# Associate Director/Director, Clinical Product Development

**Company:** [AccuScan Sciences](http://jobs.workable.com/companies/trHQ5NyGdsqyThXBeGhJQp.md)
**Location:** Milpitas, United States
**Workplace:** on site
**Employment type:** Full-time

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## 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