Senior Director, Clinical Development

DELFI Diagnostics, Inc. is developing next‑generation, blood‑based tests that detect cancer using advanced machine‑learning on whole‑genome sequencing data. The company’s platform, DNA Eva Luation of Fragments for early Interception (DELFI), uses fragmentomics to identify cancer cells from cell‑free DNA. First Look Lung is a laboratory‑developed screening test for individuals eligible for lung cancer screening.

The Sr. Director, Clinical Development provides leadership across DELFI's clinical study portfolio, working closely with senior leadership and cross‑functional teams in R&D, medical, quality, and regulatory. The role directs strategy for all clinical studies and executes key trials supporting product development, launch, and reimbursement.

Clinical Study Development & Operations

• Develop and execute studies that generate robust evidence for DELFI’s current and future pipeline, including clinical validity and utility.
• Advance diagnostic products for cancer, starting with lung cancer detection in USPSTF‑eligible individuals.
• Implement the five‑year clinical development strategy based on the latest scientific evidence and unmet needs.
• Partner with R&D Biostatistics to design and analyze case‑control and prospective studies in accordance with statistical analysis plans.
• Manage the clinical development, operations groups, affiliated CROs, and investigators; oversee vendor selection, site selection, patient enrollment, follow‑up, and monitoring.
• Develop and manage trial timelines, budgets, and risks aligned with product development processes.

Regulatory & Evidence Management

• Interact with FDA on IVD product submissions, including meetings and written presubmissions.
• Author relevant sections of IVD documents related to clinical development, design controls, and requirements.
• Work with Medical Affairs to identify evidence gaps and generate real‑world data.
• Collaborate with Data Engineering to store, curate, and cross‑reference clinical data.

Communication, Thought Leadership & Outreach

• Participate in industry stakeholder groups and consortia such as BLOODPAC and the Global Alliance for Genomics and Health.
• Present to senior leadership, company‑wide, and at national scientific and clinical meetings.

Required

• PhD in physical/natural sciences or MD; strong cancer biology expertise preferred.
• 8+ years of leadership experience designing and developing clinical studies for pharmaceuticals or diagnostics, evidenced by publications or product releases.
• 3–5 years of experience in IVD diagnostics development.
• Knowledge of clinical and regulatory standards: ICH E6(R3) GCP, ISO 14155, ISO 13485, 21 CFR Part 820.
• 6–8 years of management experience, including recruiting, coaching, performance management, and career development.
• Excellent written and oral communication skills; mastery of presentations in large and small groups.
• Start‑up mindset: passionate, innovative, accountable, and able to prioritize and triage rapidly.
• Proactive, decisive, and composed with a balance of high IQ & EQ.

Preferred

• Familiarity with cutting‑edge AI (NLP/LLM for EHRs, digital twins, digital pathology) and international data standards (FAIR, FHIR‑OMOP, Common Data Models).

Salary: $260,000 – $320,000 per year (actual base pay depends on experience, skill, education, and geography). The role may also include an annual bonus, a new‑hire equity grant, and a comprehensive benefits package, including flexible time‑off, 401(k), medical, dental, and vision coverage, and wellness offerings.