Biofidelity’s mission is to improve and extend the lives of patients with cancer 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 humanity, openness and high expectations. 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.

Alongside a competitive salary and opportunities for career development, we offer a comprehensive benefits package including medical, dental and vision coverage, 401(k), bonus, stock options, 20 days per year PTO allowance and 2 floating holidays in addition to Company observed holidays.

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:
?      Ensures that the laboratory, and tests, are compliant with applicable regulatory standards
?      Ensures that tests provide high quality and performance, across pre-analytic, analytic and post-analytical phases of testing
?      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 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: 
?      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
 
Biofidelity prefers our employees to be vaccinated for COVID but we are not requiring COVID vaccinations at this time. We are requiring twice weekly antigen testing for any employees that visit or work on-site.