Associate Director/Director, Clinical Product Development
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Overview
Job Description
The Associate Director/Director of Clinical Product Development will lead end-to-end development and execution of clinical-stage molecular diagnostics. This role is responsible for translating scientific innovation into clinically validated, regulatory-ready, and commercially viable products, spanning assay development, clinical evidence generation, regulatory strategy, and market access.
This position plays a critical leadership role in advancing molecular diagnostic products from LDT development through clinical validation, MolDx reimbursement, and potential IVD/CE-IVDR pathways, supporting multi-indication oncology programs.
Key Responsibilities
- Define and lead product development strategy aligned with clinical, regulatory, and commercial objectives
- Drive development of end-to-end workflows (sample-to-report), including assay, bioinformatics pipeline, and operational scalability
- Oversee development and optimization of clinical assays, including:
- Analytical performance (sensitivity, specificity, error modeling)
- Workflow scalability and automation
- Oversee clinical validation studies, ensuring generation of data packages suitable for regulatory submissions and payer evidence requirements
- Support transition from research to CLIA/CAP LDT and future IVD/kit formats
- Ensure product readiness for commercialization and operational scale
- Build and lead a high-performing clinical product development team
- Mentor team members and establish best practices for clinical product development
Requirements
Education & Experience
- PhD or equivalent in molecular biology, genetics, oncology, or related field
- 10+ years of experience in diagnostics or biotech, with strong focus on clinical product development
- Proven experience leading development of oncology diagnostics, preferably tumor tissue sequencing assays and/or ctDNA based assays for somatic mutation detection
- Experience with tumor tissue sample processing from FFPE block, H&E staining, DNA extraction to sequencing
- Deep understanding of liquid biopsy, oncology diagnostics and NGS-based assay development
- Familiarity with assay validation frameworks (CLIA/CAP, analytical validity, clinical validity, clinical utility)
- Demonstrated success in clinical validation and regulatory/reimbursement submissions
- Prior experience with MRD detection approaches is a plus
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