This commercial Clinical Diagnostics company is developing and performing new assays to guide treatment of chronic kidney disease (CKD) and inform medical decision making in kidney transplant. Chronic kidney disease afflicts roughly 30 million American adults with over 90% of individuals who have CKD unaware that they have it. There are currently few treatments beyond alleviating symptoms. The company and therefore the laboratory operations will rapidly expand in scope and scale in 2020 and will continue its mission of developing novel assays and tools to advance patient care and outcomes. The company pairs laboratory science with artificial intelligence to create innovative solutions.
We are looking to fill the senior position of Head of Clinical Laboratory Operations who, in addition to providing leadership across all clinical laboratory operations, would also own responsibility for strategic customer engagement, cross functional program management, and organizational development. We seek an individual with experience in a NYSDOH, CLIA, CAP and FDA regulatory environments, a passion for developing new diagnostic tests and an un-wavering focus on customer satisfaction.
Team: Report to the Chief Executive Officer. Establish, validate and scale multiple new laboratory facilities. Oversee a team of clinical laboratory scientists, and technical supervisors, a team which will expand in future growth to include various clinical, IT, and research personnel. Engage executive, administrative, commercial, clinical and research & development groups in leading and supporting key strategic objectives of the company.
Duties and Responsibilities:
· Responsible for Technology transfer and validation of novel clinical diagnostics assays into commercial operations
· Direct the laboratory quality assurance program that is appropriately designed and maintained in accordance with governing regulations including NYSDOH/CLIA/CAP/FDA
· Work with team to prepare for and maintain successful accreditation to NYSDOH/CLIA/CAP/FDA
· Ensure inspection-readiness for regulatory or partner audits
· Work with the Laboratory Medical Director to identify and monitor Laboratory Key Performance Indicators (KPIs) to effectively drive continuous process improvement program
· Partner with Product Development teams in planning and execution of novel assays development and validation
· Work closely with commercial operations to builds relationships with internal and external customers and collaborators
· Responsible for integration of company laboratory operations with third party stakeholders, including direct customers, integrated health systems and payors
· Develop and implement a strategic project management framework
· Oversee capital planning and procurement
· Ensure proper maintenance, safety practices and training on equipment are occurring as intended
· Liaise with Facilities Management on laboratory needs and facility improvements
· Responsible for budgeting for laboratory operations
· Manage medical laboratory staff by recruiting, selecting, training and developing employees
Requirements and Education
Requirements and Education: Bachelor’s degree and minimum of ten years of experience. Master’s degree in Laboratory Medicine or related field is preferred.
Must hold a current or be immediately eligible to apply for a New York State Clinical Laboratory Scientist license.
Experience Displayed clinical / research + administration experience working in a CLIA regulatory environment, experience in forward-facing activities during laboratory inspections is a plus. Demonstration of people leadership skills with an ability to be an ambassador for corporate relations. Experience in novel molecular diagnostics assay development and commercial translation is highly desired
· Success in organizational development and relationship building
· Proven track record of laboratory leadership
· Demonstrated competency in managing multi-disciplinary projects
· Competitive salary and full benefits package.
· Opportunity to develop, validate and perform diagnostics that are cutting-edge
· Chance to develop novel tools and tests that impact millions.
· Opportunity to advance career within a high-growth organization