Principal Clinical Trial Manager - Clinical Operations

February 21

Apply Now

Receive Emails with Similar Jobs

Delfi Diagnostics

WebsiteLinkedInAll Job Openings

Delfi Diagnostics is a company dedicated to saving lives through early cancer detection using their innovative fragmentomics technology. Delfi has pioneered breakthroughs in machine learning and fragmentomics by analyzing cell-free DNA fragments from simple liquid biopsy blood samples to support early-stage cancer detection. Their scalable approach allows them to quickly scan millions of data points to identify previously unrecognized cancer-associated DNA fragments. Delfi Diagnostics collaborates with leading cancer biology, bioinformatics, and machine learning experts to advance their technology. The company has initiated a large-scale clinical trial, CASCADE-LUNG, to validate the effectiveness of its approach.

11 - 50 employees

Founded 2018

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $225M Series B on 2022-07

📋 Description

• 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. • Build With & For All: We embrace diverse backgrounds to innovate and achieve together. • Put We over I: We are a home for high-performing people.

🎯 Requirements

• Bachelor’s degree (or higher) in science or health-related discipline • 10 years of direct clinical operations experience in a sponsor (Pharmaceutical or Biotech) and bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years experience; or equivalent experience. • Industry experience within in vitro diagnostics (IVD) required • Demonstrated experience in participating in the development, implementation, management, and completion of large, regulated clinical trials. • Ability to assist in preparation of a clinical development plan, clinical trial design, protocol writing, and essential documents. • Strong understanding of GCPs, ICH, and knowledge of regulatory requirements • Familiarity with ISO 20916 and/or 14155 standards preferred • Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization. • Ability and willingness to travel ~10-15% of the time. • Oncology experience in clinical research • Clinical experience (oncology, cancer center, inpatient or outpatient or physician office setting) a plus

🏖️ Benefits

• 100% paid medical, dental and vision premiums for employees and dependents • 4 months fully paid parental leave • Flexible Time Off • 5 day winter break in December • A meaningful mission and strong company culture