We are looking for: Study Director join our Metabolism department and use their expertise in Animal Technology to manage and conduct the in life phase of a range of PK and PD studies, for new product development, based on global regulatory requirements. The position is based at a facility in Loughborough, UK. At Pharmaron we offer:
1. Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
2. Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
3. A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Key roles and responsibilities:
4. Conduct ASPA licensed procedures (e.g. dose administration, blood sampling) on a range of species
5. Act as a Study Director on PK studies
6. Take full responsibility for the conduct of experimental work to successfully fulfil all the requirements of studies to the timelines in the study plan
7. Responsible for the formulation of test materials
8. Prepare study plans, amendments, file notes and deviations, as required
9. Prepare study reports
10. Responsible for technical training (writing and review of training materials) and maintenance of laboratory work standards in their area.
11. Mentor new Technical Specialists and other senior laboratory staff.
12. Provide technical advice to Study Directors/Management at all points in the study life cycle.
13. Lead process improvement/new service development projects in their specialist area
14. Hold equipment/software/ lab space responsibilities on behalf of their team.
15. Increase profile of the department externally by publishing papers/posters and participation in expert groups.
16. Work with Team Leader on client communication, contributing scientifically to client discussions, as appropriate.
17. Interpret the relevant data and prepare accurate scientific study updates and contribute to reports.
18. Address findings appropriate to area arising from QA audits and process inspections.
19. Maintain and write SOPs, as required.
20. Lead implementation of continuous improvement culture in specialist area proposing process improvement/new service offering initiatives to the Metabolism leadership team.
21. Keep up to date with technical developments in specialist area recommending new techniques and working with management to compile justification for Capex projects.
Requirements:
22. Home Office Personal License holder (PIL) for many years
23. Experience of study directing PK studies in a GLP facility
24. Experience of formulating test materials
25. Experience of working with Immunocompromised animals
26. Highly proficient in performing a range of ASPA licensed procedures (e.g. dose administration and blood sampling)
27. Surgical skills
28. Coaching & Mentoring
29. Project Management
30. Scientific data interpretation, reporting and presentation skills
31. Effective written and verbal communication skills, including the ability to effectively present scientific findings to colleagues and clients
32. Organisational skills
33. Problem solving
34. Prioritising and scheduling
35. Good knowledge of Microsoft Office software