Director, Precision Medicine – IVD Development

Precede Biosciences

. Develop and own IVD product strategy across companion diagnostics and LDT products and programs .

Posted 9/25/2026full-timeCambridge • Massachusetts • United StatesLead💰 $200,000 - $250,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

Minimum 10 years of experience developing NGS-based IVDs
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 cancer biology, cfDNA biology, liquid biopsy technologies, and NGS-based diagnostic workflows
Knowledge of the oncology diagnostic landscape, including competitive products, clinical utility requirements, and adoption barriers
Understanding of regulatory pathways, including CLIA/CAP for LDTs, FDA approval/clearance for IVDs, and companion diagnostic regulations
Familiarity with reimbursement landscapes for molecular diagnostics, including Medicare LCD/LCA processes and private payer coverage
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
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
Advanced degree PhD and/or MD in life sciences, molecular biology, oncology, pathology, or related field (preferred qualifications)
Direct experience with cfDNA/ctDNA assays and liquid biopsy applications in oncology (preferred qualification)
Experience with both US and international IVD products (preferred qualification)

Benefits

Comp & perks

Performance bonuses
Equity participation
Comprehensive health benefits