Principal Scientist, Test Implementation and Launch, Technical Services

$152,000 - $242,000/Yr

Exact Sciences - Madison, WI

Full-time - Senior

Madison, WI

Professional, Scientific, and Technical Services

About the position

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. The Principal Scientist, Test Implementation and Launch, Technical Services will lead one or more cross-functional 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 position is onsite in Madison, WI.

Responsibilities

• 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, pre-analytical and analytical scientists, operations managers, lab automation, and support teams.
• Provide experience-based input to development, medical, and commercial teams for development, implementation, and full-service stack for clinical test commercialization, drive decisions affecting project plans and experimental designs to ensure clinical performance and utility are established and maintained.
• 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.
• 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.
• 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 execution, data analysis, and reporting.
• Ensure effective representation of voice of the lab customer to cross-functional 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 Exact's 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 company's Quality Management System policies and procedures.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

Requirements

• Bachelor's 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.
• Demonstrated leadership launching both in-vitro diagnostic (IVD) and laboratory-developed 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.

Nice-to-haves

• 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, commercial laboratory ordering and resulting by both electronic and paper means, analytical and clinical validation, FDA-approved, laboratory-developed, and New York State approved tests.
• Demonstrated proficiency in molecular biology techniques including Real-Time- polymerase chain reaction (PCR) Assays and next-generation sequencing.

Benefits

• Paid time off (including days for vacation, holidays, volunteering, and personal time)
• Paid leave for parents and caregivers
• Retirement savings plan
• Wellness support
• Health benefits including medical, prescription drug, dental, and vision coverage