Senior Manager, Companion Diagnostics (CDx)

Location: Chicago, Illinois, United States

Salary: $120,000–$165,000 per year for roles performed from Illinois; the range may vary for California, Colorado, and New York.

Company

hirify.global provides an AI-powered precision medicine platform that connects real-world evidence with clinical insights for healthcare providers and pharmaceutical partners.

What you will do

• Lead the initial scoping and planning of Companion Diagnostic clinical validation projects and contracts.
• Develop diagnostic protocols by translating drug trial strategies into clinical diagnostic validation strategies.
• Define clinical data generation, analysis plans, and biostatistical approaches with subject matter experts.
• Coordinate internal Pharma sequencing, QA, CRO, and Regulatory teams with external IVD consultants and drug trial sponsors.
• Manage the day-to-day execution and oversight of regulatory-grade CDx clinical studies.
• Ensure project delivery, resourcing, regulatory compliance, and completion within agreed timelines.

Requirements

• Ph.D. or Master’s degree in a relevant discipline preferred, or equivalent professional experience.
• At least 5 years of experience in IVD or medical device development, including at least 2 years in clinical study design and execution.
• Experience setting up, monitoring, and reporting GCP-grade studies, including trial master file documentation and FDA strategies.
• Ability to understand biostatistical strategies and develop strategic workplans and Statistical Analysis Plans with subject matter experts.
• Understanding of CDx clinical development, clinical validation strategies, good clinical practices, and applicable regulatory requirements.
• Ability to communicate clearly and coordinate resources across internal and external stakeholders.

Culture & Benefits

• Work focused on precision medicine and applying AI to clinical care.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other position-dependent benefits.
• Equal opportunity employment without discrimination based on protected characteristics.