High Complexity Laboratory Director

Insight Global; Ann Arbor (MI); On-site; USD 180,000 - 320,000; Full time

Job summary

Insight Global is seeking a High Complexity Laboratory Director in Ann Arbor, MI. The role leads clinical laboratory operations, quality systems, and regulatory compliance for a CLIA/CAP-certified molecular diagnostics lab.

The candidate will oversee assay implementation, QC, and future diagnostic product development while partnering with R&D, Quality, Medical Affairs, and Operations teams. This is an onsite leadership role.

Qualifications

• PhD/MD/DO or equivalent doctoral degree satisfying CLIA education requirements.
• Current HHS-approved board certification; ABB High-complexity Molecular Diagnostics preferred.
• Hands-on experience with real-time PCR or RT-qPCR, nucleic-acid extraction, assay validation, QC and troubleshooting.
• Excellent technical judgment and strong written and verbal communication skills.
• At least two years directing or supervising high-complexity testing, plus CE credits.

Responsibilities

• Serve as senior scientific and regulatory leader of a CLIA/CAP-certified molecular diagnostics lab.
• Oversee operations, quality systems, and regulatory compliance.
• Lead assay implementation and future diagnostic product development.
• Partner with R&D, Quality, Medical Affairs, and Operations teams.

Skills

Real-time PCR

RT-qPCR

Nucleic-acid extraction

Assay validation

Quality control

Troubleshooting

Technical judgment

Written communication

Verbal communication

Clinical laboratory training

Laboratory supervision

Education

PhD/MD/DO or equivalent doctoral degree

HHS-approved board certification (ABB High-complexity)

Tools

Laboratory Information Systems (LIS)

Job description

Job Description

Insight Global is hiring a High Complexity Laboratory Director for an emerging healthcare client to serve as the senior scientific and regulatory leader of its CLIA/CAP-certified molecular diagnostics laboratory. This individual will oversee laboratory operations, quality systems, regulatory compliance, assay implementation, and future diagnostic product development while partnering closely with R&D, Quality, Medical Affairs, and Operations teams. This is a hands-on, onsite leadership role based in Ann Arbor, MI.

Skills and Requirements

• PhD, ScD, MD, DO, or equivalent doctoral degree that satisfies the current CLIA educational requirements.
• Current certification, maintained in good standing, by an HHS-approved board. ABB High-complexity Clinical Laboratory Director certification in Molecular Diagnostics is preferred.
• Hands-on experience with real-time PCR or RT-qPCR, nucleic-acid extraction, assay validation, quality control and troubleshooting.
• Excellent technical judgment and written and verbal communication skills.
• At least two years of applicable clinical laboratory training or experience, at least two years directing or supervising high complexity testing, and at least 20 continuing-education credit hours covering laboratory-director responsibilities, unless a current grandfather provision applies.

Preferred Qualifications

• New York State Certificate of Qualification in molecular oncology and genetic testing
• Experience supporting a high-throughput clinical laboratory, including assay performance monitoring, workflow improvement, automation, and laboratory information systems.
• Prior experience mentoring or supervising technical personnel.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].