Vice President, Clinical Solutions Product Development

Illumina•San Diego, CA

3d•Onsite

About The Position

The Vice President of Clinical Solutions Product Development will lead the end-to-end development of Illumina’s next generation sequencing (NGS) clinical assay product portfolio, translating scientific innovation into clinically and commercially viable products for use in global markets. This executive role is responsible for strategy, execution, and cross functional leadership across product development teams, from early concept through regulatory approval and commercialization readiness, as well as on market sustainment. The clinical markets are the one of the largest growth segments at Illumina and include reproductive health, genetic disease and oncology. Position Summary: Responsible for overseeing RUO and IVD product development teams as well as on market- support for clinical assay and next-generation sequencing library preparation products. Works closely with parters across the Clinical Solutions Leadership, including Medical Affairs, Regulatory, Quality, Operations and Commercial to deliver new products and execute on our long term strategy. Partners with R&D groups, Medical Affairs, and Product Management on future strategy and clinical needs in developing products within Oncology, Reproductive Health and Genetic Disease testing areas. Partners closely with Product Management and Medical Affairs to translate technical and clinical roadmaps into product roadmaps, working together to prioritize and execute on the portfolio. Partners with R&D teams for platforms and software to ensure seamless integration of clinical assays into Illumina’s platforms and software systems to create full end-to-end solutions. Manages a team of directors and/or high-level individual contributors who manage a larger R&D organization. Works through managers and their teams to develop a highly engaged and high performing team. Works with business development teams on developing and executing on strategic partnerships. Regularly participates in customer interactions alongside R&D groups and Medical Affairs. Provides direct consultation for clinical customers on on-market products in partnership with Medical Affairs Ensures compliance with regulatory and quality standards for IVD products for different geography regulatory standards (FDA, IVDR, etc.) Manages budgets, timelines, and resource allocation. Develops and maintains relationships with key opinion leaders and attends and presents at scientific meetings and national and international congresses to ensure Illumina’s continued technical and scientific leadership

Requirements

Bachelor’s degree and a minimum of 20 years of related experience.
15+ years of Leadership experience.
Deep understanding of IVD development including regulatory processes in US and European markets.
Proven track record advancing assays through clinical development and toward regulatory approval.
Deep understanding of development of assays and library prep for next generation sequencing.
Strong strategic thinking, executive communication, and decision-making skills.
Experience building and leading multidisciplinary teams.

Nice To Haves

Advanced degree in life sciences (PhD or MD) very strongly preferred.
P&L management experience is preferred.
Experience in developing molecular diagnostics technology and in high-complexity clinical laboratory settings is preferred.

Responsibilities

Lead the end-to-end development of Illumina’s next generation sequencing (NGS) clinical assay product portfolio.
Translate scientific innovation into clinically and commercially viable products for use in global markets.
Oversee RUO and IVD product development teams as well as on market- support for clinical assay and next-generation sequencing library preparation products.
Partner with R&D groups, Medical Affairs, and Product Management on future strategy and clinical needs in developing products within Oncology, Reproductive Health and Genetic Disease testing areas.
Translate technical and clinical roadmaps into product roadmaps, working together to prioritize and execute on the portfolio.
Ensure seamless integration of clinical assays into Illumina’s platforms and software systems to create full end-to-end solutions.
Manage a team of directors and/or high-level individual contributors who manage a larger R&D organization.
Develop a highly engaged and high performing team.
Develop and execute on strategic partnerships with business development teams.
Participate in customer interactions alongside R&D groups and Medical Affairs.
Provide direct consultation for clinical customers on on-market products in partnership with Medical Affairs.
Ensure compliance with regulatory and quality standards for IVD products for different geography regulatory standards (FDA, IVDR, etc.).
Manage budgets, timelines, and resource allocation.
Develop and maintain relationships with key opinion leaders.
Attend and present at scientific meetings and national and international congresses to ensure Illumina’s continued technical and scientific leadership.