

• In-depth practical experience in a broad range of relevant biological laboratory techniques, including cell culture and molecular biology (I, P)

Technical Criteria:

• PhD in molecular biology, virology, genetics or immunology, with strong and relevant post-doctoral experience (A, I, P)

Strengths Criteria

• Analytical (I)

If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification!

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Benefits

Alongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

• 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 Service
• Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
• 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

Things you need to know

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

We use the Civil Service Success Profiles to assess our candidates, find out more here.

• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.

• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.

• Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of Experience or interest in standardisation and medicines control and in working under a Quality Management System.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

Closing date: 26th January

Shortlisting date: from 2nd February

Interview date: from 16th February

If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens

• Maintenance roles, particularly those required to work in laboratory settings

• Roles that involve visiting other establishments where vaccination is required

• Roles required to travel overseas where specific vaccination may be required.

Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : Careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should contact the Resourcing Team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ