CLIA Laboratory Director

Clinical Laboratory Director

Location: New Brunswick, NJ Area

Scientific Search has partnered with an exciting biotech company that is looking for an experienced Clinical Laboratory Director to lead and manage all operational, quality, and regulatory aspects of a state-of-the-art laboratory. This strategic leadership role requires a seasoned professional committed to establishing and maintaining the highest standards of laboratory operations, ensuring regulatory compliance, and driving innovation in diagnostic development. The Laboratory Director will be responsible for certifying and maintaining CLIA accreditation in collaboration with a CLIA regulatory consultant.

Responsibilities

• Ensure compliance with CLIA, FDA, and other regulatory standards.
• Work with a CLIA regulatory consultant to achieve and maintain CLIA certification.
• Develop and enforce SOPs, quality control, and proficiency testing programs.
• Lead and manage cross-functional teams, collaborating with future R&D, regulatory, and quality assurance team.
• Partner with the Executive Team and HR in staff hiring, training, and performance management.
• Implement ongoing staff education programs for competency and compliance.
• Partner with executive leadership to align laboratory operations with company goals.
• Implement new tests, equipment, and procedures to enhance lab capabilities.
• Oversee budget planning and resource allocation for cost-effective operations.
• Maintain a safe laboratory environment, mitigating physical and biological risks.
  
  

Requirements

• MD or Doctoral degree in chemical, physical, biological, or clinical laboratory science from an accredited institution.
• Minimum of 5 years of experience in a high-complexity laboratory setting.
• Strong leadership and organizational skills, with experience managing laboratory teams.
• Experience with FDA regulatory pathways and compliance is highly desirable.
• Proven ability to work cross-functionally, leading teams across different departments to achieve laboratory and company goals.
  
  

How To Apply: We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to tom@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume.