Medical Director & CLIA Laboratory Director

RDI - Your IVD CRO; Los Angeles (CA); Presencial; USD 180.000 - 260.000; A tiempo parcial

Ventajas ofrecidas por este puesto de trabajo

Part-time or fractional engagement

Descripción de la vacante

RDI Trials in Van Nuys, CA seeks a physician to assume laboratory director responsibilities and provide medical oversight for a portfolio of studies. You will work with sponsors, investigators, and our clinical team to ensure rigorous scientific standards and regulatory compliance.

This part-time or fractional role requires on-site presence, CLIA/CAP oversight experience, and the ability to translate client requirements into practical study protocols while guiding startup and enrollment.

Formación

• MD or DO with an active, unrestricted California medical license.
• Board certification in clinical pathology or anatomic and clinical pathology.
• Qualifications to assume laboratory directorship under applicable California/federal requirements.
• Experience directing a regulated clinical laboratory with CLIA/CAP oversight.
• Relevant diagnostic study, assay validation, or clinical research experience.
• Ability to fulfill PI responsibilities for assigned studies.
• Regular onsite work in Van Nuys, daytime availability.
• Willingness to review records, learn workflows, document decisions and follow-up.

Responsabilidades

• Direct the laboratory as the laboratory director of record and oversee quality and corrective actions.
• Oversee proficiency testing, personnel competency, method verification/validation, and CAP/CLIA matters.
• Maintain inspection readiness and respond to regulatory matters.
• Assess current test menu requirements and potential additions.
• Collaborate with staff to resolve scientific, quality, and testing issues.
• Lead assigned studies as Principal Investigator with oversight of conduct, data, and approvals.
• Participate in sponsor meetings, monitoring visits, protocol training, and closeout.
• Engage physicians and clients; secure site participation and manage startup/enrollment.

Conocimientos

MD or DO with California license

Board certification in clinical or an

Educación

MD or DO

Board certification in clinical pathology or AP/CP

Descripción del empleo

RDI Trials | Van Nuys, California

Part-time or fractional, with regular onsite involvement

RDI is a clinical research organization focused exclusively on in vitro diagnostics. We help diagnostic manufacturers execute studies through our physician network, clinical sites, and in-house CLIA-certified, CAP-accredited laboratory.

We have completed more than 300 trials. Our work spans clinical chemistry, mass spectrometry, molecular diagnostics, infectious disease, and other diagnostic applications.

We are seeking a physician to serve as our laboratory director, take responsibility for assigned studies as Principal Investigator, and work directly with sponsors and participating physicians.

The role

You will work alongside our CEO, COO, laboratory staff, and clinical operations team. Your first priorities will be assuming laboratory directorship and learning the active studies so that you can take responsibility for their medical and scientific oversight.

Our current portfolio includes complex mass-spectrometry stability studies involving multiple specimen types, collection conditions, and testing time points. Other programs involve prospective specimen collection, diagnostic performance evaluation, and assay validation.

You will need to understand how the work is performed, make informed decisions, and follow issues through to resolution.

Responsibilities

Direct the laboratory

• Serve as the laboratory director of record and fulfill the responsibilities of the appointment
• Oversee laboratory quality, proficiency testing, personnel competency, method verification and validation, and corrective actions
• Maintain inspection readiness and oversee responses to CAP, CLIA, and California laboratory regulatory matters
• Assess requirements for the current test menu and proposed additions
• Work directly with laboratory staff to resolve scientific, quality, and testing issues

Lead assigned studies as Principal Investigator

• Understand the protocol, laboratory workflow, study records, and delegated responsibilities
• Provide active oversight of study conduct, data, deviations, unresolved questions, and required approvals
• Participate in sponsor meetings, monitoring visits, protocol training, and closeout
• Identify execution risks and make clear recommendations to resolve them

Apply medical judgment to study design

• Review eligibility criteria, specimen requirements, collection timing, and testing plans
• Assess whether proposed procedures fit clinical practice and can be executed at participating sites
• Resolve medical and scientific questions with sponsors, investigators, and specialist advisors
• Help translate client requirements into practical protocols and work instructions

Engage physicians and clients

• Conduct physician outreach and explain study requirements
• Assess site feasibility through substantive discussions with investigators
• Help secure physician participation and resolve questions during startup and enrollment
• Join selected client calls to assess requirements and explain RDI's approach
• Identify assumptions that affect study feasibility, scope, timeline, and cost

Requirements

Required qualifications

• MD or DO with an active, unrestricted California medical license
• Board certification in clinical pathology or anatomic and clinical pathology
• Qualifications to assume laboratory directorship for RDI's actual testing scope under applicable federal and California requirements
• Experience directing a regulated clinical laboratory, including CLIA/CAP oversight
• Relevant diagnostic study, assay validation, or clinical research experience
• Ability to fulfill PI responsibilities for assigned studies, subject to study-specific requirements
• Dependable daytime availability and the ability to work regularly onsite in Van Nuys
• Willingness to review records, learn workflows, document decisions, and complete follow-up

Experience with IVD manufacturers, mass spectrometry, clinical chemistry, molecular diagnostics, and prospective specimen-collection studies is particularly valuable.

Benefits

What success looks like

Within three to six months, you will own laboratory-director responsibilities and the medical and scientific oversight of an agreed portfolio of studies. Laboratory staff, investigators, and sponsors will work directly with you on those matters, reducing the need for the CEO and COO to intervene in routine decisions.

Engagement

We are open to part-time employment or a fractional consulting arrangement. The commitment must provide sufficient time for onboarding, laboratory oversight, study ownership, scheduled meetings, and timely follow-through.

Laboratory directorship is a required part of the position. Appointment timing and eligibility will be verified before the transition.

Learn more about RDI's culture

Our CEO's open letter explains how we approach diagnostic trials, develop our people, and take responsibility for study outcomes. It offers context on the culture you would help lead as Medical Director. The videos from our CEO, COO, and team show the people and day-to-day work behind that approach.

Read the open letter

Watch the CEO and team videos