Senior Director, Research & Development (Molecular Diagnostics)

Location: Chicago, Illinois, United States

Salary: $173,000–$245,000 annually for roles performed in Illinois; compensation may vary for California, Colorado, and New York.

Company

hirify.global develops a precision medicine platform that connects real-world evidence with clinical insights and diagnostics.

What you will do

• Lead late-stage development, validation, and launch readiness for molecular diagnostic products, including IVD, CDx, IUO, and LDT programs.
• Provide scientific and strategic leadership for design controls, validation planning, design transfer, and post-launch changes.
• Partner with Regulatory, Quality, Clinical Lab Operations, Bioinformatics, Automation, Program Management, and Pharma Business Development.
• Support regulatory submissions and requirements across FDA, IVDR, MolDX, NYS, CAP, and other regional frameworks.
• Build scalable documentation and development processes supporting inspection readiness, traceability, and continuous improvement.
• Lead complex issue resolution, external development programs, resource planning, budgeting, and organizational development.

Requirements

• PhD with 8+ years of experience or Master’s degree with 13+ years of experience in molecular diagnostics, assay development, or a related life sciences field in a regulated environment.
• Deep experience leading design-controlled development for molecular diagnostics or sequencing-based assays.
• Strong knowledge of IVD/CDx development, validation, design transfer, and regulatory submissions.
• Experience with FDA, IVDR, ISO 13485, QMSR, MolDX, and NYS regulated frameworks.
• Track record of leading cross-functional teams through complex technical and regulatory milestones.
• Strong people management experience, including hiring, mentoring, and leading teams through growth and change.

Nice to have

• Experience with audits, inspections, pre-submissions, deficiency responses, and approval pathways.
• Experience with companion diagnostics, pharmaceutical partnerships, and external development programs.
• Experience with automation, LIMS, and 21 CFR Part 11-compliant tools such as ELNs.

Culture & Benefits

• Full-time employment with a comprehensive benefits package.
• Benefits may include incentive compensation, restricted stock units, medical coverage, and other benefits depending on the position.
• Opportunity to mentor and develop teams of scientists and documentation specialists.
• Work focused on scientifically robust, operationally scalable, and inspection-ready diagnostic products.