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:
1. Lead, manage and supervise the team of assessors involved in the assessment of safety, efficacy and overall benefit risk of biological VMPs.
2. Work with the Head of Biologicals to coordinate the allocation of work and resources to ensure business targets are met efficiently.
3. Contribute to the formulation of national and international regulatory policies and guidelines for biological/immunological VMPs including novel therapy VMPs.
4. Support the implementation of the Veterinary Medicines Regulations (2013, as amended) and delivery of VMD�s Regulatory Science Strategy (2021-2026).
5. 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:
6. 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.
7. Present these reports to VMD�s formal committee charged with recommending approval or rejection of applications.
8. 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.
9. Provide expert scientific, technical and regulatory support to assessors.
10. Develop and update assessment procedures and guidelines.
�External engagement:
11. Provide and coordinate team scientific and regulatory advice and guidance to applicants and stakeholders.
12. Represent the organisation at national and international strategic meetings, committees and conferences.
13. Liaise with National and EU industry representative bodies.
14. 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.
15. Support VMD�s initiatives for global cooperation, work-sharing across regulatory jurisdictions, and capacity strengthening.
�Internal engagement:
16. Work collaboratively with other VMD teams for effective regulatory oversight specifically the Pharmaceuticals, Pharmacovigilance, Inspection and Legislation Teams.
17. 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:
18. Cultivate leadership skills, specialisms and awareness of scientific and regulatory developments within the team.
19. Plan for and identify assessor�s future skills and training needs, including novel therapies and technologies.
20. 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:
21. 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.
22. An understanding of the EU authorisation processes of biological/immunological VMPs as it applies to Northern Ireland.
23. 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.
24. Experience in evaluating preclinical and clinical data, conducting risk assessments and interpreting scientific literature.
25. 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.
26. Effective communication skills, both written and verbal, with the ability to convey technical information to diverse audiences.
27. Excellent analytical skills with the ability to critically evaluate complex scientific information and to make sound decisions.
28. Line management experience. �
29. 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:
30. 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
31. 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
A degree in veterinary medicine or in a relevant scientific life science discipline that is directly relevant to the assessment work of the Biologicals Team with relevant postgraduate experience or PhD equivalent.
Behaviours
We'll assess you against these behaviours during the selection process:
32. Leadership
33. Making Effective Decisions
34. Communicating and Influencing
35. Developing Self and Others
Benefits
Alongside your salary of �67,640, Veterinary Medicines Directorate contributes �19,595 towards you being a member of the Civil Service Defined Benefit Pension scheme.
36. Learning and development tailored to your role
37. An environment with flexible working options
38. A culture encouraging inclusion and diversity
39. A with an average employer contribution of 27%
40. �Free onsite parking
41. Free eyesight test
42. Onsite gym
43. Access to a prayer room