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 medical professional with board certification in clinical molecular genetics and cytogenetics and extensive experience in developing genomic tests for hereditary diseases and cancer. This position is within Illumina’s Medical Affairs organization, reporting to a global medical director. This role will be responsible for actively contributing to product development in Illumina’s R&D organization, conducting patient safety risk assessments for Regulatory and Quality teams, supporting product submissions for regulatory approvals, companion diagnostics development for pharma collaborations, and participating in medical education on molecular screening and diagnostics for hereditary diseases and cancer. The individual in this role will represent Medical Affairs within cross-functional teams focused on developing Illumina’s instruments, assays, or software for disease screening and diagnostics and, as necessary, work closely with Commercial, Business Development, Pharma, R&D, Product Marketing, Regulatory, Software and Informatics, Assay Development, and Quality teams.

The ideal candidate has held leadership positions at clinical genomics laboratories utilizing advanced next-generation sequencing technologies (NGS). This individual has a strong background in molecular and cytogenetic methods used for hereditary disease and cancer diagnostics. These methods include NGS-based detection of single nucleotide and indel variants, mitochondrial genome variants, chromosomal and sub-chromosomal copy number variants, pharmacogenetic variants, and methylation abnormalities. Understanding of diagnostic approaches in somatic oncology are required, including karyotyping, FISH, MSI analysis, and NGS. In addition, this individual must have excellent understanding of variant classification and reporting standards and the relevance of tertiary analysis software for these purposes. The candidate must be aware of trends in professional practice in clinical molecular genetics in the United States and a wide network of connections with key opinion leaders and professional societies. 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 clinical laboratories for molecular screening and diagnostics in hereditary diseases and cancer. The candidate must have demonstrated active participation in research and publications that have contributed to advancing genomics in medicine.

Position Responsibilities:

• Actively participate in the product development process in R&D to guide specifications for Illumina’s RUO and IVD products. Work closely with Marketing, Product Marketing,

• Assay/Product Development as well as product life cycle teams to support the execution of the product launch strategy, and ensure internal and external launch readiness

• Coordinate medical affairs strategies for evidence generation and scientific communication in relation to product development and product launches across hereditary diseases and 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 who are interested in utilizing Illumina products for clinical trials or other purposes

• Support the development of scientific and medical education content and in-house training for the commercial team (sales and marketing) and others in relation to product development and product launches

• 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, collabora