Senior Director, Assay Development

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    "region": "CA",
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{
  "lists": [
    {
      "text": "About the role",
      "content": "<p>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&amp;D, Quality, Regulatory, and Manufacturing.</p>\n<p>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.</p>\n<p>This role requires 4 days in the Palo Alto office.&nbsp;</p>"
    },
    {
      "text": "What you'll do ",
      "content": "<div>\n\n<li>\n<p>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</p>\n</li>\n<li>\n<p>Establish and enforce compliant analytical performance claims aligned to CLIA, FDA, and international IVD standards (21 CFR Part 820, ISO 13485, ISO 14971, IVDR)</p>\n</li>\n<li>\n<p>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</p>\n</li>\n<li>\n<p>Oversee reagent development and qualification, automated process scale-up, and statistical process control (SPC) for lab production environments</p>\n</li>\n<li>\n<p>Lead design transfer activities across programs, ensuring robust handoffs to manufacturing and sustained assay performance at commercial scale</p>\n</li>\n<li>\n<p>Report directly to the CTO; lead a team of scientists and functional leaders across assay development, validation, and manufacturing readiness</p>\n</li>\n<li>\n<p>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</p>\n</li>\n<li>\n<p>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</p>\n</li>\n<li>\n<p>Represent Assay Development at the executive level; align with the CTO, VP of Regulatory &amp; Quality, and other senior leaders on portfolio priorities and product strategy</p>\n</li>\n\n</div>"
    },
    {
      "text": "What you'll bring",
      "content": "<p><strong>Required</strong></p>\n\n<li>\n<p>PhD or MS in Molecular Biology, Biochemistry, Biomedical Engineering, Genomics, or a related discipline</p>\n</li>\n<li>\n<p>12+ years in IVD and/or LDT assay development in regulated environments</p>\n</li>\n<li>\n<p>Hands-on expertise in AV and design verification of multi-marker genomic or ‘omic-based assays, with direct experience contributing to FDA regulatory submissions</p>\n</li>\n<li>\n<p>Deep knowledge of IVD regulatory frameworks: FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IVDR</p>\n</li>\n<li>\n<p>Proven track record designing scalable processes, SOPs, quality systems, and operational infrastructure in regulated IVD environments</p>\n</li>\n<li>\n<p>Demonstrated ownership of late-stage development programs through design transfer and manufacturing scale-up</p>\n</li>\n<li>\n<p>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</p>\n</li>\n<li>\n<p>8+ years’ management experience including best practices in recruiting, coaching, performance management, and career development</p>\n</li>\n<li>\n<p>Superb communication skills including mastery in written &amp; oral presentations, large- and small-group forums</p>\n</li>\n<li>\n<p>Start-up mindset: passionate, innovative, accountable, able to rapidly prioritize and triage, biased to action</p>\n</li>\n<li>\n<p>Proactive, decisive, and composed with a balance of high IQ &amp; EQ</p>\n</li>\n\n<p><strong>Preffered&nbsp;</strong></p>\n\n<li style=\"list-style-type: none;\">\n\n</li><li>\n<p>Direct leadership of FDA PMA submissions</p>\n</li>\n<li>\n<p>Background in reagent development, critical reagent qualification, and SPC in manufacturing environments</p>\n</li>\n<li>\n<p>Experience in high-growth or scaling biotech/diagnostics companies; track record of multiple launched LDT/IVD products</p>\n</li>\n\n\n"
    }
  ],
  "country": "US",
  "createdAt": 1778704388200,
  "updatedAt": null,
  "categories": {
    "team": "Research & Development",
    "location": "Palo Alto, CA",
    "commitment": "Full-Time",
    "department": "Assay Research & Development",
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      "Palo Alto, CA"
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