Senior Director, Clinical Development (IVD Diagnostics)

Location: Palo Alto, California, United States; hybrid workplace with 1–2 designated in-office days per week for employees living within 50 miles of Palo Alto

Company

hirify.global develops cancer diagnostic products focused on rigorous clinical evidence, quality, transparency, and broad patient impact.

What you will do

• Develop and execute clinical studies establishing clinical validity and clinical utility for current and future diagnostic product claims.
• Advance cancer diagnostic products, beginning with lung cancer detection in USPSTF-eligible individuals.
• Implement the five-year clinical development strategy based on clinical science, evidence gaps, and unmet needs in cancer diagnostics.
• Partner with R&D Biostatistics to design and analyze case-control and prospective studies according to protocols and statistical analysis plans.
• Lead clinical development and clinical operations groups, CROs, investigators, vendors, sites, patient enrollment, and follow-up.
• Manage clinical trial timelines, budgets, risks, FDA interactions, IVD documentation, and real-world evidence generation.

Requirements

• PhD in physical or natural sciences, or an MD; cancer biology expertise is strongly preferred.
• At least 8 years of experience leading clinical study design and development in pharmaceutical or diagnostics development.
• 3–5 years of experience in IVD diagnostics development.
• Knowledge of ICH E6(R3) GCP, ISO 14155, ISO 13485, and 21 CFR Part 820.
• 6–8 years of management experience, including recruiting, coaching, performance management, and career development.
• Excellent written and oral communication skills, including presentations to senior leadership and scientific or clinical audiences.

Nice to have

• Experience with AI approaches in clinical trials, including NLP or LLM applications for EHRs, digital twins, or digital pathology.
• Familiarity with FAIR principles, FHIR-OMOP, or Common Data Models.

Culture & Benefits

• Science-led environment emphasizing quality, transparency, rigor, and practical execution.
• Collaborative culture focused on collective intelligence, empathy, humility, and integrity.
• Start-up mindset with rapid prioritization, accountability, innovation, and bias toward action.
• Hybrid work arrangement with designated office collaboration days for employees near Palo Alto.