Head of Gene Therapy in London

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.

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!

Closing date: 26th January

Shortlisting date: from 2nd February

Interview date: from 16th February