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- Tasks: Lead innovative gene therapy research and drive global standardisation efforts.
- Company: Join the Medicines and Healthcare products Regulatory Agency, enhancing health through science.
- Benefits: Full-time role with a competitive salary and opportunities for professional growth.
- Why this job: Make a real impact on the future of gene therapies and patient safety.
- Qualifications: PhD in relevant fields with extensive experience in gene therapy and regulatory processes.
- Other info: Collaborate with top scientists and contribute to groundbreaking research.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
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!
Head of Gene Therapy employer: Medicines and Healthcare Products Regulatory Agency
Contact Detail:
Medicines and Healthcare Products Regulatory Agency Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Gene Therapy
✨Network Like a Pro
Get out there and connect with folks in the gene therapy field! Attend conferences, join relevant online forums, and don’t be shy about reaching out to people on LinkedIn. We all know that sometimes it’s not just what you know, but who you know!
✨Show Off Your Expertise
When you get the chance to chat with potential employers or colleagues, make sure to highlight your experience and knowledge in gene therapy. Share your past projects and how they align with the role. We want to see your passion and expertise shine through!
✨Prepare for Interviews
Do your homework before any interview! Research the company, understand their current projects, and think about how your skills can contribute. We recommend practising common interview questions related to gene therapy to boost your confidence.
✨Apply Through Our Website
Don’t forget to apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to engage with us directly.
We think you need these skills to ace Head of Gene Therapy
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your application to highlight how your experience aligns with the role of Head of Gene Therapy. Use keywords from the job description to show that you understand what we're looking for.
Showcase Your Expertise: Don’t hold back on sharing your extensive experience in gene therapy and related fields. We want to see your track record, so include specific examples of your work that demonstrate your skills and achievements.
Be Clear and Concise: When filling out the application form, keep your answers clear and to the point. Avoid jargon unless it’s relevant, and make sure every sentence adds value to your application. We appreciate straightforward communication!
Apply Through Our Website: Remember to submit your application through our website. It’s the best way to ensure it gets to us without any hiccups. Plus, you’ll find all the details you need right there!
How to prepare for a job interview at Medicines and Healthcare Products Regulatory Agency
✨Know Your Stuff
Make sure you brush up on the latest advancements in gene therapy, molecular biology, and related fields. Be prepared to discuss your post-doctoral experience and how it aligns with the role. This shows that you're not just knowledgeable but also genuinely interested in the field.
✨Showcase Your Leadership Skills
As a Head of Gene Therapy, you'll be leading a team of expert scientists. Prepare examples of how you've successfully led projects or teams in the past. Highlight your ability to foster collaboration and drive research activities, as this will be key in your new role.
✨Prepare for Behavioural Questions
Expect questions around delivering at pace and working together. Think of specific instances where you've demonstrated these behaviours. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
✨Engage with the Community
Be ready to discuss how you plan to engage with the national and international gene therapy community. Mention any previous collaborations or conferences you've attended. This shows your commitment to staying connected and contributing to the field beyond your immediate role.
