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The Clinical Development Scientist, Clinical Affairs is responsible for the development of clinical evidence plans, clinical development strategies, and study designs to support clinical validation and clinical utility of in vitro-diagnostics (IVD) products. This position works with cross-functional study teams to design and execute clinical studies, including protocol development, data interpretation, clinical study report writing, and scientific communication (e.g., abstracts, publications, presentations).
The Senior Product Manager will be a key member of the team responsible for defining product and services strategy, scope, and design decisions for Thrive’s earlier detection product portfolio using inputs from customers and key internal stakeholders including, but not limited to, product development, medical affairs, regulatory, clinical development, sales & business development, and marketing. This role will be a key member of product development core teams and will guide the team to ensure the right solution is built and launched for the right markets. This role will work cross-functionally, partnering with various functional stakeholders to lead efforts in developing a total solution, products, and services, that meets the needs of customers and patients.
This position can be based in Cambridge MA or remote.
The IT QA Validation Analyst is responsible for providing quality assurance and computer systems validation support activities across the IT department of Exact Sciences. The IT QA Validation Analyst will contribute to the development of standard processes and procedures for software applications and computer systems that are managed by IT. The IT QA Validation Analyst is responsible for implementing and maintaining these standard processes and contributing to IT process improvement projects. This role interacts with cross-functional groups across Exact Sciences to ensure the IT quality processes align with the quality processes in other areas of the business.
The IT Project Manager plans, directs, and coordinates activities of corporate projects to ensure that goals or objectives of projects are accomplished within the prescribed time frame and funding parameters. This position ensures that project goals are accomplished and in line with business objectives.
The IT Quality/Business Analyst is a member of the Information Technology (IT) team. This role fulfills both the business analyst and quality analyst roles for applications and systems development. The IT Quality/Business Analyst will shape the technology demands and drive quality among the Exact Sciences business community. The IT Quality/Business Analyst acts as an intermediary between IT project teams and business partners; including, but not limited to, define, analyze, and translate business requirements into documentation and conceptual design with the use of the appropriate tools and models from which applications and solutions are developed. This role functions as the stakeholder and user advocate to understand their requirements and represent their interests to work with the implementation team. This role will execute the test strategy to provide objective evidence that system and application requirements are met. This role will be hands-on and require strategic reason and plans to ensure all requirements are met for overall quality of the intended solutions both functionally and technically.
The Senior Project Manager, Real Estate and Construction will be responsible for hands-on management of all facets of pre-construction, bid and award, construction, and close-out phase of all assigned projects. The Senior Project Manager, Real Estate and Construction will facilitate and represent multiple stakeholder groups in working with design and construction partners and routinely report project status to project sponsors and team members.
This position is responsible for working directly with hiring managers to develop a proactive approach to attract and retain top talent across Exact Sciences and Exact Sciences Laboratories. The Recruiter will be responsible for leading all aspects of the Talent Acquisition Process including strategy implementation, sourcing, screening, and employment offer development.
The Clinical Curation Scientist will work within a team of clinical professionals to perform genomics knowledge mining and content derivation supporting Exact Sciences’ precision medicine platform. The Clinical Curation Scientist will collaborate with genomics and clinical teams to develop and implement an interpretive genomics guided therapy report that is informative and clinically relevant.
The Director, Clinical Quality and GCP Compliance is part of the clinical affairs team, which is responsible for planning, executing, managing, and closing projects associated with the company clinical study plans. This role will partner with the clinical affairs leadership team to drive clinical quality assurance (CQA) activities to include internal, vendor, and site audits, SOP development and review, process improvement, and training assessment. This position will also oversee the training team within clinical affairs. The Director, Clinical Quality Assurance and GCP Compliance will serve as an advisor to clinical affairs project teams, cross-functional leadership, and stakeholders for adherence to quality and compliance standards. This role will also provide leadership and support to members of multidisciplinary project teams, both internally and externally, and will provide professional development and guidance to assigned clinical affairs team members.
The Senior Maintenance Technician is responsible for operating, maintaining, troubleshooting, and repairing facility related mechanical, electrical, instrumentation, refrigeration, control systems, and equipment located within office, R&D, and GMP manufacturing locations. Additionally, this position supports automated fill, cap, and labeling, conveying, and product finishing equipment from set-up, to change-over and supports associated maintenance and troubleshooting as requested.
The Materials Management/Distribution Associate I will assist in a variety of Materials Management functions, including, but not limited to, requisitioning, inventory management, packaging, shipping, receiving, and distribution of goods and supplies. This position will work within defined protocols and procedures. This role will also complete a variety of transportation duties with an emphasis on inter-office material movements. This position is ideal for a self-starter who is comfortable fulfilling a wide variety of job responsibilities.
This role is Sunday - Thursday, 10:00pm - 6:30am.
The Supervisor, Research, with limited guidance from more experienced scientists, works individually and in collaboration with others on multiple projects which are moderate to complex in scope. This position plays an active role in the planning of projects and experiments and is often the technical lead responsible for the successful execution of the project. The Supervisor, Research will primarily be involved in early research and discovery projects, serving as a technical lead in translating research ideas and concepts into the product development pipeline. This position provides leadership to a team of junior research associates by defining clear and realistic goals, clearing barriers to success, and understanding of skills and tasks associated with successful execution. 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.
The Clinical Laboratory Quality Assurance (QA) Specialist is responsible for many quality issues in the clinical laboratory, including developing, implementing, and maintaining a quality management system, ensuring compliance with all regulatory requirements, and facilitating feedback monitoring and resolution for customer satisfaction, and non-conforming event management. The Clinical Laboratory QA Specialist will monitor effectiveness of the quality management system, support continuous improvement opportunities, and educate the workforce on applicable procedures and regulations.
The Associate Director, Applied Data Science will lead Thrive Health Economics and Outcomes Research (HEOR)’s real world evidence (RWE) data strategy to define the strategy, perform data analysis, and communicate RWE results to various stakeholders, such as the Food and Drug Administration (FDA), Center for Medicare and Medicaid Services (CMS), private payers, and the U.S. Preventative Services Task Force (USPSTF), with the end goal of achieving broad coverage and favorable reimbursement for Thrive’s multi-cancer detection products and integrated support services.
The Associate Director, Applied Data Science will collaborate heavily with internal and external HEOR stakeholders to include key opinion leaders (KOLs) to address government, provider, payer, and internal company HEOR needs. This position will work cross-functionally to tailor RWE endpoints and messaging appropriately to the applicable stakeholders, effectively communicating and presenting complex technical concepts and quantitative analyses to both internal and external executive audiences. This position will set RWE strategies with expertise in the design and application of RWE generation projects during all phases of product life cycles, but especially in earlier phases to include premarket approval (PMA) submissions and early lifecycle coverage determinations.
The Data Scientist performs data analysis to extract knowledge or insight from structured or unstructured data. This position will apply advanced statistical algorithms for analysis of large-scale, complex datasets. This position will keep up to date with cutting-edge techniques in programming, machine learning, big data, and healthcare modeling and will seek ways to advance the organization’s capabilities in analytics.
The Senior Analyst, Business Analytics is responsible for analyzing the performance of the brand and the execution of the commercial channels that propel the brand, by developing key strategic initiatives, and aligning on KPIs. The tasks include strategizing, processing, and organizing data, synthesizing data, and performing descriptive and predictive analyses, and creating reporting dashboards. This role will provide key insights to business partners within commercial organizations to inform business decisions. The team deploys a variety of exciting analytical software and techniques that the analyst will be able to simultaneously use and learn.
The Product Lifecycle Manager, MAP Tissue will be responsible for product strategy and lifecycle management of the on-market Oncotype MAP Pan-Cancer Tissue test and related variations. This position will be responsible for the product definition, intended use, market requirements, business model, market entry roadmap, and marketing strategies of on-market products to enable continued growth and evolution over its lifecycle.
The Product Lifecycle Manager, MAP Tissue will identify line extension opportunities, indication expansion, and the timing of product end-of-life. This position will accomplish these tasks by relying on a deep understanding and knowledge of customer needs, market trends, and competitive pressures, as well as establishing short and long-term objectives and plans that transform the product strategy into clear measurable results. The Product Lifecycle Manager, MAP Tissue will be responsible for driving the team towards execution of these plans and will accomplish tasks through interactions with a broad range of functions involved with the development and commercialization of Exact Sciences products including research and development (R&D), clinical, operations, program management, commercial, pipeline business unit (BU), international BU, finance, regulatory, and legal functions. This position will collaborate with and influence varying levels of internal and external personnel with a strong team-focused approach, direct interactions with customers, and public presentations.
The Laboratory Service Optimization Engineer is responsible for the initial service of new equipment during the post launch phase and working to optimize the service until transitioning the full service to the whole Instrument and Automation Services team. This role will also be an integral point of integrating service needs for new laboratories. The Laboratory Service Optimization Engineer will work closely with new laboratory projects that effect the equipment support as a core team member to ensure we drive in our service requirements.
The Laboratory Service Optimization Engineer is expected to develop a working knowledge of all Exact Sciences laboratory processes and associated systems. They will participate in cross-functional teams working in a variety of areas, including Process Engineering, Assay Chemistry, our Clinical and Development Laboratories, Program Management, Research, Analytical Sciences, Manufacturing, Quality Assurance, and other groups.
This is an excellent opportunity for a team player to participate in the growth of a fast-paced, pioneering company that is developing systematic approaches to applying genomic technology to health, disease, and medical practice.
The IT Program Manager will successfully deliver solutions to support the organization’s vision and strategic direction. This role will manage and lead large, high risk, high visibility, and critical projects across the organization. These projects are often highly complex and impact many users. The IT Program Manager is a hands-on role that requires close collaboration with all levels of Exact Sciences to ensure successful integration and communication between multiple projects.
The Senior Associate Scientist, Technical Transfer will lead or assist in a variety of technical transfer and continuous improvement activities that facilitate process and product transfer into operations. This position will develop, document, validate, and implement new processes and procedures into production as part of the design transfer process.