Senior Director, Clinical Development

DELFI Diagnostics, Inc.; Palo Alto (CA); On-site; USD 260,000 - 320,000; Full time

Benefits offered by this job

Flexible time-off

401(k)

Medical, dental, and vision coverage

Wellness offerings

Job summary

DELFI Diagnostics, Inc. is seeking a Sr. Director, Clinical Development to lead its clinical study portfolio. This role requires shaping clinical strategies and working closely with cross-functional teams in R&D, medical, and regulatory domains.

The ideal candidate will possess a PhD or MD, significant experience in IVD diagnostics, and a strong foundation in cancer biology. This position offers a competitive salary and a comprehensive benefits package including flexible time off, 401(k), and wellness programs.

Qualifications

• 8+ years leading clinical studies in pharmaceuticals or diagnostics with proven results.
• 3–5 years experience in IVD diagnostics development.
• Strong communication skills for presentations and stakeholder engagement.

Responsibilities

• Develop and execute clinical studies generating robust evidence.
• Interact with FDA on IVD product submissions.
• Manage clinical operations and vendor relationships.

Skills

Leadership in clinical studies

Cancer biology expertise

Regulatory standards knowledge

Communication skills

Education

PhD in physical/natural sciences or MD

Tools

Statistical analysis software

Job description

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 EvaLuation of Fragments for early Interception (DELFI), uses fragmentomics to identify cancer cells from cell‑free DNA. FirstLook Lung is a laboratory‑developed screening test for individuals eligible for lung cancer screening.

About this Role

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.

What You’ll Do

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.

What You’ll Bring

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).

Compensation

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.