Predicine is a Silicon Valley-based global precision medicine company that is committed to developing the first- and best-in-class liquid biopsy cancer diagnostics and precision medicine portfolio to address the unmet medical needs in global drug development. We have developed an innovative liquid biopsy technology that is empowering biopharma partners in clinical drug development and oncology medicine research. Our international business services provide molecular insights to the top 10 MNC BioPharma’s to support biomarker-driven clinical trials in US, EU, APAC including China. We believe our most important asset is our people and are dedicated to maintaining a thriving workplace. We value a culture of Integrity, Innovation, Quality, Respect, Courage, Collaboration, Caring, and Communication.
We invite people who share the same values to join us !What You Will Do:As a Laboratory Director, you will oversee all aspects of laboratory operations to ensure the highest standards of quality, accuracy, and regulatory compliance. You must be
licensed In California, Texas and New York.
Your responsibilities will include:Leadership & Oversight:
- Establish and maintain policies and procedures for monitoring laboratory staff across all testing phases: pre-analytical, analytical, and post-analytical.
- Ensure all testing personnel have the appropriate education, experience, and documented training for the complexity of services provided.
- Supervise staffing to ensure a sufficient number of qualified personnel for testing, supervision, and consultation.
Quality & Compliance:
- Verify that all testing methods are performed accurately and reliably according to established procedures.
- Ensure that laboratory test systems provide consistent quality across the entire testing workflow.
- Confirm that an up-to-date procedure manual is available and followed by all staff.
- Ensure test result reports include all necessary information for clinical interpretation.
- Oversee the accuracy and precision of test methods through effective validation and verification procedures.
- Guarantee that selected test methods produce reliable, high-quality results.
Operational Standards:
- Maintain appropriate physical and environmental lab conditions to ensure safety and compliance with all regulations.
- Be accessible for on-site, phone, or electronic consultation when needed.
- May oversee up to five laboratory sites.
Personnel Management:
- Maintain written documentation of responsibilities for each lab employee, including:
- Authorized testing activities
- Required levels of supervision
- When director or consultant review is needed prior to reporting results
- Ensure general supervisors provide on-site oversight of staff performing high-complexity testing.
Proficiency Testing & Quality Assurance:
- Ensure participation in approved proficiency testing (PT) programs and that PT samples are handled identically to patient samples.
- Prohibit specimen referral and improper sharing of PT results.
- Ensure timely submission of PT results, appropriate review by staff, and corrective actions when needed.
- Maintain robust quality control (QC) and quality assessment (QA) programs to identify and address performance issues.
- Confirm that only accurate and reliable test results are reported and that corrective actions are taken when systems deviate from standards.
Qualifications (Must meet one of the following):
- MD, DO, or DPM licensed, and:
- Board-certified in anatomic or clinical pathology OR
- At least 1 year of experience directing or supervising non-waived testing OR
- Earned 20 CME credits in laboratory director duties since 09/01/1993 OR
- Equivalent training completed during medical residency
- Doctoral degree in laboratory science, and:
- Certified by an HHS-approved board OR
- At least 1 year of experience directing or supervising non-waived testing
- Master’s degree in lab science, plus:
- 1 year of lab training/experience AND
- 1 year of supervisory experience in non-waived testing
- Bachelor’s degree in lab science, plus:
- 2 years of lab training/experience AND
- 2 years of supervisory experience in non-waived testing
Additional Information:
- Travel may be required 30% to 50% of the time.
Our Opportunity
Predicine is a global molecular insights company that is committed to advancing precision medicine in oncology. Predicine has developed a breakthrough cell-free DNA- and cell-free RNA-based liquid biopsy technology enabling minimally invasive molecular diagnosis for treatment selection, therapy monitoring, and minimal residual disease and early cancer detection. The company has launched a portfolio of blood-, urine- and tissue-based diagnostic assays for oncology.What We Offer:
Competitive Benefits Package
We offer a comprehensive benefits program designed to support the well-being of our employees and their families. Eligible employees receive medical, dental, and vision coverage for themselves and their dependents. Additional benefits include stock options, 401(k) retirement savings with company match, and a fully paid one-month sabbatical after five years of continuous service.We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives.
Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation,
