The Opportunity:

Universal DX is seeking an experienced Director, IVD Assay Development to join our growing product development team working on the development and commercialization of Next Generation Sequencing (NGS) assays/products for early cancer detection. Reporting to the VP of Product Development, this role will work cross-functionally in the planning, design, and execution of development and analytical validation studies to support the Premarket Approval (PMA) application of Universal DX’s screening test for colorectal cancer. Additionally, this role will work with external and internal stakeholders for regulatory approval of the blood collection device used for the colorectal cancer screening test.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancer. As part of the team, you will be in a Company that aims to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

· Function as a technical SME in the design and execution of Development studies focused on characterizing the performance of Universal DX’s colorectal cancer test.

· Technical lead for Analytical Validation (AV) of Universal DX’s screening test for colorectal cancer.

· Develop and execute AV studies to support the Premarket Approval (PMA) application of Universal DX’s screening test for colorectal cancer.

· Provide leadership and technical expertise in experimental design, execution, and data analysis following applicable CLSI guidelines.

· Engage in interactions and negotiations with the FDA for AV study designs through pre-submissions and face-to-face meetings.

· Assist with regulatory and quality guidance for experimental and validation study design.

· Provide expert leadership in troubleshooting and assay optimization.

· Develop and deliver scientific presentations and participate in project teams.

· Manage and supervise people, conduct performance evaluations, and offer mentorship to junior members on the team.

· Author development reports, SOPs, and technical documents to support regulatory submissions.

· Provide input for annual budget and timeline planning.

· Align with department and corporate goals.

· Review and approve study deviation investigations, change control, and CAPA.

· Ability to travel 10% of working time away from work location, may include overnight/weekend travel

Qualifications:

· Ph.D/MS/BS in Molecular Biology/Biochemistry/Genetics or related field.

· Experience in a regulated environment and prior experience in the design and execution of Analytical Validation (AV) studies to support the PMA application of a liquid biopsy test is a must.

· Experience in negotiations with the FDA for AV study designs through pre-submissions and face-to-face meetings is a must.

· Strong understanding of product development process, quality standards, regulatory compliance, as well as risk assessment and mitigation in product development.

· Hands-on experience with NGS-based molecular assay development and in-depth knowledge of industry standards (including CLSI guidelines) related to NGS assays is a strong plus.

· 10+ years experience managing R&D teams and working cross-functionally in the development and commercialization of clinical diagnostics. Proven leadership in building and growing technical teams.

· Excellent leadership, communication, and interpersonal skills, with a demonstrated ability to collaborate with and influence cross-functional teams and stakeholders.

· Data driven mindset with strong analytical and strategic thinking skills. A proactive and strategic thinker with strong decision-making skills.

· Highly self-motivated and able to independently and effectively drive for results working in a dynamic environment with a sense of urgency and aggressive timelines. Strong organizational skills and ability to adapt to shifting priorities.