Director - Fertility Laboratory

Stanford Medicine Children's Health•Sunnyvale, CA

4d•$104 - $135•Onsite

About The Position

Reporting to the Vice President of Ambulatory Services, the Director - Fertility Laboratory provides strategic, scientific, technical, operational, and quality leadership for assisted reproductive technology (ART)/embryology, endocrinology, and andrology laboratory functions within the assigned Stanford Medicine Children's Health Reproductive Endocrinology and Infertility program. In partnership with the REI Medical Director, physicians, nursing, program operations, and institutional leaders, the Director is accountable for reliable laboratory operations; the safety, identity, integrity, and traceability of gametes and embryos; regulatory readiness and compliance; appropriate staffing and competency; financial stewardship; and continuous improvement of clinical and patient/family outcomes. The Director establishes and maintains evidence-based laboratory policies, supervises qualified personnel, provides clinical and scientific consultation, leads laboratory planning and innovation, and supports Stanford Medicine's clinical, teaching, and research mission. Legally designated laboratory director functions for applicable clinical laboratory testing and treatment may be performed only when the Director is individually qualified, licensed, and designated under California and federal requirements. The position's key areas include embryology/IVF, diagnostic and therapeutic andrology, endocrine testing, cryopreservation and cryorepository management, laboratory quality and safety, staff leadership, regulatory compliance, equipment and facility oversight, data integrity and reporting, financial management, and academic partnership. The position directs daily embryology, endocrinology, and andrology operations; maintains systems for specimen identification, witnessing, chain of custody, traceability, storage monitoring, and disaster recovery; and leads quality management, regulatory readiness, safety, and performance monitoring. It also recruits and develops laboratory staff, manages budgets and capital plans, supports technology and process improvements, and contributes to teaching, trainee supervision, presentations, case review, and collaborative research.

Requirements

Ph.D., Sc.D., or DCLS from an accredited institution in chemical, physical, biological, or medical laboratory science as the major subject, including at least 32 semester hours of undergraduate or graduate coursework in biology, chemistry, or medical laboratory science; an M.D. or D.O. from an accredited institution is also qualifying with matching laboratory criteria.
At least seven years of clinical laboratory training or experience on human specimens within the last 10 years.
At least seven years of direct experience managing, supervising, and directing high-complexity testing and laboratory staff; this experience may be concurrent with clinical laboratory experience.
Documented log of at least 60 human ART procedures, including follicular aspirate examination, insemination/ICSI, fertilization assessment, and embryo transfer preparation, completed under supervision and verified by a training Laboratory Director.
Document at least 24 hours of accredited continuing education in ART or clinical laboratory practice every two years.
Active certification as a High-Complexity Clinical Laboratory Director (HCLD) from the American Board of Bioanalysis (ABB).
Advanced embryology expertise, including human cell culture, micromanipulation (ICSI and assisted hatching), vitrification, and PGT biopsy protocols.
Deep familiarity with California laboratory law, tissue banking regulations, OSHA requirements, and CAP inspection checklists.
Proficiency in experimental design, statistics, data analytics, and troubleshooting embryonic culture systems.
Exceptional interpersonal and communication skills to consult with medical professionals, manage diverse team dynamics, represent the laboratory to patients, and handle sensitive confidential information discreetly.
Ability to meet applicable hospital, Joint Commission, safety, quality, education, communication, and patient-care requirements.

Nice To Haves

Current, valid Clinical Reproductive Biologist Director License issued by the California Department of Public Health, Laboratory Field Services; if not held at hire, it must be obtained within one year of hire.

Responsibilities

Lead strategic and annual operational planning for assigned REI laboratories in alignment with clinical demand, institutional goals, patient safety, and available resources.
Partner with the REI Medical Director and clinical leadership on laboratory practice, care pathways, new technologies, complex fertility treatment, third-party reproduction, fertility preservation, and PGT workflows when offered.
Establish, review, and approve scientifically sound standard operating procedures, validation and verification plans, performance thresholds, and change controls within the Director’s regulatory authority.
Provide laboratory consultation to clinicians, nursing teams, and other stakeholders, supporting interprofessional decision-making and transparent communication.
Direct and evaluate daily embryology, endocrinology, and andrology operations, including laboratory support for IVF/ART procedures, gamete and embryo assessment, culture, micromanipulation, cryopreservation and warming, specimen preparation and testing, endocrine testing, and coordination with external reference laboratories as applicable.
Maintain validated witnessing, patient and specimen identification, labeling, chain-of-custody, traceability, storage monitoring, and disaster-recovery processes for gametes, embryos, and reproductive specimens.
Lead an integrated quality management system covering quality control and assurance, equipment and environmental monitoring, competency assessments, proficiency testing or approved alternatives, occurrence reporting, root-cause analysis, corrective and preventive actions, and management review.
Establish and review performance dashboards and indicators, including identification and witnessing compliance, incident trends, turnaround times, fertilization, embryo development, cryosurvival, environmental excursions, and laboratory contributions to ART outcomes.
Oversee documentation, data integrity, electronic records, consent-related workflow controls, confidentiality, inventory, specimen disposition, and secure retention in accordance with law and institutional policy.
Ensure safe facilities and appropriate maintenance, calibration, qualification, and replacement planning for instruments, incubators, air-handling systems, cryostorage systems, and consumables.
Maintain emergency preparedness, after-hours coverage, and business continuity plans for equipment failure, power loss, cryogenic hazards, environmental incidents, and laboratory interruptions.
Ensure assigned clinical laboratory activities conform to applicable CDPH Laboratory Field Services requirements, federal CLIA and FDA provisions for covered testing, accreditation standards, and institutional policies; document the distinct regulatory scope of ART activities and diagnostic clinical laboratory testing.
Maintain appropriate active California director-level credentials and federal CLIA laboratory-director qualifications when serving as the designated director, and verify personnel licensing, scope of practice, and supervision requirements.
Lead internal audits, inspection readiness, onsite surveys, deficiency remediation, and regulatory communication in coordination with compliance and institutional leadership.
Ensure accurate and timely ART outcome and cycle data submissions to SART and/or CDC when required, with documented quality checks and responsible physician collaboration.
Oversee biosafety, infection prevention, occupational health, privacy, and laboratory risk-management programs within institutional accountability structures and applicable standards.
Recruit, develop, supervise, and evaluate embryologists, andrology and endocrine personnel, and designated laboratory managers or supervisors; maintain role descriptions, coverage plans, training, competency, and continuing education.
Assign laboratory duties only to appropriately credentialed and qualified personnel, with supervision and escalation consistent with California law, CLIA, and institutional policy.
Foster psychological safety, accountability, constructive error reporting, inclusion, mentorship, professional growth, and continuous improvement.
Provide training and scientific oversight for evolving procedures, and participate in hands-on laboratory work when needed and appropriately qualified without compromising leadership responsibilities.
Develop and manage laboratory budgets, staffing models, capital equipment plans, supply agreements, and expense controls; investigate variances and steward resources without compromising quality or safety.
Collaborate with Finance, Supply Chain, facilities, and information services on vendor qualification, contracting, service agreements, validated technology adoption, laboratory information systems, data management, and cybersecurity.
Lead process improvements to optimize service reliability, capacity, and operational efficiency; assess new methods through risk assessment, validation, clinical governance, and regulatory review.
Support the academic mission through teaching, authorized trainee supervision, scientific presentations, interdisciplinary case review, and collaborative research consistent with clinical obligations and approved protocols.
Establish collaborative relationships with Stanford School of Medicine, medical genetics, reproductive medicine, and other scientific partners; evaluate research-to-practice translation through institutional review and validation processes.
Perform duties in accordance with hospital policies and procedures, Service Standards, Code of Conduct, Joint Commission requirements, and applicable safety, quality, education, communication, and patient-care standards.