Associate Director/Director, Clinical Product Development

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
• 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