Clinical Laboratory Director

Elixir Associates; Cincinnati (OH); On-site; USD 180,000 - 240,000; Full time

Job summary

Elixir Associates in Cincinnati is seeking a Clinical Laboratory Director to lead scientific and regulatory oversight of North American Central Safety and Cellular Laboratories within a global clinical research organisation.

The role involves directing two laboratories, overseeing high-complexity testing, and acting as the clinical authority in discussions with FDA, CAP, and other regulators. Relocation support and a strong sign-on are offered.

Qualifications

• MD/PhD with CLIA and CAP High Complexity Laboratory Director qualifications.
• Board certification in Clinical Pathology or equivalent.
• At least five years in a clinical laboratory across multiple disciplines.

Responsibilities

• Provide scientific and regulatory oversight for the North American Central Safety and Cellular Laboratories.
• Lead the credentialed technical team and ensure quality, safety and regulatory compliance.

Skills

Clinical leadership

Regulatory compliance

Cross-discipline expertise

Education

MD or PhD in clinical laboratory science or related field

Board certification such as ABP Clinical Pathology or equivalent

Job description

Clinical Laboratory Director | Greater Cincinnati | Relocation supported/ Strong Sign-On Offered

We're recruiting a Clinical Laboratory Director for a global clinical research organisation, leading the scientific and regulatory oversight of their North American Central Safety and Cellular Laboratories.

This is rare; most high-complexity lab director roles sit inside hospital systems or reference labs, where the work is high volume and largely routine. This one sits inside clinical trials. The testing you do directly supports sponsor programmes, regulatory submissions and patient safety decisions across global studies.

What makes this different

• Every result your laboratory releases feeds a sponsor's clinical trial, a regulatory submission, or a decision about whether a patient stays on study.
• Two laboratories, two disciplines, one director. Central safety chemistry and haematology on one side, cellular and flow cytometry on the other. Very few CLIA directorships give you both.
• You will be the clinical voice in front of the FDA, CAP, EMA and ISO.
• Sponsors will ask you what their data means. This role puts you in direct client conversations as the scientific authority- a chance for meteoric progression/ rare opportunities.
• You design the assays. Rather than running a fixed set of SOPs someone else built, you validate and maintain testing built around what each programme actually needs.
• A credentialed technical team reports through you

The organisation

Privately held. Cash bonuses paid every year for the past decade. Around a quarter of global staff are promoted annually, with a structured mentoring programme and tuition reimbursement behind it.

What you will need

• MD or PhD in clinical laboratory science, or a chemical, physical or biological science, meeting CLIA and CAP requirements for High Complexity Laboratory Director
• Board certification such as ABP Clinical Pathology, ABB, ABCC, ABMM, ABMLI, ABMGG, or ABIM Hematology, or equivalent documented training and experience
• At least five years in a clinical laboratory across multiple disciplines