Principal Associate Lab Director, PO Medical

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Principal Associate Lab Director, PO Medical is responsible for the technical and scientific oversight of all high‑complexity molecular testing in a high‑throughput 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 large‑scale, high‑throughput workflows and automation, in accordance with CLIA high‑complexity 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, ISO‑aligned client expectations) for high‑complexity 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 turnaround‑time 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 due‑diligence reviews, including preparation of technical documentation, metrics, and presentations describing molecular testing capabilities and quality performance. Promote a culture of scientific rigor, data‑driven decision‑making, 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 company’s 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 high‑throughput operations. Ability and means to travel 10% between Madison and 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 high‑complexity molecular directorship with 5+ years experience indicated. Or a minimum of a bachelor’s or master’s degree in medical laboratory science, molecular biology, genetics, or related field that meets CLIA educational requirements for high‑complexity 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, Anatomical Pathology, Clinical Pathology or equivalent) highly preferred, especially when serving in a broader directorship capacity. 5+ years of progressively responsible experience in high‑complexity clinical molecular diagnostics, including substantial experience in a high‑throughput or commercial reference laboratory environment. 3+ years experience with laboratory automation, robotics, LIMS integration, and high‑volume 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 high‑complexity personnel, validation, QC, and documentation requirements as they apply specifically to molecular methods and high‑throughput environments. Demonstrated leadership skills with the ability to manage cross‑functional teams (technical supervisors, senior technologists, data/bioinformatics teams, and quality) and drive results in a fast‑paced commercial setting. Excellent analytical and problem‑solving 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 data analytics 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 high‑complexity 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 high‑complexity and accreditation requirements (and, where applicable, international client or ISO‑aligned 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: $184,000.00 - $314,000.00 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. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law. #J-18808-Ljbffr