Full-Time Laboratory & Medical Director

Position Summary: As the Laboratory and Medical Director, the employee is responsible for clinical leadership of laboratory services and products. Oversees all lab operations (patient care, clinical trials, research) ensuring compliance with regulations. Key to developing, validating, and operating Guardant's products in various locations and regulatory environments.

Essential Duties & Responsibilities:

1. Acts as temporary Laboratory Director in absence.
2. Delegates responsibilities to qualified employees (Technical Supervisor, General Supervisor, Clinical Consultant, Testing Personnel).
3. Ensures proper performance of all Clinical Laboratory duties.
4. Provides onsite, telephone, or electronic consultation as needed.
5. Ensures quality laboratory services (pre-analytic, analytic, post-analytic phases).
6. Maintains safe lab environment, addresses physical/environmental conditions.
7. Ensures test methodologies provide required quality results for patient care.
8. Confirms verification procedures for accuracy/precision of methods.
9. Ensures personnel perform tests for accurate results.
10. Laboratory participates in proficiency testing, reviewing results, taking corrective action for any issues.
11. Establishes and maintains quality control/quality assessment programs.
12. Maintains analytical performance for each test system.
13. Takes remedial actions for significant deviations in performance and ensures proper reporting of results.
14. Ensures reports include necessary interpretation information.
15. Provides consultation to clients on test quality/interpretation.
16. Supervises high-complexity testing with a General Supervisor.
17. Ensures sufficient staff with appropriate education/experience for accurate testing and reporting.
18. Ensures personnel have proper education, training, and demonstrated competence for reliable testing.
19. Establishes policies/procedures for monitoring pre-analytic, analytic, and post-analytic phases of testing.
20. Ensures availability of an approved procedure manual to all personnel.
21. Clearly defines responsibilities and duties of consultants, supervisors, and testing personnel, specifying authorized procedures and required supervision.
22. Reviews Standard Operating Procedures biennially.
23. Reports test quality/safety concerns to the Laboratory Supervisor or Safety Officer.

Qualifications:

• MD or DO licensed in California.
• Board certified in Anatomic or Clinical Pathology, or equivalent qualifications.
• 1 year of lab training during medical residency (e.g., Hematology/Hematology & Medical Oncology certification).
• 2 years of experience directing or supervising high complexity testing.
• Doctoral degree in a relevant lab science, board certified by HHS-approved board.
• Before 2/24/2003, served as lab director for high complexity testing with 2 years lab experience/training or 2 years of laboratory experience directing or supervising high complexity testing, or both.
• Qualified under State law to direct a lab (before 2/28/1992).
• Fulfills requirements of 42 CFR 493.1443

Work Environment: Flexible hours, potential for standing/sitting, exposure to hazardous materials, blood specimens, instruments, and lab environments.

Salary Range: $235,600 - $318,100 (USD) - Full-time, excludes benefits, potential bonuses.

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