Director, Precision Medicine and IVD Development

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

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

The expected salary range for this role is $200,000 - $250,000 per year. Final compensation will be based on a candidate’s qualifications, experience, and geographic location. Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.

We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!

Precede Biosciences is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.

Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions