22p-124- Clinical Lead
2 weeks ago
**Organisation position and purpose**
The Veterinary Vaccine Manufacturing and Innovation Centre (Vet-VMIC) at The Pirbright Institute has been recently established to help meet an unmet global need for livestock vaccines with a focus on priority diseases for Low
**Main duties and responsibility**
- and Middle-Income Countries, aligned with the Vet-VMIC strategy. This will involve the selection of the relevant animal model that best exemplifies the platform in question and overseeing the clinical studies from initial design to a GCP standard, through to characterisation of clinical samples. The applicant will be expected to work with partners to establish the best methods for demonstrating effectiveness of the vaccine in the field in support of regulatory filings.
**This includes**:
- The design, conduct and reporting of clinical trials in order to assess the safety and efficacy of experimental vaccines.
- The conduct of safety and efficacy regulatory studies to a GLP and GCP standard for vaccine registration.
- The conduct of GCP clinical field trials to determine the safety and efficacy of vaccines for licencing.
- To incorporate Good Clinical Practice GCP to a compatible standard to that used during the development of commercial vaccines by major manufacturers.
- To support other R&D activities and workstreams conducted within Vet-VMIC.
- To engage and work effectively with the clinical team across the Pirbright site more broadly.
- To participate in training necessary for Vet-VMIC R&D activities.
This job description is only an outline of the tasks, responsibilities and outcomes required of the role. The jobholder will carry out any other duties as may be reasonably required by his/her line manager. The job description and personal specification may be reviewed on an ongoing basis in accordance with the changing needs of The Pirbright Institute.
All employees shall actively participate in the Institute-wide quality assurance system in conjunction with the Institute’s Quality Manager. _Employees are also expected to safeguard their own health and safety and security by following policies and all e_mployees are responsible for the Health and Safety and security of staff under their management.
**Personal specification**
Time management, reliability under pressure, decision making/problem solving skills, action-oriented, entrepreneurial, creative, influential, collaborative, diplomatic, results driven, passionate, engaging and recognising.
**Specific requirements**
**Essential**
- A PhD or equivalent in a relevant branch of biosciences.
- Experience of working on clinical trials within livestock
- Experience in designing and supervising GCP clinical trials both under controlled laboratory conditions and in the field.
- Experience of writing GCP protocols and reports.
- Ability to work with Clinical Research Organizations (CROs) in the running of clinical trials for feasibility testing and commercial vaccine registration.
- Laboratory experience that encompasses a wide range of molecular biology techniques.
- Ability to work independently and as a member of a group.
- Ability to multitask with good planning skills.
- Excellent communication skills.
- Good networking skills with the ability to build effective collaborative relationships including with stakeholders.
- Experience of Working with pathogens and/or in high containment facilities.
**Desirable**
- Good networking and communication skills with the ability to build effective collaborative relationships including with stakeholders.
- Published work on clinical trials.
- Experience of working to Good Laboratory practices (GLP), and Good Manufacturing Practice (GMP)
- Personal Licence Holder within the UK
Due to the nature of the work we do, all successful applicants will be required to go through a comprehensive screening process including reference and qualification checks, financial and security clearances.
The Pirbright Institute may be able to make a financial contribution towards the cost of immigration to the UK.
**What we offer**
- 25 days annual leave per annum, pro rata, plus 10.5 public and privilege days
- Buy and sell annual leave
- Option to carry over up to two weeks annual leave
- Pirbright gym with subsidised membership
- Pirbright social club
- Pirbright Lifestyle Hub (employee discount site)
- Cycle to work
- Subsidised staff restaurant
- Childcare allowance
- Free onsite parking
- Electric Car charging facilities
The Institute is committed to retaining staff employed on fixed term contracts of employment. The Institute operates a Redeployment process which is the moving of an employee from one role to another suitable alternative role, when possible, to avoid compulsory redundancies.