The company is actively advancing its investigational diagnostic technology toward an FDA 510(k) submission and is seeking an accomplished laboratory leader to provide scientific, technical, operational, and quality oversight during this important development phase. If you are an experienced Molecular Pathologist or PhD laboratory scientist with molecular diagnostics expertise and an interest in fractional laboratory leadership, we would welcome a confidential conversation.

FRACTIONAL CLIA LABORATORY DIRECTOR

****MUST HAVE FRACTIONAL CLIA LABORATORY EXPERIENCE IN A START UP ENVIRONMENT​****

Molecular Pathology Boarded MD, DO or ABMGG Board-Certified PhD

Location: Washington, DC
Schedule: Approximately 1 Day Per Week Onsite, with Remote Availability as Needed
Position Type: Fractional / Part-Time / Consulting
Company: Confidential – Innovative Molecular Diagnostics Start-Up
FDA Status: Investigational Diagnostic Technology – Working Toward FDA 510(k) Clearance
Recruitment Firm: Staff Icons, LLC – Pathologist Recruitment Division  

SEND CV:

APPLY@STAFFICONS.COM

Exciting Scientific Leadership Opportunity!

Staff Icons is seeking an experienced Fractional Laboratory Director for an innovative molecular diagnostics start-up located in Washington, DC.

This emerging organization is developing a cutting-edge, blood-based RNA molecular diagnostic assay utilizing multiplex digital PCR technology to support infectious disease detection.

The company is actively advancing its investigational diagnostic technology toward an FDA 510(k) submission and is seeking an accomplished laboratory leader to provide scientific, technical, operational, and quality oversight during this important development phase.

This is an exceptional opportunity for a Molecular Pathologist (MD/DO) or experienced PhD laboratory scientist, preferably ABMGG board-certified, to contribute to groundbreaking molecular diagnostic technology without a full-time commitment.

The position offers a flexible fractional consulting arrangement requiring approximately one day per week onsite in Washington, DC, with additional remote availability as needed.

Key Responsibilities

Scientific & Molecular Laboratory Leadership

• Provide scientific, technical, and operational oversight of an investigational molecular diagnostics laboratory.
• Direct laboratory activities involving molecular assay development, optimization, verification, and analytical validation.
• Oversee blood-based RNA biomarker testing and multiplex digital PCR workflows.
• Ensure scientific accuracy, reproducibility, analytical validity, and integrity of laboratory-generated data.
• Review and approve laboratory protocols, validation studies, acceptance criteria, and technical conclusions within assigned authority.
• Evaluate assay performance, including precision, sensitivity, specificity, reproducibility, interference, contamination, and specimen stability.

FDA Regulatory & Quality Management

• Support the company's efforts toward FDA 510(k) clearance by providing scientific guidance and laboratory validation evidence.
• Collaborate with Regulatory Affairs and Quality Assurance (RA/QA) teams to support FDA Quality Management System Regulation (QMSR) and ISO 13485:2016 requirements.
• Assist with laboratory design verification, validation, risk assessments, and regulatory documentation.
• Establish and maintain appropriate laboratory quality systems, SOPs, and controlled documentation.
• Support investigations, corrective and preventive actions (CAPA), internal audits, and quality improvement initiatives.
• Ensure laboratory data and documentation are accurate, traceable, and suitable for regulatory review.

Laboratory Operations & Personnel Oversight

• Provide technical guidance and supervision to laboratory personnel.
• Oversee personnel qualifications, training, competency assessments, and laboratory procedures.
• Ensure appropriate instrument qualification, calibration, maintenance, and quality control.
• Maintain laboratory safety, contamination prevention, and appropriate specimen-handling practices.
• Collaborate with scientific leadership, research teams, and regulatory personnel.
• Participate in laboratory resource planning, equipment recommendations, and operational improvements.

Required Qualifications

• MD, DO, PhD, or equivalent doctoral qualification in Molecular Pathology, Molecular Biology, Genetics, Clinical Laboratory Science, Microbiology, Biochemistry, or a closely related discipline.
• Substantial experience in molecular diagnostics, laboratory leadership, complex molecular workflows, and analytical validation.
• Demonstrated knowledge of laboratory quality systems, scientific documentation, and data integrity.
• Experience evaluating experimental design, analytical performance, study limitations, and technical findings.
• Strong communication, leadership, and organizational skills.
• Ability to provide approximately one day per week of onsite leadership in Washington, DC, with remote availability as needed.

Highly Preferred Qualifications

• Board certification in Molecular Genetic Pathology or an applicable American Board of Medical Genetics and Genomics (ABMGG) specialty.
• Previous experience serving as a Laboratory Director, CLIA Laboratory Director, Medical Director, or fractional laboratory consultant.
• Expertise in RNA biomarkers, molecular infectious disease diagnostics, multiplex digital PCR, or related technologies.
• Experience with FDA 510(k) submissions, investigational in vitro diagnostics (IVD), or medical device development.
• Knowledge of ISO 13485, FDA QMSR, ISO 15189, and laboratory quality management systems.
• Experience supporting laboratory start-ups, biotechnology companies, or emerging diagnostic technologies.
• Familiarity with clinical specimens, molecular assay development, analytical validation, and regulatory readiness.

Why Consider This Opportunity?

Flexible Fractional Schedule
Approximately one day per week onsite, allowing experienced professionals to maintain other professional commitments.

Innovative Molecular Technology
Contribute to the development of an investigational RNA-based molecular diagnostic assay with potential future clinical applications.

FDA Regulatory Milestone
Play a meaningful role in generating the laboratory validation evidence needed to support a planned FDA 510(k) submission.

Scientific Leadership & Influence
Help shape laboratory operations, quality systems, scientific standards, and future organizational growth.

Ideal Consulting Opportunity
Well suited for an established Molecular Pathologist, ABMGG-certified PhD scientist, or experienced laboratory leader interested in an additional fractional engagement.

Interested in Learning More?

If you are an experienced Molecular Pathologist or PhD laboratory scientist with molecular diagnostics expertise and an interest in fractional laboratory leadership, we would welcome a confidential conversation.

Please forward your updated CV and best contact number to:

Dawn Foster
CEO/Founder
Staff Icons, LLC – Pathologist Recruitment Division
Email:

Apply@stafficons.com

Cell/Text: 845-321-0777
Headquarters: 201-986-7888
Website: www.stafficons.com

Connecting exceptional laboratory leaders with innovative organizations nationwide.