Director, Assay Development

Job title:

Director, Assay Development

Company

DELFI Diagnostics, Inc.

Job description

About UsDELFI 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.In our passionate pursuit to radically improve health outcomes, we serve humanity when we:Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product – we aim to disrupt the path of cancer for all – no matter geography or socioeconomic classPut We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us–win. We show up with empathy, humility, and integrity at every step of the journey.DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto CA or Baltimore MD officesAs the Director of Assay Development, you will build and develop collaborative teams across our organization while driving forward our innovative lung cancer screening product. In this role, you’ll leverage your technical expertise to guide multidisciplinary teams through the development lifecycle, fostering an environment where creative problem-solving and rigorous science thrive together. Your ability to communicate complex concepts, inspire your team members, and build bridges between departments will be just as valuable as your scientific knowledge. \nWhat you’ll do

• Lead the strategic design and development of LDT and IVD diagnostic tests for our cancer screening platform
• Build and manage high-performance technical teams to successfully develop and launch products under formal IVD design controls
• Drive the development of automated processes that are scalable for production environments
• Oversee cross-functional collaboration between R&D, clinical, regulatory, and manufacturing teams
• Ensure compliance with regulatory requirements including CAP/CLIA and FDA IVD standards
• Contribute to innovation through development of novel assay technologies and approaches
• Present complex technical concepts to diverse stakeholders and influence strategic decisions
• Optimize assay performance through critical parameter management and statistical process control

What you’ll bring to DELFI

• PhD in Molecular Biology, Biochemistry, Chemistry, or a similar discipline
• 8+ years of professional assay development experience, with specific experience designing and developing LDT and IVD diagnostic tests
• Proficiency in a broad range of laboratory techniques for molecular diagnostics, including immunoassays, protein biochemistry, molecular biology, proteomics, genomics, and other ‘omics
• 6+ years of experience managing technical teams to product launch in a cross-functional environment under formal design controls
• Experience developing automated processes scalable for production environments (IVD preferred)
• Strategic and tactical leadership capabilities in building high-performance, results-driven teams
• Experience working in regulated environments (CAP/CLIA and IVD)
• Excellent written and verbal communication skills, with ability to clearly convey complex concepts
• Evidence of innovation and personal accomplishment through patents, publications, and launched LDT/IVD products
• Ability to work on-site at our Palo Alto laboratory five days a week and travel to the Baltimore office periodically

Preferred

• Background in next generation sequencing technologies, blood tests, and cancer biology
• Familiarity with databases, bioinformatic analysis, and general principles of machine learning algorithms
• Experience with formal product development methodologies such as DOE, Six Sigma, statistical process control, lean.
• Success building product development processes and launching products in a fast-paced startup environment

\n$210,000 – $240,000 a yearTotal Compensation at DELFI is a combination of salary, bonus, equity, and benefits. Actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skillset, years & depth of experience, certifications & relevant education, geography. \nWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.

Expected salary

$210000 – 240000 per year

Location

Palo Alto, CA

Job date

Mon, 17 Mar 2025 08:55:41 GMT

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