Director, Precision Medicine and IVD Development

The Opportunity

We are seeking an experienced Director, Precision Medicine and IVD Development. This foundational role defines IVD product strategy, builds out and refines the existing precision medicine roadmap, and drives execution against that roadmap, serving as a cross-functional leader of development teams comprised of translational science, clinical, regulatory, computational biologists and R&D team members. The ideal candidate brings diagnostic industry experience and has successfully launched molecular diagnostics in both pharma partnership and direct-to-clinic models.

We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website.

We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

• Develop and own IVD product strategy across companion diagnostics and LDT products and programs, by identifying opportunities strategically aligned with company objectives, market opportunities, and the competitive landscape
• Define clinical reporting strategy of Precede Bioscience’s novel biomarkers and the validation evidence required to enable clinical reporting
• Lead and continue the maturation and improvement of the IVD product development function, defining processes, frameworks, and best practices appropriate for our stage and growth trajectory

• Partner with R&D, Translational Science and Biopharma to translate and integrate customer needs and clinical requirements into product specifications and acceptance criteria
• Partner with the Computational Biology and Product Development teams to design validation and utility studies that support product claims and reimbursement
• Collaborate with regulatory affairs to define regulatory strategy (LDT vs. FDA submission pathway) for each product

• Serve as product lead for CDx pharma partnerships, understanding drug development timelines and CDx biomarker requirements
• Define product requirements for companion diagnostics aligned with partner therapeutic programs
• Manage product-related aspects of collaboration agreements, including deliverables, milestones, and success metrics

• Conduct voice-of-customer research with oncologists, pathologists, pharmaceutical partners, and research customers to identify unmet needs and validate product concepts
• Analyze competitive landscape in cfDNA diagnostics, monitoring developments from other pioneering diagnostic companies
• Synthesize market intelligence, reimbursement trends, and clinical evidence requirements to inform product strategy
• Build relationships with key opinion leaders and clinical collaborators to guide product development

• A minimum of 10 years of experience developing NGS-based IVDs, with at least 5 years in molecular diagnostics, oncology diagnostics, or precision medicine
• Direct experience developing and launching diagnostic products through both LDT and companion diagnostic pathways
• Experience collaborating with biopharma and academic partners to develop novel biomarkers and diagnostic solutions

• Deep understanding of…