Director - Fertility Laboratory
Stanford Medicine Children's Health · Sunnyvale, California, United States
At Lucile Packard Children’s Hospital Stanford, we know world-renowned care begins with world-class caring. That's why we combine advanced technologies and breakthrough discoveries with family-centered care. It's why we provide our caregivers with continuing education and state-of-the-art facilities, like the newly remodeled Lucile Packard Children's Hospital Stanford. And it's why we need caring, committed people on our team - like you. Join us on our mission to heal humanity, one child and family at a time.
Job ID: P147274-3442
JOB SUMMARY
This paragraph summarizes the general nature, level and purpose of the job.
Reporting to the Vice President of Ambulatory Services, the Director - Fertility Laboratory provides strategic, scientific, technical, operational, and quality leadership for the assisted reproductive technology (ART)/embryology, endocrinology, and andrology laboratory functions within the assigned Stanford Medicine Children's Health (SMCH) Reproductive Endocrinology and Infertility (REI) program. In close 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; prudent financial stewardship; and quality 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 the clinical, teaching, and research mission of Stanford Medicine. The Director shall perform legally designated laboratory director functions for applicable clinical laboratory testing and treatment only when individually qualified, licensed, and designated under California and federal requirements; institutional assignment of this title alone does not confer statutory director authority.
Key areas of responsibility 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.
ESSENTIAL FUNCTIONS
The essential functions listed are typical examples of work performed by positions in this job classification. They are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Employees may also perform other duties as assigned.
Employees must abide by all Joint Commission requirements, including but not limited to sensitivity to cultural diversity, patient care, patient rights and ethical treatment, safety and security of physical environments, emergency management, teamwork, respect for others, participation in ongoing education and training, communication, adherence to safety and quality programs, sustaining compliance with National Patient Safety Goals, and applicable licensure and health screenings.
Must perform all duties and responsibilities in accordance with the hospital's policies and procedures, including its Service Standards and Code of Conduct.
Strategic and Scientific Leadership
• 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, patient care pathways, new technologies, complex fertility treatment, third-party reproduction, fertility preservation and preimplantation genetic testing (PGT) workflows when offered.
• Establish, review and approve scientifically sound standard operating procedures, validation and verification plans, performance thresholds and change controls appropriate to the Director’s regulatory authority; ensure methods are clinically relevant and laboratory results are reliable and timely.
• Provide laboratory consultation to REI clinicians, nursing teams and other stakeholders; foster respectful interprofessional decision-making and transparent communication.
Laboratory Operations, Quality and Patient Safety
• Direct and evaluate daily embryology, endocrinology, and andrology laboratory operations, including appropriate laboratory support for IVF/ART procedures, gamete and embryo assessment, culture, micromanipulation, cryopreservation and warming, specimen preparation/testing, endocrine testing, and coordination with external reference laboratories, as applicable.
• Maintain validated witnessing, patient/specimen identification, labeling, chain-of-custody, traceability, storage monitoring and disaster-recovery processes for gametes, embryos and reproductive specimens.
• Own an integrated quality management system encompassing quality control, quality assurance, equipment and environmental monitoring, competency assessments, proficiency testing or approved alternatives where applicable, occurrence reporting, root-cause analysis, corrective/preventive actions and periodic management review.
• Establish dashboards and review performance indicators (e.g., identification/witnessing compliance, incident trends, turnaround times, fertilization, embryo development, cryosurvival, environmental excursions and laboratory contributions to ART outcomes), adjusting for case mix and clinical context.
• Oversee documentation, data integrity, electronic records, consent-related workflow controls, confidentiality, laboratory inventory, specimen disposition, and secure retention consistent with law and SMCH policy.
• Ensure safe physical 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.
Regulatory Compliance and Accreditation
• Ensure assigned clinical laboratory activities operate in conformity with applicable California Department of Public Health (CDPH) Laboratory Field Services requirements, federal CLIA and FDA provisions for covered testing, applicable accreditation standards, and institutional policies; document distinct regulatory scope for ART activities and diagnostic clinical laboratory testing.
• Maintain the appropriate active California director-level credential and federal CLIA laboratory-director qualifications when personally serving as the designated director; verify licensure, scope of practice and supervision requirements for all personnel performing regulated work.
• 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 for the program, 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 federal CLIA and FDA standards.
People Leadership and Organizational Culture
• Recruit, develop, supervise and evaluate embryologists, andrology and endocrine personnel and designated laboratory managers/supervisors; maintain role descriptions, staffing coverage plans, documented training. , competency and continued education.
• Assign laboratory duties only to appropriately credentialed and qualified personnel, with supervision and escalation consistent with California law, CLIA and institutional policy.
• Develop a culture of psychol