Vice President, Clinical Development and Trial Innovation

DELFI Diagnostics, Inc. • Palo Alto, CA

1d

About The Position

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.

Requirements

• PhD in the physical or natural sciences, or MD.
• Disciplinary expertise in cancer biology strongly preferred10+ 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

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 101-250 employees