Lead, Phase I Clinical Trials

IQVIA; Wien; Vor Ort; EUR 90.000 - 140.000; Vollzeit

Zusammenfassung

IQVIA Clinical FSP seeks a Clinical Trial Leader to drive end-to-end Phase I Healthy Volunteer studies, translating early development strategy into safe, timely study delivery. You will lead interdisciplinary teams and act as the central point of accountability for trial success.

Beyond execution, you will contribute to study design, support dose escalation decisions, and integrate safety and PK/PD data with medical partners, ensuring governance and high-quality outcomes.

Qualifikationen

• Recent Phase I Healthy Volunteer leadership with end-to-end accountability.
• Strong protocol design and clinical pharmacology knowledge.
• Ability to interpret PK/PD data and support dose escalation.
• Translate scientific and operational decisions with medical partners.
• Experience aligning multidisciplinary teams and governance forums.

Aufgaben

• Provide direction to interdisciplinary trial teams and lead complex Phase I HV studies with accountability.
• Drive protocol design, synopsis development and robust operational plans.
• Support dose-escalation decisions using safety, PK/PD data and governance input.
• Coordinate study documents, informed consent materials and quality plans.
• Oversee vendor delivery, unit selection, scheduling and risk mitigation.
• Maintain GCP/ICH compliance and inspection readiness throughout the trial lifecycle.
• Use dashboards and metrics to monitor progress, safety and data quality.
• Contribute to early development strategy and regulatory responses when needed.

Kenntnisse

Phase I leadership

Healthy Volunteer trials

Protocol design

Clinical pharmacology

Dose escalation

Data interpretation

GCP/ICH knowledge

Cross-functional leadership

Risk management

Stakeholder management

Ausbildung

Master’s degree or higher in life sciences / related

Medical degree or PhD asset

Tools

CTMS

eTMF

Study tools / dashboards

Jobbeschreibung

IQVIA Clinical FSP seeks a Clinical Trial Leader to drive end-to-end Phase I Healthy Volunteer studies, translating early development strategy into safe, timely study delivery. You will lead interdisciplinary teams and act as the central point of accountability for trial success.

Beyond execution, you will contribute to study design, support dose escalation decisions, and integrate safety and PK/PD data with medical partners, ensuring governance and high-quality outcomes.