Precede Biosciences

Director

• Develop and own IVD product strategy across companion diagnostics and LDT products and programs
• Identify opportunities aligned with company objectives, market opportunities, and competitive landscape
• Define clinical reporting strategy for novel biomarkers and validation evidence required for clinical reporting
• Lead and mature the IVD product development function by defining processes, frameworks, and best practices
• Partner with R&D, Translational Science, and Biopharma to translate customer needs and clinical requirements into product specifications and acceptance criteria
• Partner with Computational Biology and Product Development teams to design validation and utility studies supporting product claims and reimbursement
• Collaborate with regulatory affairs to define regulatory strategy for each product
• Serve as product lead for companion diagnostic pharmaceutical partnerships
• Define product requirements for companion diagnostics aligned with partner therapeutic programs
• Manage product-related collaboration agreement aspects, including deliverables, milestones, and success metrics
• Conduct voice-of-customer research with oncologists, pathologists, pharmaceutical partners, and research customers
• Analyze the competitive landscape in cfDNA diagnostics
• 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
• Drive execution of the precision medicine roadmap as a cross-functional leader of translational science, clinical, regulatory, computational biology, and R&D teams

Director, Precision Medicine – IVD Development