Associate Director Test Launch Technical Services

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At Exact Sciences were helpingchange 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 purposedriven career an inclusive culture and robust benefits to support your life while youre working to help others.

Position Overview

The Associate Director Test Launch Technical Services will lead one or more crossfunctional teams to ensure the full test system as deployed in the clinical laboratory meets all quality operational and analytical performance requirements. This includes accountability for coordination of R&D automation operations quality and supply chain/production personnel to implement procedures methods equipment training monitoring and any other processes or systems required for clinical test success. Success will be defined by a balanced scorecard of quality safety efficiency and delivery metrics after the test is live.

This is position is for Madison WI.

Essential Duties

Include but are not limited to the following:

• Manage full life cycle of multiple new or revised clinical laboratory tests from development into successful clinical deployment.
• Oversee multiple overlapping programs ensuring the coordination of technology transfer from multiple R&D production and IT teams to the many lab teams including supply chain quality IT preanalytical and analytical scientists operations managers lab automation and support teams.
• Provide experiencebased input to development medical and commercial teams for development implementation and fullservice stack for clinical test commercialization drive decisions affecting project plans and experimental designs to ensure clinical performance and utility are established and maintained.
• For multiple tests at various stages of commercialization ensure analytical and clinical validation activities are planned appropriately to the intended use and commercial context of the test are resourced appropriately and produce expected outputs including validation reports publications quality programs and support materials (e.g. reference standards).
• Lead complex projects representing Lab Operations on core teams of complex products or products of >100k tests/year volume.
• Develop or participate in publication strategies and overall technical communications within Exact.
• Report to Director audiences on launch progress including identification and resolution of gaps assessing and mitigating risks actively directly and through influence to other departments.
• Provide business justification lead and manage improvements in processes and products with full accountability to ensure outcomes are in line with justification.
• Lead and guide other scientists in troubleshooting of customer issues through root cause investigation experiment design study data analysis and reporting.
• Train and mentor team members taking responsibility for their success and the quality and accuracy of their work products.
• Effectively manage support and guide your team including but not limited to. delegating tasks and responsibilities assessing employee performance and providing helpful feedback and training opportunities.
• Consistent demonstration of exceptional leadership qualities including but not limited to the ability to attract and retain the best team foster a culture of high performance lead with integrity humility accountability and courage and set a clear vision to energize teams towards the future.
• Directly or indirectly ensure effective representation of voice of the lab customer to crossfunctional stakeholders including Development Marketing Finance IT and Quality for new products and revisions to existing products.
• Oversee and ensure quality and effectiveness of training program development for internal and external customers
• Contribute ideas or drive improvements to team processes.
• Assume responsibility for the quality and accuracy of all work products in Technical Services as well as the safety and accuracy of Exacts clinical tests.
• Ability to communicate clearly frequently and accurately in person via the telephone or by email.
• Ability to work independently.
• Apply advanced business and quality analysis tools.
• Apply strong communication and organizational skills.
• Ability to maintain confidentiality of sensitive information.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work a designated schedule.
• Ability to work on a mobile device tablet or in front of a computer screen and/or perform typing for approximately 90 of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to travel 35 of working time away from work location may include overnight/weekend travel.
• Maintain regular and reliable attendance.
• Receive and document incoming customer communications.
• Work cooperatively with the technical services team and internal functional departments to troubleshoot and resolve customer questions or requests related to reagents consumables and assay issues.
• Support and comply with the companys Quality Management System policies and procedures.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.

Minimum Qualifications

• Bachelors Degree in life sciences or related field.
• 10 years of experience in the life sciences or clinical diagnostics industry.
• 10 years of experience working in a molecular diagnostic or clinical laboratory 5 years of experience leading new clinical test launches including validation training documentation facility and equipment readiness.
• 8 years of leadership experience with direct responsibility for performance management development coaching hiring and training direct reports.
• Demonstrated leadership launching both invitro diagnostic (IVD) and laboratorydeveloped tests (LDTs) in a commercial clinical lab environment.
• Demonstrated advanced knowledge of clinical lab regulations such as College of American Pathologists (CAP) clinical laboratory improvement amendments (CLIA) or international equivalents.
• Proficiency in Microsoft Office programs such as Word Excel PowerPoint Outlook Access and OneNote.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• Advanced degree (Ph.D. M.S. etc. in biology chemistry physics engineering or a related field.
• 15 years of experience in launching molecular diagnostic tests in many different laboratories.
• Successful launch of >100 clinical diagnostic tests with a variety of IT systems specimen collection structures (i.e. IOP draw sites mobile phlebotomy) commercial laboratory ordering and resulting by both electronic and paper means analytical and clinical validation FDAapproved laboratorydeveloped and New York State approved tests.
• Demonstrated proficiency in molecular biology techniques including RealTime polymerase chain reaction (PCR) Assays and nextgeneration sequencing.

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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