Director of IVD Clinical Affairs

Position Overview

The Clinical Director IVD MedTech is a senior clinical leadership role responsible for the scientific regulatory and operational oversight of InVitro Diagnostics (IVD) clinical trials conducted by IQVIA MedTech. This position provides specialized IVD subjectmatter expertise sponsorfacing leadership and accountable clinical direction across the full lifecycle of IVD clinical programs.

The Clinical Director plays a critical role in expanding IQVIAs IVD CRO capabilities by ensuring studies are executed in compliance with GCP applicable regulations SOPs and evolving IVDspecific regulatory expectations. The role is both strategic and handson supporting client delivery business development and longterm practice growth.

Position Responsibilities

IVD Clinical Leadership & Oversight

• Provide senior clinical leadership for IVDspecific clinical trials including feasibility execution and closeout.
• 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.

Sponsor & Stakeholder Engagement

• 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 datadriven clinical updates and respond to sponsor questions and concerns.
• Build and maintain strong relationships with sponsors investigators and clinical sites experienced in IVD studies.

Operational & Quality Governance

• Ensure IVD studies are properly resourced executed on time and managed within budget.
• Ensure adherence to GCP IQVIA SOPs and IVDspecific 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.

People Leadership & Capability Development

• 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.

Business Development & Growth

• Collaborate with IQVIA MedTech and related business units on IVDfocused business development including proposals and bid defenses.
• Provide subjectmatter expertise to support new client opportunities and service expansion in IVD.
• Contribute to the development and evolution of IQVIAs IVD clinical service offerings.

HandsOn Project Support

• Serve as a clinical project lead on IVD programs as needed particularly for earlystage or highcomplexity studies.
• Support crossfunctional alignment across Clinical Operations Regulatory Quality and Biostatistics.

Required Qualifications

Education & Experience

• Bachelors degree in a healthcare life sciences or related discipline required.
• 710 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.

IVD & Regulatory Expertise

• Deep working knowledge of IVD clinical trial design execution and regulatory expectations.
• Expertlevel 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.

Leadership & Client 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 executivelevel stakeholders.

Core Competencies

• Excellent written and verbal communication skills.
• Strong organizational and prioritization skills in a fastpaced multiproject environment.
• Ability to adapt quickly to regulatory and industry changes specific to IVD.
• Advanced proficiency with MS Office (Outlook Word PowerPoint Excel).

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status as a protected veteran or any other status protected by applicable law. is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.