Executive Director Of Companion Diagnostics (Site Head)

TL;DR

Executive Director of Companion Diagnostics (Site Head): Overseeing laboratory operations and CDx programs in Frederick, MD, with an accent on scientific excellence, regulatory compliance, and operational efficiency. Focus on leading multi-functional teams, advancing assay development for Cell and Gene Therapy, and ensuring high-quality data generation across bioanalytical and flow cytometry platforms.

Location: Must be based in Frederick, MD, USA

Salary: $227,600–$341,400 USD

Company

hirify.global is a specialized services organization supporting the development and commercialization of innovative therapies.

What you will do

• Provide full operational oversight of laboratory functions including Bioanalysis, Flow Cytometry, and Companion Diagnostics.
• Lead, hire, and develop high-performing scientific and laboratory teams.
• Ensure compliance with FDA, IVDR, ISO, CLIA, and GxP regulatory standards.
• Drive operational excellence through capacity planning, resource allocation, and KPI management.
• Serve as a subject matter expert in CDx assay development and represent the organization to clients.
• Coordinate cross-functional activities to streamline product lifecycle management from concept to commercialization.

Requirements

• Ph.D. in Immunology or a related scientific field.
• 20 years of relevant experience, including 12 years as a functional manager.
• Deep expertise in Companion Diagnostics within the Cell and Gene Therapy space.
• Strong knowledge of FDA guidance and global regulatory frameworks (IVDR, ISO 13485/15189, CLIA, CAP, GxP).
• Proven experience developing and validating assays for clinical studies.
• Demonstrated leadership managing multi-functional laboratory teams.

Nice to have

• Experience within a CRO, biotechnology, or pharmaceutical organization.
• Expertise in ligand-binding assays (LBA), electrochemiluminescence (ECL), and enzymatic activity assays.

Culture & Benefits

• Discretionary annual bonus eligibility.
• Comprehensive health insurance, life insurance, and disability benefits.
• Retirement savings benefits.
• Parental leave and paid time off for sick leave and vacation.