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DELFI Diagnostics · 2 weeks ago

Vice President, Clinical Development and Trial Innovation

Palo Alto, CA

Full-time

Hybrid

Director/Executive

10+ years exp

DELFI Diagnostics, Inc. is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages. The Vice President of Clinical Development and Trial Innovation will provide strategic leadership across DELFI’s clinical study portfolio, overseeing the design and execution of clinical studies while championing the use of AI to enhance clinical trial efficiency.

Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical

Responsibilities

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

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)

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

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

Qualification

Clinical study designOncology expertiseIVD diagnostics developmentRegulatory standards knowledgeAI in clinical trialsManagement experienceStart-up mindsetProactiveDecisiveCommunication skills

Required

PhD in the physical or natural sciences, or MD

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

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

Preferred

Disciplinary expertise in cancer biology strongly 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