Clinical Lab Director (Part-Time)

Spear Bio, Inc.

Job Overview

Location

Remote

Job Type

Full-time

Full Job Description

📋 Description

• Serve as the CLIA Laboratory Director for Spear Bio’s high-complexity clinical laboratory, providing clinical, scientific, and regulatory oversight to ensure accurate, reliable, and high-quality testing services in compliance with CLIA, CAP, and Massachusetts state requirements.
• Oversee laboratory quality management system, review and approve policies, procedures, test validations, and quality documentation, monitor performance, and implement continuous quality improvement initiatives.
• Provide clinical consultation to physicians and healthcare providers regarding test interpretation and support laboratory readiness for regulatory inspections and accreditation surveys.
• Foster a culture of quality, compliance, and scientific excellence while supporting Spear Bio’s CLIA/CAP certification readiness and early clinical laboratory operations in a remote, part-time consulting role.

🎯 Requirements

• M.D., D.O., or Ph.D. in a relevant scientific discipline (e.g., immunology, pathology, clinical chemistry, biochemistry, molecular biology).
• Qualified to serve as Clinical Laboratory Director of a high-complexity CLIA laboratory under federal and Massachusetts state regulations, with a required Clinical Laboratory Director License from the Massachusetts Department of Public Health (MDPH).
• Board certification in a relevant discipline (e.g., Clinical Chemistry, Clinical Pathology, HCLD, Immunology).
• Minimum 8-10 years of experience in high complexity clinical laboratory operations, including at least 5 years in a director-level role overseeing a CAP/CLIA-certified laboratory.
• Proven track record of successfully establishing or scaling a clinical lab.
• Demonstrated expertise in immunoassay technologies, assay validation and verification, laboratory quality systems, proficiency testing, and inspection readiness.
• Experience with LIMS platforms, electronic quality management systems (eQMS), and workflow automation in high-complexity testing environments.
• Experience working in a fast-paced, early-stage startup.

🏖️ Benefits

• Competitive compensation.
• Meaningful stock ownership.
• Comprehensive benefits.
• Great work environment.
• Opportunity to join an innovative, high-growth biotech startup at an early stage.
• Play an integral role in building an industry-leading company focused on revolutionizing early disease diagnosis.

Skills & Technologies

Remote

Ready to Apply?

Apply Externally

You will be redirected to an external site to apply.

AI Job Fit Analysis

Pro

See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.

Spear Bio, Inc.

Visit Website

About Spear Bio, Inc.

Spear Bio, Inc. is a biotechnology company focused on developing next-generation protein therapeutics using its proprietary computational platform to design and optimize biologics with enhanced stability, efficacy, and manufacturability. The company leverages machine learning and structural biology to target challenging disease areas, including oncology and immunology, with a pipeline of engineered antibodies and protein-based drugs. Spear Bio aims to overcome limitations of traditional biologics by creating molecules that resist degradation and maintain function in harsh physiological conditions. The company collaborates with pharmaceutical partners and has received funding from venture capital firms specializing in life sciences innovation. Its work sits at the intersection of AI-driven drug discovery and protein engineering, positioning it as a leader in the emerging field of computational biologics design.

View Company Profile

Get more remote jobs like this

Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.

Weekly remote jobs and featured talent.

No spam. Only curated remote roles and product updates. You can unsubscribe anytime.