A Pharmacokinetic/ BioAnalysis Project Manager is required for our client who specialises in providing solutions for life sciences in Biomarkers, Pharmacokinetics, Bioanalysis and Logistics. You will provide bioanalytical scientific oversight, budgetary and project management of outsourced Pharmacokinetic bioanalysis at contract research organisations on behalf of clients in clinical and pre-clinical development for human therapies.
Key Duties and Responsibilities:
Provide oversight and management of method establishment, fit-for-purpose assay validation and the measurement and reporting of sample analysis.
Provide expertise and knowledge in the application and operation of quantitative bioanalytical techniques, including mass spectrometric chromatographic and ligand binding assays for NCE, NBE and biosimilars.
Interact effectively with various client functional/stakeholder groups involved in sample analysis and data processing. These will include the client CRO facing sample managers, CRO laboratory based bioanalytical scientists, client and contracted pharmacokinetic and pharmacology experts, data acquisition function and sample repository representatives.
Provision of expert input in sourcing, selecting, and engaging appropriate CRO bioanalysis providers for clients
Upload and verify bioanalytical data generated by CROs.
Review of draft and final assay validation and bioanalytical sample analysis reports.
Key skillset / experience required:
Degree in a biological science with a further higher degree as desirable
Extensive knowledge of bioanalysis within regulatory environments (GLP and GCP).
Comprehensive knowledge in design and operational execution of clinical and pre-clinical studies, toxicokinetic and pharmacokinetic analysis.
Practical experience of managing and developing bioanalytical methods, assay validation and study data generation in clinical and pre-clinical studies.
Knowledge of the application and operation of a range of bioanalytical techniques, including mass spectrometric chromatographic and ligand binding assays.
Previous experience in managing contract research organisations