Associate Lab Director, PO Medical

## Principal Associate Lab Director, PO Medical Apply locations:
US - WI - Madison time type:
Full time posted on:
Posted Todayjob requisition :
R26-13538
** 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, on‐time 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 on‐call availability to support global operations, critical…