Director of IVD Clinical Affairs

IQVIA•Washington, DC

About The Position

The Clinical Director, IVD MedTech is a senior clinical leadership role responsible for the scientific, regulatory, and operational oversight of In‑Vitro Diagnostics (IVD) clinical trials conducted by IQVIA MedTech. This position provides specialized IVD subject‑matter expertise, sponsor‑facing leadership, and accountable clinical direction across the full lifecycle of IVD clinical programs. The Clinical Director plays a critical role in expanding IQVIA’s IVD CRO capabilities by ensuring studies are executed in compliance with GCP, applicable regulations, SOPs, and evolving IVD‑specific regulatory expectations. The role is both strategic and hands‑on, supporting client delivery, business development, and long‑term practice growth.

Requirements

Bachelor’s degree in a healthcare, life sciences, or related discipline required.
7–10+ years of experience in clinical research, with at least 5 years of direct IVD clinical trial experience.
Minimum of 4 years of people leadership or supervisory experience in a CRO or clinical research environment.
Demonstrated experience leading multiple, concurrent IVD studies of varying complexity.
Deep working knowledge of IVD clinical trial design, execution, and regulatory expectations.
Expert‑level understanding of GCP, clinical monitoring practices, and CRO operations specific to IVD products.
Experience supporting clinical programs across different IVD product types and use cases.
Familiarity with EDC, CTMS, and other clinical systems used in IVD trial management.
Proven ability to independently manage sponsors and senior client stakeholders.
Strong clinical judgment with the ability to assess risk, escalate issues, and drive resolution.
Demonstrated ability to lead, coach, and hold teams accountable for quality and delivery.
Experience working with senior leadership and executive‑level stakeholders.
Excellent written and verbal communication skills.
Strong organizational and prioritization skills in a fast‑paced, multi‑project environment.
Ability to adapt quickly to regulatory and industry changes specific to IVD.
Advanced proficiency with MS Office (Outlook, Word, PowerPoint, Excel).

Responsibilities

Provide senior clinical leadership for IVD‑specific clinical trials, including feasibility, execution, and close‑out.
Ensure clinical strategy, study design, and execution are appropriate for IVD products, intended use, and regulatory pathways.
Oversee protocol development, clinical plans, and study documentation for accuracy, completeness, and regulatory compliance.
Serve as an escalation point for clinical, safety, and quality issues across IVD studies.
Act as the primary clinical point of contact for sponsors on assigned IVD programs.
Review and approve clinical reports, study communications, and sponsor deliverables.
Provide clear, data‑driven clinical updates and respond to sponsor questions and concerns.
Build and maintain strong relationships with sponsors, investigators, and clinical sites experienced in IVD studies.
Ensure IVD studies are properly resourced, executed on time, and managed within budget.
Ensure adherence to GCP, IQVIA SOPs, and IVD‑specific regulatory and quality requirements.
Collaborate with Clinical Quality Assurance on vendor selection, oversight, audits, and inspection readiness.
Drive consistency across study execution, documentation standards, and training.
Provide direct leadership, mentorship, and professional development to Project Managers, CRAs, and CTAs supporting IVD programs.
Identify departmental training needs related to IVD clinical trials and ensure implementation.
Support hiring, onboarding, performance management, and succession planning within the IVD clinical team.
Collaborate with IQVIA MedTech and related business units on IVD‑focused business development, including proposals and bid defenses.
Provide subject‑matter expertise to support new client opportunities and service expansion in IVD.
Contribute to the development and evolution of IQVIA’s IVD clinical service offerings.
Serve as a clinical project lead on IVD programs as needed, particularly for early‑stage or high‑complexity studies.
Support cross‑functional alignment across Clinical Operations, Regulatory, Quality, and Biostatistics.