Associate Lab Director, PO Medical

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Position Overview

The Associate Lab Director PO Medical is responsible for the technical and scientific oversight of all highcomplexity molecular testing in a highthroughput commercial clinical laboratory that supports U.S. and international clients. The role focuses on ensuring analytical excellence regulatory and accreditation compliance across multiple jurisdictions operational scalability and strong collaboration with internal and external stakeholders to deliver accurate and timely molecular test results at large volume.

Essential Duties

Include but are not limited to the following:

• Lead and support development of performance specifications for tests in partnership with Product and R&D teams ensuring robust documentation suitable for U.S. and international regulatory and client audits.
• Lead design validation verification and implementation of new molecular assays and panels including largescale highthroughput workflows and automation in accordance with CLIA highcomplexity requirements and applicable accreditation standards.
• Establish implement and oversee comprehensive quality control and quality assurance programs tailored to molecular testing (e.g. contamination control internal controls external controls bioinformatics quality metrics pipeline monitoring). Monitor and analyze key performance indicators (KPIs) for molecular operations (e.g. throughput TAT adherence by client/region failure/repeat rates contamination events QC failure trends sequencing quality metrics ontime reporting).
• Ensure compliance with regulatory accreditation requirements (e.g. CAP ISOaligned client expectations) for highcomplexity molecular testing and medical professional standards and best practices. Incorporate key regulatory expectations of major client markets outside the U.S. where contractually applicable.
• Collaborate closely with operations leadership to design and optimize scalable workflows including sample accessioning nucleic acid extraction library preparation amplification sequencing and data analysis to meet aggressive turnaroundtime commitments.
• Design and maintain structured initial and ongoing competency assessments for molecular staff including direct observation proficiency samples result interpretation exercises and bioinformatics QC review where appropriate.
• Oversee proficiency testing and external quality assessment for molecular assays; investigate failures or discordant results implement corrective actions and document findings for internal review and external clients.
• Lead or support responses to client audits regulatory inspections and duediligence reviews including preparation of technical documentation metrics and presentations describing molecular testing capabilities and quality performance.
• Promote a culture of scientific rigor datadriven decisionmaking and continuous improvement mentoring supervisors and senior technologists and providing technical escalation for complex issues.
• Demonstrate strong communication and collaboration skills.
• Strong leadership skills including across cross functional teams.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.
• Support and comply with the companys Quality Management System policies and procedures.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• May require flexible hours or occasional oncall availability to support global operations critical instrument or pipeline issues validations and client or regulatory audits across time zones.
• Ability to work nights and/or weekends as needed).
• Ability to work on a mobile device tablet or in front of a computer screen and/or perform typing for approximately XX% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials tissue specimens and instruments with moving parts lasers heating and freezing elements and high-speed centrifugation.
• Requires the ability to move throughout the laboratory stand and walk for portions of the day and occasionally lift or move laboratory supplies and equipment consistent with molecular highthroughput operations.
• Ability and means to travel 10% between Madison / Redwood City) locations.
• Ability to travel 10% of working time away from work location may include overnight/weekend travel.
• You will be required to successfully complete an assessment showing understanding of Exact Sciences Epic processes necessary to the job functions with a score of 80% or higher. Exact Sciences will make a reasonable accommodation available if necessary to assist an employee with a disability to satisfy this requirement.

Minimum Qualifications

• Doctoral degree (PhD MD DO) in molecular biology genetics pathology clinical laboratory science or a closely related discipline strongly preferred for highcomplexity molecular directorship with 5 years experience indicated.
• Or a minimum of a bachelors or masters degree in medical laboratory science molecular biology genetics or related field that meets CLIA educational requirements for highcomplexity technical supervisor/section director plus substantial molecular diagnostics experience with 8 years experience indicated.
• Board certification in a relevant discipline (e.g. ABMGG ABP in Molecular Genetic Pathology ABCC Antomical Pathology Clinical Pathology or equivalent) highly preferred especially when serving in a broader directorship capacity.
• 5 years of progressively responsible experience in highcomplexity clinical molecular diagnostics including substantial experience in a highthroughput or commercial reference laboratory environment.
• 3 years experience with laboratory automation robotics LIMS integration and highvolume workflow optimization in a commercial or centralized testing environment.
• Demonstrated expertise in validation verification and ongoing performance management of molecular assays (e.g. PCR NGS panels molecular microbiology oncology genetics) and associated bioinformatics pipelines.
• Deep knowledge of molecular diagnostics principles technologies and regulatory expectations including NGS pipeline metrics variant calling and annotation concepts and molecular microbiology or oncology as applicable to the menu.
• Strong understanding of CLIA highcomplexity personnel validation QC and documentation requirements as they apply specifically to molecular methods and highthroughput environments.
• Demonstrated leadership skills with the ability to manage crossfunctional teams (technical supervisors senior technologists data/bioinformatics teams and quality) and drive results in a fastpaced commercial setting.
• Excellent analytical and problemsolving abilities including troubleshooting complex molecular assays automation issues and data quality anomalies across large datasets.
• Strong communication skills including the ability to explain complex molecular and bioinformatics concepts to nontechnical stakeholders and international clients.
• Familiarity with LIMS middleware automation control software and basic bioinformatics or dataanalytics tools; comfort working with large data sets and operational dashboards.
• Ability to balance scientific rigor regulatory compliance commercial timelines and client expectations across multiple regions and time zones.
• Possession or ability to obtain appropriate state license within 3 months of hire and maintain throughout employment in position for directing or supervising highcomplexity clinical molecular testing if required by the state where the laboratory is located.
• Advanced computer skills to include internet navigation and email usage.
• Advanced in Microsoft Office programs such as Word Excel PowerPoint Outlook.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Preferred Qualifications

• 3 years experience managing CLIA highcomplexity and accreditation requirements (and where applicable international client or ISOaligned expectations) including inspections audits proficiency testing and corrective action programs.
• Professional certification such as MB(ASCP) MLS(ASCP) with molecular specialty or equivalent strongly preferred for technical leadership.

Salary Range:

Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation holidays volunteering and personal time) paid leave for parents and caregivers a retirement savings plan wellness support and health benefits including medical prescription drug dental and vision coverage. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation please contact us here.

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