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Job Introduction
We are looking for:
A Study Director to 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:
* 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!
* Opportunities to develop your skills and yourself - our rapid growth brings greater opportunities for you to learn and grow faster!
* 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:
* Conduct ASPA licensed procedures (e.g. dose administration, blood sampling) on a range of species.
* Act as a Study Director on PK studies.
* Take full responsibility for the conduct of experimental work to successfully fulfil all the requirements of studies to the timelines in the study plan.
* Responsible for the formulation of test materials.
* Prepare study plans, amendments, file notes and deviations, as required.
* Prepare study reports.
* Responsible for technical training (writing and review of training materials) and maintenance of laboratory work standards in their area.
* Mentor new Technical Specialists and other senior laboratory staff.
* Provide technical advice to Study Directors/Management at all points in the study life cycle.
* Lead process improvement/new service development projects in their specialist area.
* Hold equipment/software/lab space responsibilities on behalf of their team.
* Increase profile of the department externally by publishing papers/posters and participation in expert groups.
* Work with Team Leader on client communication, contributing scientifically to client discussions, as appropriate.
* Interpret the relevant data and prepare accurate scientific study updates and contribute to reports.
* Address findings appropriate to area arising from QA audits and process inspections.
* Maintain and write SOPs, as required.
* Lead implementation of continuous improvement culture in specialist area proposing process improvement/new service offering initiatives to the Metabolism leadership team.
* Keep up to date with technical developments in specialist area recommending new techniques and working with management to compile justification for Capex projects.
Requirements:
* Home Office Personal License holder (PIL) for many years.
* Experience of study directing PK studies in a GLP facility.
* Experience of formulating test materials.
* Experience of working with Immunocompromised animals.
* Highly proficient in performing a range of ASPA licensed procedures (e.g. dose administration and blood sampling).
* Surgical skills.
* Coaching & Mentoring.
* Project Management.
* Scientific data interpretation, reporting and presentation skills.
* Effective written and verbal communication skills, including the ability to effectively present scientific findings to colleagues and clients.
* Organisational skills.
* Problem solving.
* Prioritising and scheduling.
* Good knowledge of Microsoft Office software.
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