Qureos Mentor

Delfi Diagnostics

<div><div><div><b>About Us</b></div><div></div><div><br>
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 (&quot;DNA EvaLuation of Fragments for early Interception&quot;) 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&rsquo; platform relies on fragmentomics &ndash; 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&rsquo; 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.</div><div></div><div><br>
In our passionate pursuit to radically improve health outcomes, we serve humanity when we:</div><div></div><div><b><br>
Lead with Science, Anchor in Pragmatism</b>: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.<br>
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<div><b>Build With &amp; For All</b>: 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 class</div><div></div><div><b><br>
Put We over I</b>: 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.</div><div></div><div><b><br>
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 offices</b></div><div></div><div><br>
We are seeking an exceptional Vice President of Assay Research &amp; Development to lead our core scientific initiatives and drive the development of next-generation cancer in vitro diagnostics (IVDs). This role will oversee the end-to-end development of multi-omics assays, from early research through clinical validation, with a focus on NGS-based platforms and high-throughput methodologies.</div><div></div><div><br>
As the VP of Assay R&amp;D, you will be a critical member of our leadership team, responsible for defining and executing the strategic vision for all assay development activities. Reporting to the CTO, you will lead a talented team of scientists and engineers and spearhead key external collaborations, driving the discovery, development, verification, and validation of novel diagnostic assays from concept to commercialization. This role requires a strong technical background in NGS, high-throughput systems, and multi-omics, coupled with a proven track record of successful product development in an FDA-regulated environment.</div></div>
<div><div><h3 class="jobSectionHeader"><b>What you&rsquo;ll do</b></h3><ul><li><ul><li><b>
Strategic Leadership</b></li><li>
Define and execute the long-term R&amp;D strategy for IVD assay development, aligned with company objectives and market needs</li><li>
Lead cross-functional collaboration with Clinical Development, Quality/Regulatory, Software, Data Science/ML, and Medical Affairs teams</li><li>
Drive innovation in multi-omics approaches, integrating biomarker discovery and assay development across the central dogma</li><li>
Establish and maintain strategic partnerships with academic institutions, technology providers, and clinical collaborators</li><li><b>
Technical Excellence</b></li><li>
Oversee development of NGS-based cancer diagnostic assays from concept to clinical implementation</li><li>
Champion high-throughput assay development and automation strategies to support scalable operations</li><li>
Ensure robust analytical validation and clinical validation studies meet regulatory requirements for both LDT and IVD pathways</li><li>
Drive continuous improvement of existing assay performance, including sensitivity, specificity, and turnaround time</li><li><b>
Team Development &amp; Management</b></li><li>
Build and lead a world-class team of scientists, engineers, and research associates</li><li>
Foster a culture of scientific rigor, innovation, and collaborative problem-solving</li><li>
Provide mentorship and career development opportunities for team members</li><li>
Establish clear performance metrics and accountability frameworks</li><li><b>
Regulatory &amp; Quality</b></li><li>
Collaborate with Regulatory Affairs to ensure compliance with FDA, CAP, CLIA, and other relevant regulations and guidelines</li><li>
Support IVD development activities including design controls, risk management, and regulatory submissions</li><li>
Maintain highest standards for data integrity, documentation, and quality management systems</li><li>
Ensures assay development is conducted with rigorous adherence to Design Control practices, following the Quality Management System (QMS).</li><li>
Ensures thorough documentation of development processes, experimental results, and data analyses to support internal decision-making and regulatory submissions.</li><li>
Ensures robustness of assays and facilitates design transfer to other departments including, but not limited to Manufacturing, Quality Systems, Regulatory Affairs and Marketing.</li></ul></li></ul></div></div>
<div><div><h3 class="jobSectionHeader"><b>What you'll bring to DELFI</b></h3><ul><li><ul><li><b>
Required</b></li><li>
PhD in Molecular Biology, Genetics/Genomics, Biochemistry, or related field with 20+ years of experience</li><li>
Minimum 8 years in senior leadership roles in diagnostics, biotechnology, or pharmaceutical industry, exemplifying best practice in recruiting, team-building, employee performance management and career development, goal-setting, and cross-functional collaboration</li><li>
10+ years experience with NGS technologies, assay development, and multi-omics integration</li><li>
Proven track record in high-throughput assay development, LIMS, and laboratory automation as evidenced by assays released into production and/or publication record</li><li>
Deep understanding of regulatory requirements for diagnostic test development (FDA Class I/II/III, 510(k), De Novo, CDx, CAP, CLIA, NYSDPH)</li><li>
Experience with both LDT operations and IVD development pathways</li><li>
Strong publication record and demonstrated thought leadership in cancer diagnostics, genetics, genomics, or related fields</li><li>
Superb written, verbal communication, and influencing and presentation skills, including the ability to communicate complex concepts succinctly to a variety of audiences</li><li>
Decisive, proactive, and composed with a balance of high IQ and EQ</li><li><b>
Preferred Qualifications</b></li><li>
Previous experience in cancer diagnostics, precision oncology, or companion diagnostics</li><li>
Experience with liquid biopsy, ctDNA, or minimal residual disease detection</li><li>
Experience with clinical trial design and biomarker validation studies</li><li>
Six Sigma, Design of Experiment (DOE)</li></ul></li></ul></div></div>
<div><div>$275,000 - $360,000 a year</div><div>
Total 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 &amp; depth of experience, certifications &amp; relevant education, geography.</div></div>
<div><div>We 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.</div><div></div><div><b><br>
This position is not eligible for agency partnership. Resumes and outreach from staffing representatives will be declined.</b></div></div></div><div></div>

Vice President, Assay Research & Development

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Delfi Diagnostics

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Vice President, Assay Research & Development