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Palo Alto, California, United States
Hybrid
Clinical Study Development & Operations
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.
Play a key role in implementing the 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 and study protocols.
Manage the clinical development & clinical operations groups and affiliated CROs and investigators, including vendor selection/management/monitoring, site selection, patient enrollment and follow-up.
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).
Collaborate with Data Engineering to store, curate, and cross-reference DELFI's clinical data.
Communication, Thought Leadership & Outreach
Participate in industry stakeholder groups and consortia such as BLOODPAC or the Global Alliance for Genomics and Health.
Present to senior leadership, company-wide, and at key national scientific and clinical meetings.
Required
PhD in the physical or natural sciences, or MD. Disciplinary expertise in cancer biology strongly preferred.
8+ years' expertise leading the design & development of clinical studies for either pharmaceutical or diagnostics development, as evidenced by a 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.
6–8 years' management experience including best practices in recruiting, coaching, performance management, and career development.
Excellent 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
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.
