About the roleAs 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.
What you'll do- 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
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What you'll bringRequired- 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
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Preffered - 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
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$275,000 - $310,000 a year
Actual base pay will consider experience, skillset, education, and geography.
This role may be eligible for other forms of compensation, including an annual bonus and a new hire equity grant, subject to the terms of the applicable plans and Company discretion. All employees are also eligible for DELFI's comprehensive and competitive benefits package, including but not limited to: a flexible time-off policy; a 401(k) retirement plan; an extremely competitive medical, dental, and vision coverage; onsite lunch 3 days a week; and other wellness related offerings.
