Vice President, Clinical Solutions Product Development

Role: Vice President of Clinical Solutions Product Development leading Illumina's next-generation sequencing (NGS) clinical assay portfolio, including products for reproductive health, genetic disease, and oncology. Responsibilities: oversee end-to-end development of RUO and IVD products from concept through regulatory approval and market support, collaborate with Medical Affairs, Regulatory, Quality, Operations, and Commercial teams, and manage a senior R&D team. Partner with Product Management and Medical Affairs to align product and clinical strategies, ensure platform/software integration, and develop strategic partnerships. Ensure regulatory compliance across geographies (FDA, IVDR), manage budgets and resources, and maintain relationships with key opinion leaders. Participate in customer interactions and scientific conferences to uphold technical leadership. Requirements: PhD or MD in life sciences strongly preferred, 20+ years of related experience with 15+ years in leadership, experience in molecular diagnostics, clinical laboratory settings, and IVD development, with deep knowledge of regulatory pathways (US/Europe). Proven track record in clinical assay development, regulatory approval, and multidisciplinary team leadership. HighValue: molecular diagnostics, NGS, clinical assay development, regulatory compliance, leadership in high-complexity IVD and clinical labs, cross-functional collaboration. WorkSetup: Not specified; likely hybrid or on-site given senior executive nature and collaboration needs.