Senior Director, Assay Development

DELFI Diagnostics•Palo Alto, CA

2d•Onsite

About The Position

DELFI Diagnostics, Inc. (DELFI Diagnostics) is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI ("DNA EvaLuation of Fragments for early Interception") platform is built to address the highest-burden health challenges. DELFI Diagnostics prioritizes solutions that have the potential to save lives on a global scale, including for historically underserved populations. DELFI Diagnostics’ platform relies on fragmentomics – the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments. FirstLook Lung, for individuals eligible for lung cancer screening, is DELFI Diagnostics’ first laboratory-developed screening test and can be part of routine blood work. FirstLook Lung uses millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. As Senior Director of Assay Development, you will own all development activities across DELFI’s NGS-based cancer screening portfolio — driving the transition of innovative assays into verified, validated, and manufacturable IVD products. Reporting to the CTO, you will lead a team of scientists and functional leaders and serve as a key voice on product strategy across R&D, Quality, Regulatory, and Manufacturing. This role demands hands-on scientific judgment to know when and where to take calculated risks — and when not to — leading with science while anchoring every decision in pragmatism to keep programs moving against ambitious timelines without compromising quality or integrity.

Requirements

PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline
12+ years in IVD and/or LDT assay development in regulated environments
Hands-on expertise in AV and design verification of multi-marker genomic or ‘omic-based assays, with direct experience contributing to FDA regulatory submissions
Deep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR
Proven track record designing scalable processes, SOPs, quality systems, and operational infrastructure in regulated IVD environments
Demonstrated ownership of late-stage development programs through design transfer and manufacturing scale-up
Ability to lead with science while anchoring in pragmatism — applying hands-on expertise to make sound risk judgments that keep programs on ambitious timelines without sacrificing rigor or compliance
8+ years’ management experience including best practices in recruiting, coaching, performance management, and career development
Superb communication skills including mastery in written & oral presentations, large- and small-group forums
Start-up mindset: passionate, innovative, accountable, able to rapidly prioritize and triage, biased to action
Proactive, decisive, and composed with a balance of high IQ & EQ

Nice To Haves

Direct leadership of FDA PMA submissions
Background in reagent development, critical reagent qualification, and SPC in manufacturing environments
Experience in high-growth or scaling biotech/diagnostics companies; track record of multiple launched LDT/IVD products

Responsibilities

Own end-to-end assay development strategy across all LDT and IVD programs — from study design and execution through protocol approval, analytical validation, regulatory documentation, and FDA PMA submissions
Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards (21 CFR Part 820, ISO 13485, ISO 14971, IVDR)
Contribute to and/or lead Formal Design Reviews at key milestones; partner with Systems Engineering to ensure product requirements are fully addressed through design verification
Oversee reagent development and qualification, automated process scale-up, and statistical process control (SPC) for lab production environments
Lead design transfer activities across programs, ensuring robust handoffs to manufacturing and sustained assay performance at commercial scale
Report directly to the CTO; lead a team of scientists and functional leaders across assay development, validation, and manufacturing readiness
Design and own the operational infrastructure for the function — scalable processes, SOPs, design control frameworks, and traceability systems aligned to 21 CFR Part 820 and ISO 13485
Apply hands-on scientific judgment to make deliberate risk decisions — knowing where to push for speed and where standards are non-negotiable — keeping programs moving against ambitious timelines without compromising quality or integrity
Represent Assay Development at the executive level; align with the CTO, VP of Regulatory & Quality, and other senior leaders on portfolio priorities and product strategy