Director, Medical Affairs

What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.

Position Summary                  

Illumina, Inc. is seeking a board-certified molecular genetic pathologist with extensive leadership experience in molecular screening and diagnostic testing for cancer. This position is within the AMR Medical Affair organization, reporting to the Senior Medical Affairs Director for Oncology. This role will have responsibility for informing oncology-related product development, patient safety risk assessments and regulatory submissions, guiding medical research in oncology, overseeing clinical diagnostics for companion diagnostics development, supporting interactions with biopharma collaborations in oncology, and participating in medical education in molecular screening and diagnostics for cancer. The individual in this role will represent Medical Affairs within cross-functional teams focused on cancer screening and diagnostics, working closely with Commercial, Business Development, Pharma, R&D, Product Marketing, Regulatory, Bioinformatics, Assay Development, and Quality teams.

The ideal candidate has held leadership positions at molecular pathology laboratories utilizing next-generation sequencing technologies for Illumina oncology solutions. This individual has a strong background in molecular and cytogenetic methods used for cancer diagnostics for solid tumors and hematological malignancies. These methods include complete genomic profiling of solid tumors, cell-free tumor DNA (liquid biopsy) analysis, minimal residual disease monitoring, hereditary cancer screening and diagnostics using germline next-generation sequencing, and pharmacogenomics. The candidate must have excellent understanding of the trends in professional practice in molecular oncology in the United States and a wide network of connections with key opinion leaders. The candidate must have demonstrably intimate understanding of the trends in next-generation sequencing, clinical laboratory practices and their regulatory oversight, and technologies broadly deployed in molecular screening and diagnostics in cancer care. The candidate must have demonstrated leadership in cancer research and publications that have contributed to advancing clinical management of individuals going through their cancer journeys.

Position Responsibilities

• Represent Illumina’s medical affairs by providing leadership and clinical expertise in interactions with Illumina’s sales and marketing, business development and other commercial functional groups, as needed
• Actively participate in the product development process in R&D to guide specifications for Illumina’s RUO and IVD products. Work closely with Marketing, Marketing Development, Assay/Product Development as well as product life cycle team to support the execution of the product launch strategy, and ensure internal and external launch readiness
• Lead the development of AMR medical affairs strategies for evidence generation and scientific communication for cancer screening and diagnostics
• Together with the Head of Strategic Clinical Research in Medical Affairs, support development and execution of a comprehensive portfolio of high-caliber medical collaborative research in cancer screening and diagnostics
• Collaborate with Market Access to strategize and develop the necessary evidence to improve reimbursement for cancer screening and diagnostics
• Represent medical affairs by providing leadership and clinical expertise in interactions with pharma/biotech partners
• Lead the development of scientific and medical education content and in-house training for the medical affairs team and other appropriate staff as required, and ensure suitability of training content for clinical specialists in collaboration with Marketing and other relevant internal stakeholders 
• Develop best practices and build sustainable partnerships with US key opinion leaders to ensure that Illumina’s cancer screening and diagnostics portfolio is appropriately incorporated and positioned in clinical care guidelines by providing balanced, non-commercial scientific information.
• Prepare tailored clinical presentations for Illumina’s advisory boards, col