Head of Gene Therapy

Overview

Head of Gene Therapy to join the Biotherapeutics and Advanced Therapies Function within the Research and Development group. This is a full-time role on a fixed-term contract until 19 February 2027. The role is based in South Mimms, Hertfordshire.

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

The role will lead a team of expert scientists to address prioritised regulatory scientific research focused on safety, characterisation and accelerated regulatory approval of gene therapy medicines. The post-holder will establish and foster nationally and internationally important research collaborations and liaise with colleagues in Standards Lifecycle and Control Testing Functions, as well as licensing colleagues in HQA and Safety and Surveillance Divisions.

They will apply their highly specialist scientific knowledge to improve efficiencies and optimise Agency activities to bring new and innovative medicines to UK patients.

• Contribute to the development of a research portfolio related to the standardisation and safety of gene therapy medicines and build capability and resilience in future gene therapy standardisation.
• Initiate and drive gene therapy research activities resulting in publishable data and external grant funding; identify potential income sources and apply for external funding for specialist projects.
• Ensure project deliverables and internal objectives are met; undertake general project administration including financial monitoring and reporting; monitor effectiveness and support policy improvements.
• Maintain and disseminate up-to-date knowledge around gene therapy research and standardisation; engage with national and international gene therapy communities to develop and disseminate best practices; represent the Group and the Agency at conferences and meetings.
• Work within the required quality framework (e.g., ISO 13485, ISO 34); write, review and maintain quality records, production records and reports, SOPs, COSHH and risk assessments.
• Collaborate effectively with Agency colleagues (including Standards Lifecycle, British Pharmacopeia and Licensing) to provide expert scientific advice and practical support, and liaise with external collaborators.

Our successful candidate will have:

• PhD in molecular biology, virology, genetics or immunology, with strong 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 procedures for product potency and efficacy quality control
• Internationally competitive track record in gene therapy research and development and experience of securing resources

Method of assessment: A = Application, I = Interview, P = Presentation. Behaviour, Experience and Technical criteria are used in the selection process. See below for the criteria used in assessment.

• 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 procedures for product potency and efficacy quality control (I, P); internationally competitive track record (A); standardisation and medicines control under a QMS (A, I); practical experience in biological lab techniques (I, P)
• Technical Criteria:
  PhD in molecular biology, virology, genetics or immunology with post-doctoral experience (A, I, P)

Closing date: 26 January. Shortlisting from 2 February. Interview from 16 February. If you need adjustments during the process, contact  The agency may require pre-employment checks and security clearances. See the full job posting for details on eligibility and selection principles.