Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07249 About our client Our client is a development-stage pharmaceutical company focused on novel treatments for a variety of disorders. They boast a strong, late-stage pipeline, a fantastic management team and are dedicated to the professional success of their employees. This is an excellent opportunity for the right person. Position Location Director of Laboratory Services MD Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide expertise in regard to laboratory procedures, tests and methods in support of clinical protocol development with a focus on program and company-wide standards, best practices and efficiencies 2) Perform technical assessment, including literature searches and communicate impact of laboratory specifications on protocol feasibility and scope 3) Collaborate with the Research Department to make sourcing decisions regarding assay development and validation 4) Lead the identification of appropriate vendors and assess capabilities, capacity and compliance 5) Coordinate assay validation and transfer activities with vendors and collaborators 6) Lead the development of specifications, scope of work documents and training materials for outsourced work with a focus on best practices, standards and combinability of data across non-affiliated labs 7) Act as a primary interface with laboratory vendors to set expectations, provide appropriate sponsor supervision and monitor performance of operational activities 8) Support Clinical Trial teams throughout the conduct and delivery of clinical trial activities, assessing trends, managing risk, identifying issues and implementing corrective actions 9) Support CQA in audit planning, response and corrective action identification/implementation Requirements 1) Med. Tech., RN or BS in Biochemistry with appropriate level of directly applicable experience 2) Advanced degree in a relevant scientific discipline 3) At least 5 years of experience in lab management 4) 8+ years of experience in the pharmaceutical/biotech industry, CRO and/or lab vendor with a focus on laboratory medicine and diagnostic services in the context of clinical trials 5) Thorough understanding of laboratory procedures, tests and methods 6) Understanding of the operations of laboratory vendors and the certifications, regulations and guidance documents that govern them
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