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I am currently working with a global leader in the Cell & Gene Therapy field. Over 5 programs across numerous therapeutics areas, with Clinical trials are ongoing in both phase 1/2 and 3 . They are now looking to grow by 25%. within their Bioanalysis department.
You will execute on the strategy to grow Bioanalysis (clinical assays) laboratory function with a remit to develop, validate and operate 'custom' assays for patient screening and/or monitoring.
Co-operate with the Clinical Translation, Medical and Research groups to understand future clinical testing needs and ensure expert input into clinical protocol design, including sampling plans for real time and long term and follow up assessments
Line management, development and appraisal of clinical testing team members
Accountable to ensure secure execution of ongoing patient screening and monitoring assays (in-house and with partners) to support recruitment into clinical studies and timely clinical study data provision
Ensure robust development of assays to meet new clinical requirements in compliance with best practice and relevant regulatory standards
Ensure clinical phase-appropriate validation of assays and data integrity.
Ensure smooth transfer of assays to CROs where needed with continuing technical and business oversight
Ensure appropriate selection and audit/oversight of specialist clinical laboratories and clinical research organizations and develop KPIs to monitor performance on an ongoing basis
Develop and maintain a business plan and operating budget covering staffing, revenue, facility/capital and partnering needs for both near and long-term needs
Transfer in and establish new technologies and assays as required
A higher degree in a Life Science or Clinical Science/Biochemistry
A professional qualification in Clinical Science/Laboratory Medicine
Minimum of 10 year's experience in pharmaceutical clinical development, or clinical testing in the healthcare industry
Substantial experience of developing and overseeing clinical testing operations in a regulated environment
Deep understanding of experience of bioanalytical method development, validation and technology transfer, external quality assessment schemes.
Deep understanding of regulatory and quality frameworks for in vitro diagnostic systems and experience of regulatory inspections and laboratory accreditation
Practical experience of analytical techniques such as qPCR, DNA Sequencing, Immunoassays, Electrophoresis, Cell Based Assays