--- title: 'Senior Director, Clinical Development at DELFI Diagnostics, Inc.' canonical: 'https://feeny.ai/job/senior-director-clinical-development-delfi-diagnostics-inc-palo-alto-06vxbzpnzjqq' type: 'job' last_seen: '2026-09-12' --- # Senior Director, Clinical Development at DELFI Diagnostics, Inc. - **Company:** DELFI Diagnostics, Inc. - **Location:** Palo Alto, CA - **Compensation:** $260k–$320k - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-06-10 - **Last confirmed live:** 2026-09-12 - **Apply:** https://jobs.lever.co/delfidiagnostics/dc813a57-fd7c-42e1-9d1b-63502039ef14 ## Job description ## About Us 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 ("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 class Put 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 ## About this Role The Sr. Director, Clinical Development provides leadership across DELFI's clinical study portfolio, working closely with senior leadership and cross-functional teams including R&D, medical, quality, and regulatory. This leader helps to direct the comprehensive strategy for all DELFI clinical studies and to execute on our key trials supporting product development, launch, and reimbursement. We seek an adaptable, rigorous, and collaborative leader who is solidly grounded in clinical development. The role requires technical expertise in clinical study development and operations, oncology, and preferably diagnostics product development. ## What You'll Do Clinical Study Development & Operations - Develop and execute clinical studies that generate robust evidence for DELFI's current and future pipeline of product claims, including studies that establish clinical validity and clinical utility. - Advance DELFI's development of diagnostic products for cancer, with the detection of lung cancer in USPSTF-eligible individuals as the first indication. - Play a key role in implementing the five-year clinical development strategy based on the latest clinical science, evidence gaps, and unmet needs in cancer diagnostics. - Partner with R&D Biostatistics to design case-control and prospective clinical studies, and to analyze those studies in accordance with statistical analysis plans and study protocols. - Manage the clinical development & clinical operations groups and affiliated CROs and investigators, including vendor selection/management/monitoring, site selection, patient enrollment and follow-up. - Develop and manage clinical trial timelines, budget, and risks in accordance with overall product development processes and plans. Regulatory & Evidence Management - Interact with FDA on submissions for IVD product approval, including face-to-face/virtual meetings and written presubmissions in coordination with Regulatory Affairs. - Author relevant sections of IVD documents pertaining to clinical development activities, design controls, requirements, etc. - Work closely with Medical Affairs to identify evidence gaps and generate real-world data for DELFI's product(s). - Collaborate with Data Engineering to store, curate, and cross-reference DELFI's clinical data. Communication, Thought Leadership & Outreach - Participate in industry stakeholder groups and consortia such as BLOODPAC or the Global Alliance for Genomics and Health. - Present to senior leadership, company-wide, and at key national scientific and clinical meetings. ## What You'll Bring Required - PhD in the physical or natural sciences, or MD. Disciplinary expertise in cancer biology strongly preferred. - 8+ years' expertise leading the design & development of clinical studies for either pharmaceutical or diagnostics development, as evidenced by a strong publication record or successful product releases. - 3–5 years' experience in IVD diagnostics development. - Knowledge of relevant clinical & regulatory standards such as ICH E6(R3) GCP, ISO 14155, ISO 13485, 21 CFR Part 820. - 6–8 years' management experience including best practices in recruiting, coaching, performance management, and career development. - Excellent 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. ## Preferred - Familiarity with cutting-edge AI approaches in clinical trials (NLP or LLM for EHRs, digital twins, digital pathology) as well as international data standards such as FAIR principles, FHIR-OMOP, or Common Data Models. ## About DELFI Diagnostics, Inc. ## Company Overview - **One-liner**: DELFI Diagnostics is a precision oncology company that uses AI and whole-genome sequencing to analyze DNA fragmentation patterns in blood for early cancer detection. - **Entity Type**: Private (Late-Stage) - **Headquarters**: Palo Alto, California, USA - **Founded**: 2019 - **Founders**: Victor Velculescu, MD, PhD (and colleagues at Johns Hopkins University) ## Core Business - Primary industry: Precision Oncology / Liquid Biopsy / Healthcare Diagnostics - Target customers: B2B (Health systems, primary care providers, pulmonologists, lung screening programs) and B2B for research (Pharmaceutical companies) - Mission: "Make cancer less deadly through widely accessible early detection" ## Products & Services - **[FirstLook™ Lung](https://delfidiagnostics.com/)**: A blood-based, AI-powered laboratory-developed test (LDT) for lung cancer screening. Designed for adults eligible under USPSTF guidelines, it uses whole-genome sequencing and machine learning to analyze cell-free DNA fragmentation patterns. It boasts a 99.8% Negative Predictive Value and is intended to be a noninvasive first step before low-dose CT (LDCT) scans. Became commercially available in October 2023. - **[DELFI-TF Treatment Monitoring](https://delfidiagnostics.com/)**: A research service for pharmaceutical companies conducting Phase 1-2 clinical trials. It provides non-invasive, real-time treatment response assessment using cell-free DNA fragmentomes, offering short turnaround times and a low-cost solution. ## Market Standing - **Valuation**: Not publicly disclosed - **Key Metric**: Total Funding of **over $325 million** - **Notable Investors/Partners**: DFJ Growth, Eli Lilly and Company, Merck Global Health Innovation Fund (equity investment announced June 2024), OrbiMed, Point72, T. Rowe Price. - **Growth Signals**: - The FirstLook Lung test is commercially available, marking a major milestone from R&D to clinical deployment. - Completed three major clinical trials (L101 validation study, CASCADE-LUNG/L201 prospective cohort study, L301/FIRSTLUNG randomized controlled trial). - Has a strong intellectual property foundation, with its core technology first published in *Nature* in 2019. - Strategic equity investment from Merck (2024) signals pharma validation and potential for partnership. ## Competitive Advantages - **Proprietary Fragmentomics Platform**: Their AI-driven computational platform analyzes genome-wide patterns of cell-free DNA fragmentation, capturing signals that conventional mutation-based liquid biopsies often miss. This provides a broader, more sensitive view of cancer biology. - **Strong Clinical Validation**: The technology is backed by peer-reviewed publications in top journals (*Nature*, *Cancer Discovery*) and multiple registered clinical trials (NCT04825834, NCT05306288, NCT06145750). - **High Clinical Utility**: The test's 99.8% Negative Predictive Value provides high confidence to rule out lung cancer, which is a powerful tool for clinicians managing screening decisions. - **Focus on Accessibility**: Designed for large-scale health system deployment with EHR integration, provider support, and a low-cost structure to make screening widely available. ## Strategic Focus - **Market Expansion**: Driving commercial adoption of FirstLook Lung within health systems, primary care, and lung screening programs across the US. - **Clinical Evidence Generation**: Continuing to generate robust clinical data through trials like CASCADE-LUNG to further validate the technology's performance and clinical utility. - **Pharma Partnerships**: Expanding the DELFI-TF treatment monitoring service to partner with more pharmaceutical companies for drug development. - **Product Pipeline**: Likely developing additional screening tests for other cancer types using the same fragmentomics platform. ## Why Work Here - **High-Impact Mission**: The company is singularly focused on "making cancer less deadly," offering employees a direct role in a potentially transformative technology. - **Culture & Values**: DELFI emphasizes three core values guiding all interactions and decisions. They actively seek to build a diverse, inclusive, and healthy workplace so employees can do their best work. - **Hybrid/Remote Flexibility**: DELFI supports hybrid and remote work options for most positions, with labs and offices in Palo Alto, CA, and Baltimore, MD. Employees receive a one-time $400 home office subsidy. - **Comprehensive Compensation**: Offers a competitive base salary, target bonus plan, and an equity program so everyone has a stake and feels ownership. - **Generous Benefits**: - Non-accrual time off (flexible PTO) and a 5-day winter break. - DELFI pays 100% of the medical premium for employee and family. - 16 weeks of paid parental leave. - 401(k) and annual merit cycle. - **Learning & Growth**: Wide-ranging learning and development programs to help employees continue to develop their skills. - **Team & Leadership**: A dynamic, passionate group of executive leaders, clinical and data scientists, engineers, and commercial team members, led by experienced experts from relevant fields. ## Sources 1. [delfidiagnostics.com](https://delfidiagnostics.com/) 2. [delfidiagnostics.com/about-us/](https://delfidiagnostics.com/about-us/) 3. [delfidiagnostics.com/about-us/careers/](https://delfidiagnostics.com/about-us/careers/) 4. [jobs.lever.co/delfidiagnostics](https://jobs.lever.co/delfidiagnostics) 5. 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