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Sr. Principal Medical Affairs Director

External
Exact Sciences logoExact Sciences · - CA - Redwood City
Full-timeOn-site2w ago
Clinical TrialsComplianceLeadership
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Vision insurance

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Help us change lives 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. Position Overview The Sr. Principal Medical Affairs Director, MRD is responsible for clinical leadership in the development and execution of Exact Sciences, now Abbott Cancer Diagnostics Molecular Residual Disease (MRD) commercialization strategies. This includes but is not limited to, the development, validation, and regulatory approval of diagnostic tests designed to help determine the most appropriate therapies for patients, monitor therapy effectiveness, and detect the presence of residual disease. In partnership with Product Lifecycle Management and Strategy, this role provides oncology leadership during the design, development, and implementation of studies that support on-market MRD products. This role develops external relationships with leaders in academic oncology, cooperative trial groups, and research organizations, as well as identifies investigators and sites to participate in clinical trials and inform medical strategies. The Sr. Principal Medical Affairs Director, MRD initiates and leads external advisory boards involving medical leaders in pharma, key opinion leaders, and other third parties. The Sr. Principal Medical Affairs Director, MRD is responsible for the review, interpretation, and leadership in the reporting of key study results and helps design and implement the medical support for MRD-related commercialized products. The Sr. Principal Medical Affairs Director, MRD is a member of the Medical Affairs team and is both a leader of and participant on internal cross-functional program teams and working groups including, but not limited to, members of the business development, pathology and clinical lab operations, biostatistics, clinical affairs, regulatory, market access, and commercial teams. This position may be based in Redwood City, CA, or may be field-based. Essential Duties Include, but are not limited to, the following: Develop the overall vision and strategy for the commercialization of the molecular residual disease (MRD) liquid biopsy portfolio, in partnership with internal and cross-functional stakeholders including commercial, medical development, compliance, and regulatory teams. Provide medical expertise on new products and services to guide the commercialization strategy designed by a cross-functional team including the research and development, oncology medical development, pipeline, and commercial organizations. Engage with medical leaders within the field of precision and molecular medicine as well as medical, surgical, and radiation oncology to gain a greater understanding of key clinical questions in patient management, clinical tool needs, and facilitate their understanding of the scientific validity and clinical utility of Abbott Cancer Diagnostics' MRD-related products. Accountable for the initiation, accuracy, and delivery of scientific presentations and publications generated through commercialized precision oncology product collaborations. Provide oncology expertise and clinical insight for cross-functional teams at Abbott Cancer Diagnostics throughout the lifecycle of practice-changing genomic tests and services. Engage with colleagues in the medical organization to drive continuous improvement of team leadership practices including, but not limited to, department communications, interview potential new team members, team-building initiatives, and enhancement of Abbott Cancer Diagnostics' culture. 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 travel up to 60% of working time away from work location, may include overnight/weekend travel. M inimum Qualifications M.D., D.O., or Ph.D. in a related field as outlined in the essential duties. Completion of fellowship training in oncology. Demonstrated expertise in molecular oncology. Demonstrated ability to lead cross-functional internal and external teams of professionals focused on complex, multi-faceted projects. Familiarity with laboratory analytical process development and biostatistics. Strong communication skills; ability to create and maintain open, clear, and collaborative communication with internal stakeholders, senior management, external partners and customers, and key opinion leaders. Demonstrated ability to build and lead internal and external collaborations. Demonstrated ability to integrate and apply feedback in a professional manner. Demons


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