Director, Medical Affairs

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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.

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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, collaborators, and other key opinion leaders

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• MD or MD/PhD certified by the American College of Medical Genetics and Genomics in clinical molecular genetics or laboratory genetics and genomics (LGG), or MD certified by the American Board of Pathology.
• 10+ years of direct hands-on CLIA/CAP clinical laboratory experience required in hereditary diseases and cancer screening and diagnostic testing.
• Deep experience with Illumina next-generation sequencing and bioinformatics technologies preferred.
• 8+ years of leadership experience in a clinical genomics laboratory, preferably involved in cross-functional business execution
• 5+ years experience leading teams of individuals with diverse expertise, experience, and professional backgrounds.
• Experience with regulatory aspects of clinical genomics laboratories and clear
• understanding of patient safety considerations
• Experience bridging activities of medical teams with those of commercial, legal, quality, product, and other teams.
• Excellent cross-functional leadership experience in highly matrixed setting
• Strong oral and presentation communication skills to present scientific content to national audiences
• Ability to travel at least 30% time
• Excellent inter-personal skills and ability to work with people of diverse educational and professional backgrounds

All listed requirements are deemed as essential functions to this position; however, business

#LI-REMOTE

The estimated base salary range for the Director, Medical Affairs role based in the United States of America is: $220,500 - $330,700. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants.