Director, Medical Affairs

Job Description:

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, collaborators, and other key opinion leaders

Position Requirements

• MD or MD/PhD certified by the American Board of Pathology and American College of Medical Genetics and Genomics in molecular genetic pathology (MGP).
• 10+ years of direct hands-on CLIA/CAP clinical laboratory experience required in cancer screening and diagnostic testing.
• Deep experience with Illumina next-generation sequencing and bioinformatics technologies preferred.
• 10+ years of senior leadership experience in a clinical genomics laboratory, preferably involved in cross-functional business execution
• 10+ years experience leading teams of individuals with diverse expertise, experience, and professional backgrounds.
• Experience bridging activities of medical teams with those of commercial, regulatory, legal, quality, product, and other teams.
• Demonstrated extensive research and publications output in prominent scientific journals as first or senior author.
• Experience interacting with patient advocacy groups, government policymaking bodies, and federal regulatory bodies.
• Excellent cross-functional leadership experience in highly matrixed setting.
• Strong oral and presentation communication skills to present Illumina research to national audiences.
• Ability to travel at least 30%.
• Excellent inter-personal skills and ability to work with people of diverse educational and professional backgrounds.

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.