Study Director

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Job Introduction

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:

• 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