Laboratory Medical Director
Biofidelity
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Posted 6+ months ago
Biofidelity is a revolutionary genomic technology company dedicated to unleashing the potential of genomics to transform human health and the world we live in. Our adaptive platform technology removes the noise from genomic data, providing only the information needed to make decision making less complex, faster, and more accurate.
At Biofidelity we are proud to have built a culture of humanity, openness and high expectations. We work towards well-defined goals, with a strong belief that we can make genomics globally accessible. Our people are keen to take responsibility for their work and share both their successes and challenges.
The role
Biofidelity is seeking an experienced Laboratory Medical Director to direct and supervise CLIA/CAP laboratory testing and performance while ensuring all aspects of relevant regulatory and accreditation requirements are met. The ideal candidate has excellent leadership and communication skills, is collaborative and finds solutions with an empathetic approach that gets results. This role reports to the Chief Operating Officer.
Key responsibilities:
● Provide laboratory director oversight of the CLIA/CAP laboratory testing operation in conjunction with the Director of Operations (CLIA/CAP) to ensure regulatory and licensing standards are met
● Work with the COO and Director of Operations (CLIA/CAP) to develop and implement laboratory testing systems that provide high quality and performance, across pre-analytic, analytic and post-analytical phases of testing
● Ensure that the laboratory, and tests, are compliant with applicable regulatory standards
● Review, release and effectively communicate laboratory data and patient results to authorized recipients
● Participate in clinical report review including assay interpretation and report sign-out within the required turnaround time
● Work closely with Director of Operations (CLIA/CAP) to continuously improve laboratory operations, including reviewing training and standard operating procedures
● Assist with verification and validation of new tests, instruments and methods prior to their use in patient tests in line with appropriate regulatory requirements
● Ensure that analytical performance is maintained by monitoring test performance, engaging in proficiency testing schemes, and investigating and remedying any deviation from established performance specifications
● Consult with the IT team to implement tools, including CRM and LIMs, used for patient testing
● Visit the lab as needed
Knowledge, Skills, And Abilities:
● In depth knowledge of CAP and CLIA regulations
● Knowledge of California and New York State regulations (desired)
● Strong influencing, communication and interpersonal skills
● Experience with clinical qPCR, NGS or other clinical laboratory testing in
oncology testing
● Possesses a flexible mindset and ability to successfully navigate in a small,
fast-growing company
Requisite Education and Experience / Minimum Qualifications:
● (MD or DO) Current NC medical license and board-certification in Anatomic and/or Clinical Pathology. Board certification or board eligibility in Molecular Genetic Pathology (MGP) is also desirable. (PhD only) Doctoral degree in chemical, physical, biological, or clinical laboratory sciences from an accredited institution and fellowship training in Clinical Molecular Genetics with ABMG or ABB certification and ability to act as high complexity laboratory director
● 5 or more years of experience as a Clinical Laboratory Director in a high-complexity setting
The consultant will be paid an estimated rate of $100-250/hour (20 hours/week). The actual rate will vary based on factors including qualifications, experience and location. At Biofidelity, we take a market-based approach to compensation to ensure we are objective, equitable and competitive.
This job is no longer accepting applications
See open jobs at Biofidelity.See open jobs similar to "Laboratory Medical Director" Octopus Ventures.