Senior Phase I Clinical Trial Leader

IQVIA Inc; Wien; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

IQVIA is seeking a Clinical Trial Leader/Senior Clinical Trial Leader to drive end-to-end Phase I Healthy Volunteer studies within Clinical FSP. You will steer study design, protocol development, and cross-functional execution, aligning medical and pharmacology partners to deliver high-quality, timely trials.

You will lead interdisciplinary teams, manage safety and data interpretation, and maintain governance through transparent communication and risk-based planning.

Qualifications

• Recent Phase I Healthy Volunteer leadership with end-to-end accountability.
• Strong knowledge of early phase study designs, protocol authoring and clinical pharmacology.
• Ability to contribute to dose-escalation strategy and interpretation of safety/PK-PD data.
• Ability to align medical, clinical pharmacology and statistical partners.

Responsibilities

• Provide leadership to core and extended trial teams for Phase I HV studies from preparation to reporting.
• Drive study design and protocol strategy with cross-functional partners to ensure ethical, feasible and robust designs.
• Support dose-escalation decisions and integrate safety/PK/PD data for governance.
• Create and coordinate essential trial documents (protocols, ICFs, quality plans).
• Plan clinical-unit and vendor delivery including site selection, recruitment and biosampling dependencies.
• Lead governance/communication with stakeholders and drive timely decisions.
• Manage safety, risk and escalation with timely action and escalation.
• Foster cross-functional alignment of requirements into actionable plans.
• Oversee CROs, labs, vendors with scope, quality and financial control.
• Maintain GCP/ICH compliance and inspection readiness.
• Use dashboards and data reviews to drive performance and milestones.
• Contribute to early-development strategy and regulatory responses.

Skills

Phase I HV leadership

Early phase study design

Protocol development & clinical PK/PD

Dose-escalation knowledge

Cross-functional leadership

Risk-based delivery

Communication excellence

Regulatory knowledge (GCP/ICH)

Matrix leadership

Education

Master’s degree or higher (life sciences/medicine/pharmacology)

Medical degree or PhD in life/pharmacology

Tools

Clinical trial management systems

eTMF

Study dashboards/tools

Job description

IQVIA is seeking a Clinical Trial Leader/Senior Clinical Trial Leader to drive end-to-end Phase I Healthy Volunteer studies within Clinical FSP. You will steer study design, protocol development, and cross-functional execution, aligning medical and pharmacology partners to deliver high-quality, timely trials.

You will lead interdisciplinary teams, manage safety and data interpretation, and maintain governance through transparent communication and risk-based planning.