Lab Director

• Evaluates, develops, implements and validates new analytical methodologies to provide coordinated solutions and clinical trial expertise to clients. Partners with third-party laboratories for tests not performed in-house. • Serves as the main point of contact between the laboratory, sponsors, and clinical investigators. Assists sponsors in developing protocols and joins investigator meetings as a scientific expert. • Performs financial analyses to improve cost efficiency of laboratory operations. Manages and controls budgets for cost expense reduction. Provides business updates to senior leadership. • Coordinates the prioritisation of space, capital equipment, and scientific instrumentation. • Identifies staffing needs to ensure the laboratory is staffed with qualified personnel. Manages laboratory performance and ensures accurate training. • Defines, implements and monitors standards of performance in quality control and quality assurance. Ensures consistent harmonization of assays across laboratories.

• Broad knowledge of bioanalytical laboratory operations for pharmaceutical and biotech industries • In-depth knowledge of large molecule bioanalytical, clinical laboratory science, GMP, FDA regulations concerning clinical labs processes in drug development process, method development, method validation, R&D, sample production and data processing • Excellent communication/interpersonal skills including presentation skills • In-depth knowledge of budgeting, forecasting and fiscal management • Demonstrated skills in planning and coordinating • In-depth global and cultural awareness • Strong organizational agility and demonstrated drive for results • Excellent coaching and mentoring skills • Excellent marketing and negotiation skills

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职位要求