Senior Director, Research Strategy and Operations (Core Team Leader)

Location: Chicago, hybrid

Salary: $192,000–$264,000 USD annually

Company

hirify.global develops precision-medicine products by connecting real-world evidence, AI, and clinical data to support treatment decisions.

What you will do

• Own accountability for the product development lifecycle, ensuring delivery against the Target Product Profile, product requirements, and timeline.
• Lead a cross-functional Core Team spanning Science, Engineering, Quality, Regulatory, Clinical, Lab Operations, Software, and Operations without direct line authority.
• Drive consensus, resolve friction, identify root causes and critical-path risks, and make trade-off decisions across scope, timeline, and resources.
• Lead formal Stage-Gate Reviews and synthesize technical, clinical, and operational information into actionable narratives for executive leadership.
• Guide Design Control-compliant development under 21 CFR 820 and ISO 13485, including LDT, 510(k), and PMA pathways.
• Oversee the transition from R&D to Clinical Lab Operations and ensure scalable order-to-result workflows and market-ready product value.

Requirements

• Advanced degree required: PhD, MD, or MS in Genetics, Molecular Biology, or Engineering.
• 10+ years of experience in the life sciences or diagnostics industry, including at least 4+ years as a Core Team Leader, Product Development Lead, or Program Director in a matrixed environment.
• Deep experience in Oncology Diagnostics, NGS, or Liquid Biopsy.
• Expert knowledge of Phased-Gate or Stage-Gate development cycles.
• Strong communication and emotional intelligence for managing executive-level stakeholders.
• Demonstrated ability to influence without authority and guide senior functional experts.
• Ability to communicate effectively with R&D scientists and Commercial leaders.
• Focus on manufacturability and operational scalability of diagnostic tests.

Nice to have

• MBA.
• Experience with FDA Class II/III medical device development, including PMA or 510(k).

Culture & Benefits

• Hybrid work arrangement in Chicago.
• Benefits may include incentive compensation, restricted stock units, medical benefits, and other benefits depending on the position.