Head of Safety and Efficacy of Biologicals
Veterinary Medicines Directorate
Apply before 11:55 pm on Monday 30th September 2024
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About the job
Job summary
We are currently looking for a Head of Safety and Efficacy of Biologicals to join our Biologicals Section within VMD’s Authorisations Group.
This exciting and interesting job puts you at the heart of animal health and welfare in authorising biological/immunological veterinary medicinal products (VMPs) including vaccines in the UK. Your work will play a major role in assuring the quality, safety and efficacy of these medicines and will significantly contribute to VMD’s objective of ensuring the availability of appropriate and innovative biological/immunological VMPs including vaccines to protect animal health and welfare.
You will be responsible for leading the assessment of the safety and efficacy requirements of applications for marketing authorisations for biological/immunological VMPs which are authorised for use in the UK.
Job description
The role of the Head of Safety and Efficacy of Biologicals is to lead and manage the assessors involved in the assessment of safety, efficacy and overall benefit risk of biological VMPs as well as associated work processes, to carry out assessments of certain applications as well as to peer review those carried out by other members of the team. You will be responsible for the continued development and training of assessors in these areas. You will lead on formulation of national and international regulatory policies and guidelines for VMPs including novel therapy VMPs and on the provision of scientific and regulatory advice to applicants and stakeholders. You will lead on VMD’s global cooperation initiatives in regulatory affairs, work-sharing across regulatory jurisdictions, and capacity strengthening. You will report to the Head of the Biologicals Section and deputise for them.
Whilst this role within the Biologicals Section has a focus on safety and efficacy it is expected due to the nature of biological/immunological VMPs that the job holder will be sufficiently experienced to be able to understand the key aspects of quality, safety and efficacy requirements of these VMPs in particular interdependent key attributes that contribute to/ensure the overall quality, safety, efficacy and benefit/risk balance of the product.
The VMD is committed to supporting innovation of biological/immunological veterinary medicinal products including novel therapies VMPs. The post holder will provide expert input into the assessment of safety and efficacy aspects of medicines submitted for authorisations of novel therapies veterinary medicinal products, scientific advice and development of guidance/regulation for these medicines.
The key responsibilities of the roles are:
Leadership:
- Lead, manage and supervise the team of assessors involved in the assessment of safety, efficacy and overall benefit risk of biological VMPs.
- Work with the Head of Biologicals to coordinate the allocation of work and resources to ensure business targets are met efficiently.
- Contribute to the formulation of national and international regulatory policies and guidelines for biological/immunological VMPs including novel therapy VMPs.
- Support the implementation of the Veterinary Medicines Regulations (2013, as amended) and delivery of VMD’s Regulatory Science Strategy (2021-2026).
- As part of the senior leadership team, to contribute to the wider corporate aims and objectives of the VMD including support to the international agenda.
Quality of science:
- Assess certain applications and prepare written assessment reports for marketing authorisations for biological VMPs and clinical field trials in compliance with legislation, guidance and standards. This will include applications for complex and novel therapies VMPs.
- Present these reports to VMD’s formal committee charged with recommending approval or rejection of applications.
- Peer review assessments and assessment reports prepared by the team to ensure the scientific and regulatory quality of the applications progressed by the assessors involved in the safety and efficacy assessment, including compliance with legislation, guidance and standards.
- Provide expert scientific, technical and regulatory support to assessors.
- Develop and update assessment procedures and guidelines.
External engagement:
- Provide and coordinate team scientific and regulatory advice and guidance to applicants and stakeholders.
- Represent the organisation at national and international strategic meetings, committees and conferences.
- Liaise with National and EU industry representative bodies.
- Monitor emerging diseases and any change in the global animal health situation and assess and report on the implications of such changes to the regulatory environment, setting appropriate strategic direction.
- Support VMD’s initiatives for global cooperation, work-sharing across regulatory jurisdictions, and capacity strengthening.
Internal engagement:
- Work collaboratively with other VMD teams for effective regulatory oversight specifically the Pharmaceuticals, Pharmacovigilance, Inspection and Legislation Teams.
- Provide and coordinate team expertise and support to VMD colleagues on safety and efficacy issues, including policy development, suspected adverse reactions, and import certificates.
Developing the Team:
- Cultivate leadership skills, specialisms and awareness of scientific and regulatory developments within the team.
- Plan for and identify assessor’s future skills and training needs, including novel therapies and technologies.
- Provide training and mentoring to enhance team capabilities.
Person specification
You must have significant, relevant experience, gained within the veterinary pharmaceutical industry and/or within a regulatory authority including:
- Extensive knowledge of the GB national legislation relating to the regulation of biological/immunological VMPs including vaccines and/or novel therapies in particular to safety and efficacy requirements although an understanding of quality requirements is also expected.
- An understanding of the EU authorisation processes of biological/immunological VMPs as it applies to Northern Ireland.
- Experience which has given you a thorough working knowledge of biological/immunological VMP development, for example in the pharmaceutical industry in the development and/or manufacturing processes of biological/immunological VMPs.
- Experience in evaluating preclinical and clinical data, conducting risk assessments and interpreting scientific literature.
- Experience in writing and reviewing scientific publications or reports preferably scientific reports relating to the evaluation of quality, safety, efficacy and benefit/risk of biological/immunological VMPs including vaccines.
- Effective communication skills, both written and verbal, with the ability to convey technical information to diverse audiences.
- Excellent analytical skills with the ability to critically evaluate complex scientific information and to make sound decisions.
- Line management experience.
- Expert knowledge of current animal health welfare and topical veterinary issues.
You must also have experience in or awareness of, or a demonstrable ability to get up to speed rapidly:
- The development and/or manufacturing, quality assessment or quality assurance of products such as cell therapies, monoclonal antibodies, nucleic acid vaccines, bacteriophage or other novel therapies.
IT Skills
- You must be proficient in the use of Microsoft Office packages, particularly Word, Excel and Outlook. You must use the internet effectively and have the aptitude to learn how to use the VMD's bespoke IT systems.
Qualifications
Behaviours
We'll assess you against these behaviours during the selection process:
- Leadership
- Making Effective Decisions
- Communicating and Influencing
- Developing Self and Others
Benefits
- Learning and development tailored to your role
- An environment with flexible working options
- A culture encouraging inclusion and diversity
- A Civil Service pension with an average employer contribution of 27%
- Free onsite parking
- Free eyesight test
- Onsite gym
- Access to a prayer room
Things you need to know
Selection process details
Application Process
As part of the application process, you will be asked to complete a CV and Personal Statement, and Behaviour Statements. Further details around what this will entail are listed on the application form.
The CV will ask for your job history, qualifications and past skills and experience.
Your Personal Statement should be no more than 750 words and should demonstrate how your qualifications / knowledge / skills / experience match the requirements set out in the job advert.
When giving examples of Behaviours please use the Situation, Task, Action, Result (STAR) format. Behaviours , Civil Service Careers (civil-service-careers.gov.uk)
Sift
Should a large number of applications be received, an initial sift may be conducted using the lead behaviour, Leadership
Candidates who pass the initial sift may be progressed to a full sift, or progressed straight to assessment/interview.
Interview
If successful at application stage, you will be invited to interview where you will be assessed on Behaviours and Experience.
A presentation or additional exercise may also be assessed. Successful applicants will be notified prior to interview.
Your interview will either be conducted face to face or by video. You will be notified of the location if you are selected for interview.
Sift and Interview dates
The sift will be conducted week commencing 7 October 2024.
Interviews are currently scheduled to take place in person at the VMD week commencing 28 October 2024.
Please note that this timeline is indicative at this stage and could be subject to change.
Reserve List
A reserve list may be held for a period of 12 months from which further appointments can be made.
Near miss
Whilst the jobs are advertised at G6 level suitable applicants that might not have the experience necessary for these roles might be considered for G7 Biologicals Assessor role.
Salary
New entrants are expected to start on the minimum of the pay band.
Location
As part of the pre-employment process for this post, successful candidate(s) will be able to agree a contractual workplace from those locations listed in this advert. The agreed contractual workplace is then the substantive and permanent place of work for the successful candidate(s)
Where the location is ‘National’ the successful appointee should discuss and agree an appropriate contractual location in line with both Defra’s location policy and site capacity, prior to proceeding with pre-employment processes.
Successful applicants currently employed by the hiring Defra organisation for this post may choose to remain in their current contractual location or may choose to change contractual location to one of those listed above. This should be discussed and agreed prior to proceeding with pre-employment processes.
The agreed amount of time spent at a workplace for this post will reflect the requirement for Civil Servants to spend at least 60% of their working time in an organisation workplace with the option to work the remaining time flexibly from home. Working time spent at a workplace may include time spent at other organisational locations including field-based operational locations, together with supplier, customer or partner locations. This is a non-contractual agreement which is consistent with common Civil Service expectations.
Travel costs to non-contractual workplaces will be subject to departmental travel and subsistence policies. Travel costs to contractual workplaces are the responsibility of the employee.
The successful candidate is required to carry out all their duties from a UK location, and cannot do so from an overseas location at any time.
Defra includes the core department, APHA, RPA, Cefas and VMD.
Please be aware that this role(s) will be contractually based at the VMD headquarters in Addlestone, Surrey. Fixed location, but flexible working arrangements.
Working Pattern
This is a full-time post. Job shares could be possible, although a degree of flexibility would be required so that the job holder(s) could take full responsibility for all aspects of their own work, including attendance at relevant meetings. In order for a job share to be considered there must be two people who are successful at interview who want to work in this way. Term time working would not be possible due to the short timelines assigned to the tasks and projects deadlines. This cannot be offered as an apprentice at this level due to the vast experience required for the role.
Visa Sponsorship Statement
Please take note that Defra does not hold a UK Visa & Immigration (UKVI) Skilled Worker License sponsor and are unable to sponsor any individuals for Skilled Worker Sponsorship
Passport
You must have a valid passport.
There is a possibility of overseas travel, Therefore the successful candidate should be prepared to travel overseas if necessary.
Reasonable Adjustment
If a person with disabilities is put at a substantial disadvantage compared to a non-disabled person, we have a duty to make reasonable changes to our processes.
If you need a change to be made so that you can make your application, you should:
- Contact Government Recruitment Service via defrarecruitment.grs@cabinetoffice.gov.uk as soon as possible before the closing date to discuss your needs.
- Complete the “Assistance required” section in the “Additional requirements” page of your application form to tell us what changes or help you might need further on in the recruitment process. For instance, you may need wheelchair access at interview, or if you’re deaf, a Language Service Professional.
Accessibility
If you are experiencing accessibility problems with any attachments on this advert, please contact the email address in the 'Contact point for applicants' section.
Criminal Record Check
If successful and transferring from another Government Department, a criminal record check may be carried out.
In order to process applications without delay, we will be sending a Criminal Record Check to Disclosure and Barring Service on your behalf. However, we recognise in exceptional circumstances some candidates will want to send their completed forms direct. If you will be doing this, please advise Government Recruitment Service of your intention by emailing Pre-EmploymentChecks.grs@cabinetoffice.gov.uk stating the job reference number in the subject heading.
Internal Fraud Database Check
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.
Higher Security Clearance
Please be aware the levels of national security clearance are changing which may impact on the level needed for this role by the time of appointment. All efforts will be made to keep candidates informed of any changes and what that will mean in terms of vetting criteria. For more information please See our vetting charter.
NSV
For further information on National Security Vetting please visit the following page https://www.gov.uk/government/publications/demystifying-vetting
Childcare Vouchers
Any move to Defra from another employer will mean you can no longer access childcare vouchers. You may however be eligible for other government schemes, including Tax Free Childcare. Determine your eligibility at https://www.childcarechoices.gov.uk
Feedback will only be provided if you attend an interview or assessment.
Security
Nationality requirements
Working for the Civil Service
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).
Diversity and Inclusion
Apply and further information
Contact point for applicants
Job contact :
- Name : Rory Cooney
- Email : r.cooney@vmd.gov.uk
Recruitment team
- Email : DefraRecruitment.grs@cabinetoffice.gov.uk
Further information
Government Recruitment Services via email: defrarecruitment.grs@cabinetoffice.gov.uk
If you are not satisfied with the response you receive from the Department, you can contact the Civil Service Commission: Click https://civilservicecommission.independent.gov.uk/contact-us/ to visit Civil Service Commission.
