Delfidiagnostics4mo ago

Vice President, Clinical Development and Trial Innovation

Palo AltoFull-Timeexecutive

OtherHealthcareDevelopment

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Quick Summary

Overview

About Us Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.

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OtherHealthcareDevelopment

About Us

Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.

Delfi Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole-genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.

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.

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.

About the Role

The VP, Clinical Development and Trial Innovation provides strategic leadership across DELFI’s clinical study portfolio, working closely with executive leadership and cross-functional teams including R&D, medical, quality, and regulatory. This leader defines and shapes the comprehensive strategy for all DELFI clinical studies while executing on our key trials supporting product development, launch, and reimbursement. We seek an adaptable, rigorous, future-thinking, and decisive leader who is solidly grounded in clinical development and will champion the use of AI to innovate on clinical trial efficiency. The role requires technical expertise in clinical study design and development, oncology, and preferably diagnostics product development.

Clinical Study Design & Development

Design, 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

Establish and implement a comprehensive 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

Manage the clinical development & clinical operations groups and affiliated CROs, including vendor selection/management/monitoring, site selection, patient enrollment and follow-up, etc.

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)

AI-Enabled Trial Innovation and Product Development

Liaise with the head of R&D and the PIs of research & clinical studies sponsored by DELFI to develop sub-studies and relevant aims that advance DELFI’s R&D pipeline

Champion the use of AI to innovate on clinical trial recruitment or efficiency

Work with digital health providers in the US, EU, and Asia to streamline and accelerate trial data collection and scale the cross-referencing of longitudinal clinical and genomic data with national disease registries, health-promotion programs, and socioeconomic and environmental records

Collaborate with Data Engineering to store, curate, and cross-reference DELFI's clinical data

Communication, Thought Leadership, and Outreach

Participate in industry stakeholder groups and consortia such as BLOODPAC or the Global Alliance for Genomics and Health

Present to senior leadership, board of directors, company-wide, and at key national and international scientific & clinical meetings

PhD in the physical or natural sciences, or MD. Disciplinary expertise in cancer biology strongly preferred

10+ years’ expertise leading the design & development of clinical studies for either pharmaceutical or diagnostics development, as evidenced by 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

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

10+ years’ management experience including best practices in recruiting, coaching, performance management, and career development

Superb 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