Director, Precision Medicine and IVD Development

Job description

**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. **About Us** 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. ### What You'll Do **Strategic Product Leadership** - 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 **Cross-Functional Product Development** - 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 **Companion Diagnostic Partnerships** - 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 **Market & Customer Insights** - 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 ### Who You Are **Experience** - 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 **Technical & Domain Knowledge** - Deep understanding of cancer biology, cfDNA biology, liquid biopsy technologies, and NGS-based diagnostic workflows - Knowledge of oncology diagnostic landscape, including competitive products, clinical utility requirements, and adoption barriers - Understanding of regulatory pathways (CLIA/CAP for LDTs, FDA approval/clearance for IVDs, companion diagnostic regulations) - Familiarity with reimbursement landscape for molecular diagnostics, including Medicare LCD/LCA processes and private payer coverage **Skills & Competencies** - Strong strategic thinking with ability to balance long-term vision with near-term execution - Excellent cross-functional leadership and influence without authority - Outstanding communication skills with ability to present to diverse audiences, from technical teams to executive leadership - Data-driven decision making with proficiency in analyzing market data, customer research, and product metrics - Experience managing complex stakeholder relationships including pharma partners, clinicians, and internal teams - Entrepreneurial mindset with comfort operating in ambiguity and resource-constrained environments **Education & preferred qualifications** - Advanced degree PhD and/or MD in life sciences, molecular biology, oncology, pathology or related field - Direct experience with cfDNA/ctDNA assays and liquid biopsy applications in oncology - Experience with both US and international IVD products