Senior Director, Clinical Development

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.