Laboratory Medical Director
Biofidelity’s mission is to improve and extend cancer patients’ lives by enabling better targeting of therapies, early detection of treatment resistance, and routine monitoring of treatment response. Our unique technology is designed to allow rapid, broad adoption of our assays in testing labs around the world, enabling a step change in patient care.
At Biofidelity we are proud to have built a culture of teamwork, openness and trust. We work towards well-defined goals, with a strong belief that we can bring real benefits to patients. Our people are keen to take responsibility for their work and share both their successes and challenges.
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.
Develops and implements laboratory testing systems that provide high quality and performance, across pre-analytic, analytic and post-analytical phases of testing
Ensures that the laboratory, and tests, are compliant with applicable regulatory standards
Reviews, releases and effectively communicates laboratory data and patient results to authorized recipients
Works closely with Director of Operations (CLIA/CAP) to continuously improve laboratory operations, including reviewing training and standard operating procedures
Assists with verification and validation of new tests, instruments and methods prior to their use in patient tests in line with appropriate regulatory requirements
Ensures that analytical performance is maintained by monitoring test performance, engaging in proficiency testing schemes, and investigating and remedying any deviation from established performance specifications
Interacts with the IT team to implement tools, including CRM and LIMs, used for patient testing
Regularly communicates with the R&D team to provide insights for new test development
Fosters openness, trust and accountability
Knowledge, Skills and Abilities:
In depth knowledge of CAP, CLIA, California and New York state regulations
Strong influencing, communication and interpersonal skills
Experience with clinical qPCR, NGS or other clinical laboratory testing in molecular pathology areas
Possesses a flexible mindset and ability to successfully navigate in a small, fast-growing company
Requisite Education and Experience / Minimum Qualifications:
PhD in a biological science or MD in Pathology (preferred)
ABMGG, ABP, ABB in molecular diagnostics, or equivalent laboratory director certification in Clinical Molecular Genetics/Pathology
5 or more years of experience as a Clinical Laboratory Director in a high-complexity setting
To apply, please email your CV and cover letter to email@example.com.
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