Principal Clinical Data Innovation Architect

Job title: Principal Clinical Data Innovation Architect

Company: Exact Sciences Corporation


Job description: Help us change livesAt 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.We’re excited to introduce a new, future-focused opportunity: Principal Clinical Data Innovation Architect. In this pivotal role, you’ll help power our Data Flywheel—accelerating progress with each turn to deepen our patient impact. From pioneering new cancer diagnostics to enhancing existing tools, uncovering unmet clinical needs, and driving greater scalability and efficiency, your work will shape the future of cancer care.We’re looking for a visionary leader who pairs bold thinking with strong execution. If you’re ready to push the boundaries of what’s possible, join us in our mission to help eradicate cancer. With a portfolio that supports patients throughout their cancer journey, Exact Sciences offers a unique platform to turn that mission into reality.Position overview:The Principal Clinical Data Innovation Architect will lead the exploration, introduction and scale up of innovative approaches to collect and combine internal and external data to improve the speed, quality and cost-efficiency of data-driven analyses along the product lifecycle. This includes, but is not limited to, the creation of novel clinical genomic data assets for research and discovery, Real-World Data access for clinical validation and / or for post-marketing studies, and the creation of novel data assets from the combination of existing data sets along the product lifecycle and across the Exact Sciences product portfolio. This position will enable building upon the most advanced scientific research concepts, technologies, and future-proof data standards to establish a continuous scientific-data and evidence spectrum across the entire Exact Sciences portfolio and along the entire cancer journey. In partnership with Clinical Affairs, Medical Affairs, Regulatory Affairs, and Commercial across both Business units this role will help formulate the next problem statement in the cancer journey for the Science Office and its business partners then by partnering with the AI Research will mine data with advanced AI and ML methods. Reporting to the SVP, Bioinformatics, Biostatistics, Data Innovation & Medical Informatics, the Principal Clinical Data Innovation Architect will foster close collaboration across the team, the Science Office, its business partners and senior leadership. This position will serve as both a technical and though-leader that supports leadership in formulating strategy to define clear and realistic goals, clearing barriers to success, identifying and evaluating technologies and partnerships in the field, creating a clear view of business value of assigned projects and how they fit into the long-term objectives of the organization. This person is also responsible for supporting a collaborative environment that promotes positive teamwork where all members are working for the good of Exact Sciences, and demonstrates outstanding clinical data sciences skill, strategic and transformative thinking, collaboration, and communication.Essential DutiesInclude, but are not limited to, the following:

• Lead the evaluation and implementation of cost-effective, cutting-edge data and systems solutions to capture and link real-world data for clinical studies.
• Develop and implement a comprehensive strategy for leveraging clinical and real-world data to enhance cancer diagnostics, improve patient outcomes, and support regulatory decisions.
• Supporting Clinical Affairs to evaluate and implement innovative systems to bring new capabilities, save cost, enable scaling, and/or further efficiency.
• Partner with Regulatory Affairs in identifying and evaluating innovative systems and solutions that address the unmet needs in the function
• Partner with the Clinical Affairs and Regulatory Affairs to identify the opportunities where AI can help in improving the quality, reducing cost, and increasing the throughput of the functions.
• Maintain primary vendor relationships and assess new technology companies that serve Clinical Affairs and Regulatory Affairs needs.
• Bridge between Clinical Affairs and AI research team in formulating the data requirements for AI solutions to clinical problems in cancer diagnostics.
• Collaborate with Clinical Affairs leaders and initiative leads to identify high-impact opportunities for data-driven innovation in clinical trials and real-world evidence projects.
• Oversee the integration of diverse data sources, including digital pathology images, proteomics, genetics, epigenetics, and electronic health records, to develop novel diagnostic tools.
• Coordinate with Regulatory affairs to ensure compliance with regulatory (e.g. FDA, EMA IMDA, etc.) requirements real-world data and evidence utilization.
• Partner with AI Research to Employ classic and cutting-edge AI and ML technologies for data mining, and classification.
• Lead the user requirements collection and analysis to develop and enhance software platform for rapid integration and interrogation of data, hypothesis testing.
• Promote and Champion making Complex Data intuitive by using advanced and interactive data visualization techniques.
• Build system interoperability with internal and external EMR/EHR systems, biorepositories, bioinformatics pipelines and other critical data exchanges in partnership with R&D Software and IT.
• Identify, research, and report on industry trends, competition, and shifting scientific research and regulatory landscapes to inform strategies.
• Advise business leaders by providing data to identify and address scientific research opportunities.
• Work in collaboration with other business leaders to drive decisions based on data, facts, and analytical findings.
• Lead, manage, and execute ad-hoc cross-functional strategy/consulting projects involving research, external consultants, and internal cross-functional teams.
• Attend tradeshows/industry events, as appropriate, for tracking trends and competition.
• Communicate clearly and frequently within the Science office functions; also proactively engage as needed with functions across both Screening and Progression Oncology Business, IT, and other corporate functions.
• 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 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 and means to travel X% between (select one: local Exact Sciences / Madison / Redwood City) locations.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Ph.D. in Life Sciences or field as outlined in the essential duties; or master’s degree in Life Sciences, Business Administration, or field as outlined in the essential duties and 3 years of industry experience in lieu of Ph.D.; or bachelor’s degree and 5 years of industry experience in lieu of Ph.D.
• 5+ years of experience leading clinical systems and data teams.
• 3+ year experience with relevant data standards such as CDISC Data Exchange (ODM) / Medical Device standards (CDISC-Advamed), HL7, DICOM, and NGS data exchange formats.
• 5+ years of supervisory or project team lead experience with demonstrated ability to lead, develop, and train team members effectively.
• Advanced skills in the design of data collection, data transfer, and data management systems in validated environments.
• Proficient in working with PPRL methods/technology for real world data methods and technologies such as Tokenization.
• 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

• Ph.D. in Computer Science, Data Science, Biology, Biochemistry, or related field.
• 5+ years of relevant work experience with demonstrated success in decentralized trials or studies utilizing real-world data.
• 5+ years of experience working in the health care field, diagnostics, pharmaceuticals or related field, with demonstrated ability to effectively contribute toward team goals.
• Experience and success with decentralized trials.
• 3+ years of in Data Engineering and Data architecture design for organizing clinical, medical, and analytical data.
• Experience in working with modern AI/ML models such as LLM and Deep Learning.
• Experience in working with Next Generation Sequencing genetic data.
• Experience in complex data visualization.
• Experienced patient privacy regulations such as HIPA and GDPR.
• Familiarity in compiling data packages to support PMA submission for Diagnostic Medical Devices.
• 3+ years of experience in Cancer testing and Diagnostics.

#LI-CL1Salary Range: $182,000.00 – $309,000.00The annual base salary shown is a national range for this position on a full-time basis and may differ by hiring location. In addition, this position is bonus eligible, and is eligible to be considered for company stock at hire and on an annual basis.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 .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 .Not ready to apply? Join our to stay updated on the latest news and opportunities at Exact Sciences.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.To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our . The documents summarize important details of the law and provide key points that you have a right to know.

Expected salary:

Location: San Diego, CA

Job date: Thu, 03 Jul 2025 07:37:00 GMT

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