Executive Director/Site Head (Medtech)

TL;DR

Executive Director/Site Head (Medtech): Overseeing laboratory operations across multiple functional groups in Frederick, MD, with an accent on regulatory compliance and operational excellence. Focus on ensuring scientific standards, managing cross-functional teams, and driving revenue delivery while maintaining rigorous FDA, CAP/CLIA, and ISO standards.

Location: Must be based onsite in Frederick, MD

Salary: $203,200 - $304,800 USD

Company

hirify.global is a specialized services provider supporting the development and commercialization of life-changing therapies.

What you will do

• Oversee operational aspects for Bioanalysis, Flow Cytometry, and Companion Diagnostic laboratories.
• Mentor and lead laboratory heads to ensure scientific excellence and consistent standards.
• Collaborate with facilities, quality assurance, and finance departments to optimize site performance.
• Monitor and report site KPIs including quality events, turnaround time, and budget adherence.
• Represent the site in FDA calls regarding assay development and regulatory compliance.
• Manage client expectations and serve as a technical escalation point for project-related issues.

Requirements

• Ph.D. in Immunology or a related field required.
• Minimum 12+ years of relevant experience, including 6+ years in industry and 6+ years in leadership.
• Deep current knowledge of FDA guidance, IVDR, ISO 13485, 15189, and CLIA/CLSI validation requirements.
• Direct working experience in cell-based assays or bioanalysis for clinical studies.
• Must be able to work onsite in Frederick, MD.
• Fluent English proficiency required.

Nice to have

• Experience working at a CRO, Biotechnology, or Pharmaceutical company.
• Expertise in technology platforms including ECL, ligand-binding assays (LBA), and enzymatic activity assays.

Culture & Benefits

• Comprehensive health insurance and retirement savings benefits.
• Discretionary annual bonus program.
• Paid time off for vacation and sick leave.
• Parental leave and disability benefits.
• Equal Opportunity Employer committed to a diverse and inclusive workplace.