Medical Director & CLIA Laboratory Director

RDI•Van Nuys, CA

3d•Onsite

About The Position

RDI Trials is a clinical research organization focused exclusively on in vitro diagnostics. It supports diagnostic manufacturers in executing studies through a physician network, clinical sites, and an in-house CLIA-certified, CAP-accredited laboratory. Its work spans clinical chemistry, mass spectrometry, molecular diagnostics, infectious disease, and other diagnostic applications, and the organization has completed more than 300 trials. The Medical Director & CLIA Laboratory Director will serve as laboratory director, assume responsibility as Principal Investigator for assigned studies, and work directly with sponsors and participating physicians. The role works alongside the CEO, COO, laboratory staff, and clinical operations team. Initial priorities include assuming laboratory directorship and learning active studies in order to take responsibility for their medical and scientific oversight. The current portfolio includes complex mass-spectrometry stability studies involving multiple specimen types, collection conditions, and testing time points, as well as prospective specimen collection, diagnostic performance evaluation, and assay validation programs. The director will understand how laboratory and study work is performed, make informed decisions, and follow issues through to resolution. The role includes overseeing laboratory quality and regulatory readiness; providing active PI oversight of assigned studies; applying medical judgment to study design and execution; and engaging physicians, investigators, sponsors, and clients. Regular onsite involvement in Van Nuys and dependable daytime availability are required. RDI is open to part-time employment or a fractional consulting arrangement, provided the commitment allows for onboarding, laboratory oversight, study ownership, scheduled meetings, and timely follow-through. Laboratory directorship is a required part of the position, and appointment timing and eligibility will be verified before transition.

Requirements

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 Principal Investigator responsibilities for assigned studies, subject to study-specific requirements.
Dependable daytime availability.
Ability to work regularly onsite in Van Nuys.
Willingness to review records, learn workflows, document decisions, and complete follow-up.

Nice To Haves

Experience with IVD manufacturers.
Experience with mass spectrometry.
Experience with clinical chemistry.
Experience with molecular diagnostics.
Experience with prospective specimen-collection studies.

Responsibilities

Serve as 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 with laboratory staff to resolve scientific, quality, and testing issues.
Lead assigned studies as Principal Investigator by understanding protocols, laboratory workflows, study records, and delegated responsibilities.
Actively oversee study conduct, data, deviations, unresolved questions, and required approvals.
Participate in sponsor meetings, monitoring visits, protocol training, and study closeout.
Identify study execution risks and make clear recommendations to resolve them.
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.
Translate client requirements into practical protocols and work instructions.
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 affecting study feasibility, scope, timeline, and cost.
Learn active studies and assume medical and scientific oversight of an agreed portfolio.
Review records, learn workflows, document decisions, and complete follow-up.