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 officesIn the Medical Director/Senior Medical Director (Clinical Development & Medical Affairs) role you will work collaboratively with DELFI clinical development, medical statistics, medical affairs, reimbursement and market access, and externally with clinical experts, guideline organizations, patient advocacy groups, and key opinion leaders to establish understanding of DELFI clinical research and technology. You will also support the generation of product related evidence through review and support of external investigator led studies, and on developing and implementing Real World Evidence generating registries of DELFI technologies in clinical use, focused on enriching the ability of clinicians, payers, and regulatory authorities in the US and abroad. You will play key leadership and participatory roles in DELFI’s own clinical development program including interacting with study sites and collaborating on protocols.*Medical degree (MD, DO or equivalent) with 5+ years of clinical practice is required for this role*What you’ll doServe as expert clinical contributor within the company regarding clinical use and enhancements of current and potential DELFI technologiesContribute to the protocol, monitoring plan, and CRF development for DELFI clinical trials by working collaboratively with Clinical Operations, Clinical Data Management, Statistical Science, Medical Communications, and Regulatory groups at DELFI. Regularly engage expert advisors on matters of study design and endpointsEnsure execution of clinical trials in support of DELFI’s clinical evidence strategy.Provide project team training on disease and/or therapeutic areasWhat you’ll have accomplished 12 months from nowExecuted on DELFI clinical studies, acting as medical monitor, facilitating execution and data interpretationLead the preparation of clinical study reports for on-going studies, provide medical input for publications and support Regulatory strategy, including submissionsProvide internal education and clinical insight to help refine DELFI product use applicationsClosely monitored and ensured clinical compliance and high scientific standards in ongoing trialsFostered relationships with KOLs in US and internationally for the assessment of DELFI technology, evidence evaluation and clinical guidelines, including relevant clinically focused advocacy organizations.Supported the launch of at least one investigator initiated studyPresented at several relevant scientific conferences and medical meetingsProvided evidentiary structure and helped design and prepare registry of DELFI technology in real world useProvided registry guidance for new productsRequiredMedical degree (MD, DO or equivalent) with 5+ years of clinical practicePrior clinical trial implementation experience in Pharma or Medical DevicesThorough understanding of medical practice and diagnosis related to pulmonology, cancer care or screeningKnowledge of regulatory and GCP elements of clinical trialsExcellent organization, communication, presentation, critical thinking, and interpersonal skillsAbility to influence and build and foster relationships horizontally and vertically across the organizationAbility to communicate with senior leadership, clinicians, and regulatory authorities.Excellent writing and presentation skills required.Availability for up to 25% business travelPreferredPrior experience in vitro diagnostic diagnostics developmentAn advanced degree in public policy or public healthMolecular diagnostics, genetics, or related scientific field backgroundWe 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. #J-18808-Ljbffr