Director, Medical Affairs (Pathology/Oncology)

Illumina • San Diego, CA

20d

About The Position

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 molecular pathology with a strong background in cancer diagnostics, biomarkers, cancer therapeutics and extensive experience in developing genomic tests for Oncology. This position is within Illumina’s Medical Affairs organization. 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 cancer and hereditary diseases. 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 in clinical genomics laboratories utilizing advanced next-generation sequencing technologies (NGS). This individual has a strong background in the development and application of molecular an conventional diagnostics methods used for cancer screening and diagnostics as well as hereditary diseases. Understanding of diagnostic approaches in genetic disease testing 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 molecular diagnostics in the United States and beyond as well as 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 cancer and hereditary diseases. The candidate must have demonstrated active participation in research and publications that have contributed to advancing genomics in medicine This role will also provide direct medical affairs support of pharma partnerships as well as lead the development and execution of an external facing molecular diagnostic tumor board

Requirements

• MD or MD/PhD certified by the American Board of Pathology.
• 10+ years of direct hands-on CLIA/CAP clinical laboratory experience required in cancer screening and diagnostic testing.
• 8+ years of leadership experience in a molecular pathology/clinical genomics laboratory, preferably involved in cross-functional business execution
• 5+ years of experience in development of molecular diagnostics methods used for cancer screening and diagnostics
• Deep experience with Illumina next-generation sequencing and bioinformatics technologies preferred.
• 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
• Typically requires a Bachelor’s degree and a minimum of 18 years of related experience, with 10+ years of Management experience
• All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

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 cancer screening and diagnostics and hereditary diseases
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree