Associate Director, Investigations, Technical Services

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At Exact Sciences, we're 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 purpose-driven career, an inclusive culture, and robust benefits to support your life while you're working to help others.

Position Overview

The Associate Director, Investigations, Technical Services leads the most complex investigations including overlapping and interdependent problems. This role will be responsible for the technical approaches, organization, structure, execution, analysis, documentation, and effectiveness of investigations of test systems or components. This role will draw on a large library of organizational, experimental, and analytical approaches to problem identification and resolution such as DMAIC, BADIR, PDCA and know when and how to apply the most effective tools and frameworks to problems that arise in a complex clinical lab setting.

Essential Duties

Include, but are not limited to, the following:

• Lead and guide other scientists in troubleshooting of customer issues through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Train/Lead other Incident Commanders and act as Incident Commander, the single point-of-contact and responsible party for a critical investigation to manage patient safety, operational mitigation, and ultimate resolution through prompt action, cross-functional partnership, and thorough communication.
• Lead prompt application of appropriate frameworks to problems as they arise as managed by Investigation teams, recognizing the underlying business objectives such as patient safety, clinical need, overall quality, operational impact, and effectiveness.
• Oversee preparation of detailed technical protocols for investigation.
• Direct and review technical experiment reports and present to Director+ audiences, project teams, and external quality or regulatory agencies.
• Oversee quality and content accuracy of training programs for internal and external customers.
• In the context of the company's portfolio of products, provide business justification, lead, and report effectiveness of improvements in processes and products.
• Ensure the quality and effectiveness of the content of customer communications, customer notifications, and technical or service bulletins. Review, edit, and approve such content created by others.
• Ensure the department effectively represents the voice of the lab customer to cross-functional stakeholders including Development, Marketing, Finance, IT, and Quality for new products and revisions to existing products.
• Identify gaps in processes, make recommendations, and implement change.
• Develop or participate in publication strategies and overall technical communications within Exact.
• 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.
• Summarize and document troubleshooting activities or technical summary for Director+ audiences.
• Ability to communicate clearly, frequently, and accurately in person, via the telephone, or by email.
• Ability to work independently.
• Apply advanced analytical and troubleshooting skills.
• Apply strong communication and organizational skills.
• Apply high complexity problem-solving abilities to provide technical input, design experiments, propose product enhancement ideas and voice of customer (VOC).
• 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.

Minimum Qualifications

• 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, clinical laboratory, or molecular diagnostic R&D role including problem investigation and resolution.
• 9+ years of leadership experience with direct responsibility for performance management, development, coaching, hiring, and training direct reports.
• Demonstrated advanced proficiency or coursework with molecular biology techniques and Real-Time- polymerase chain reaction (PCR) Assays and next-generation sequencing techniques.
• Demonstrated advanced knowledge of clinical lab regulations such as College of American Pathologists (CAP), clinical laboratory improvement amendments (CLIA), in-vitro diagnostic regulation (IVDR), and food and drug administration (FDA).
• Demonstrated understanding of statistical and mathematical methods in biology or genetics.
• Advanced data analysis skills and analytical aptitude.
• 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 experience in troubleshooting molecular diagnostic tests in multiple clinical laboratories.
• Demonstrated proficiency in molecular biology techniques such as Real-Time polymerase chain reaction (PCR) Assays and next-generation sequencing techniques.
• Experience with audits conducted by federal or state agencies (i.e. FDA/CMS), and/or accreditation bodies (i.e. CAP), and investigations involving correction or amendment to patient results.

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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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law. Any applicant or employee may request to view applicable portions of the company's affirmative action program.

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