Senior Director, Assay Development

Delfi Diagnostics

Senior Director of Assay Development leading a team in developing blood-based tests for cancer detection. Directing assay development from strategy to FDA submissions with a focus on innovation.

Posted 5/13/2026full-timePalo Alto • California • 🇺🇸 United StatesSenior💰 $275,000 - $310,000 per yearWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

flexible time-off policy
401(k) retirement plan
extremely competitive medical, dental, and vision coverage
onsite lunch 3 days a week
other wellness related offerings

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

assay developmentanalytical validationdesign verificationreagent developmentstatistical process controldesign transferquality systemsSOPsFDA regulatory submissionsmulti-marker genomic assays

Soft Skills

leadershipcommunicationrisk judgmentpragmatisminnovationaccountabilitydecisivenesscomposurecoachingperformance management

Certifications

PhDMS