FRACTIONAL CLIA LABORATORY DIRECTOR - Molecular Boarded MD, Pathology or ABMGG Board-Certified PhD

STAFF ICONS, LLC; Washington (District of Columbia); Presencial; USD 40.000 - 70.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

On-site role in DC

Fractional/Consulting engagement

Startup environment

Descripción de la vacante

Staff Icons is seeking an experienced Fractional CLIA Laboratory Director for an on-site role in Washington, DC. The candidate will lead regulatory compliance, quality systems, and laboratory operations for a startup pursuing FDA clearance or approval.

Ideal candidates hold an MD/DO/PhD with ABMGG Molecular Genetic Pathology board certification and have prior fractional/director experience, especially in CLIA-regulated labs. The position is one day per week on-site and consulting in nature.

Formación

• MD/DO/PhD from an accredited institution.
• Board certification in Molecular Genetic Pathology or ABMGG specialty.
• Experience with CLIA laboratory regulations, quality management and regulatory compliance.
• Ability to meet CLIA Laboratory Director qualifications.

Responsabilidades

• Serve as the designated CLIA Laboratory Director and ensure regulatory qualifications.
• Provide leadership over lab operations, QA, and regulatory compliance.
• Support FDA clearance/approval efforts with regulatory submissions and oversight.
• Guide testing procedures, validation, documentation, and quality systems.

Conocimientos

Leadership

Regulatory knowledge

Molecular pathology

Quality systems

Communication

Educación

MD/DO/PhD

ABMGG/Molecular Genetic Pathology board certification

Descripción del empleo

NOW HIRING: FRACTIONAL CLIA LABORATORY DIRECTOR - Molecular Boarded MD, Pathology or ABMGG Board-Certified PhD - Must have prior Fractional CLIA Laboratory Director for start up experience!!!

Location: Washington, DC

Schedule: 1 Day Per Week - Onsite

Position Type: Fractional / Part-Time / Consulting

Company: Start-Up Research Organization-Pending FDA Clearance

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

The company is actively working toward obtaining FDA clearance or approval for its technology and is seeking an experienced laboratory leader to provide scientific expertise, regulatory guidance, and laboratory oversight during this important phase of development.

This is an exciting opportunity for a board-certified Molecular Pathologist or an American Board of Medical Genetics and Genomics (ABMGG) board-certified PhD scientist to become involved with an emerging organization advancing innovative molecular technologies.

The position requires an onsite commitment of just one day per week, offering flexibility while playing an important role in establishing laboratory quality, regulatory compliance, and operational readiness.

Key Responsibilities

• Serve as the designated CLIA Laboratory Director, subject to applicable regulatory qualifications and approval.
• Provide leadership and oversight of laboratory operations, quality assurance, and regulatory compliance.
• Support the organization's efforts toward FDA clearance or approval by collaborating with scientific, regulatory, and executive leadership.
• Provide guidance on laboratory testing procedures, analytical validation, documentation, and quality systems relevant to regulatory submissions.
• Ensure laboratory policies and procedures meet applicable CLIA requirements.
• Oversee molecular testing methodologies, test validation, verification, and quality control activities as applicable.
• Assist with establishing and maintaining standard operating procedures (SOPs).
• Support laboratory inspection readiness, accreditation preparation, and regulatory documentation.
• Provide oversight of laboratory personnel qualifications, training, and competency assessments as applicable.
• Collaborate with the company's research and development teams to support scientific innovation and future clinical applications.

Required Qualifications

• MD, DO, or PhD from an accredited institution.
• Board certification in Molecular Genetic Pathology or an applicable American Board of Medical Genetics and Genomics (ABMGG) specialty.
• Expertise in molecular pathology, molecular genetics, or molecular diagnostic testing.
• Experience with CLIA laboratory regulations, quality management, and regulatory compliance.
• Ability to meet applicable CLIA Laboratory Director qualifications.
• Strong leadership, communication, and organizational skills.
• Availability to work onsite in Washington, DC, one day per week.

Preferred Qualifications

• Previous experience serving as a CLIA Laboratory Director or Medical Director.
• Experience with FDA-regulated diagnostic products, FDA clearance or approval processes, or regulatory submissions.
• Knowledge of molecular diagnostics, next-generation sequencing (NGS), genomic testing, or related technologies.
• Familiarity with CAP accreditation and laboratory inspections.
• Experience supporting start-up laboratories, biotechnology organizations, or research and development initiatives.
• Experience with analytical validation, laboratory quality systems, and regulatory readiness.

Why Consider This Opportunity?

• Flexible Schedule: Only one onsite day per week.
• Innovative Start-Up: Join an emerging research organization advancing molecular technologies.
• FDA Regulatory Milestone: Contribute to a company actively pursuing FDA clearance or approval.
• Leadership Opportunity: Help establish the scientific, operational, and regulatory foundation of a growing organization.
• Professional Flexibility: Ideal for an experienced Molecular Pathologist or ABMGG-certified PhD scientist seeking a fractional leadership engagement.
• Meaningful Impact: Play an important role in supporting the company's scientific development and future commercialization goals.

Connecting exceptional laboratory leaders with innovative organizations nationwide.