Associate Director/Director, Clinical Product Development

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