(Senior) Clinical Trial Lead (m/w/d)
Core
Lead end-to-end execution of complex Phase I Healthy Volunteer clinical trials, translating early-development strategy into safe, high-quality study delivery.
Role type
Senior Clinical Trial Lead (Phase I)
Builds
Phase I clinical studies for early clinical development
Domain
Clinical Research / Early Phase Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Phase I Healthy Volunteer trial leadership, early phase study design, protocol authoring, clinical pharmacology, dose-escalation strategy, safety and PK/PD data interpretation, cross-functional team alignment, vendor and clinical unit oversight, GCP and regulatory compliance, risk management
Preferred skills
Experience with first-in-human, single/multiple ascending-dose, PK/PD, BA/BE, DDI, and food-effect studies
Technologies
Clinical trial management systems, study tools, dashboards
Responsibilities
Lead interdisciplinary teams for Phase I trial preparation, set-up, initiation, conduct, close-out, and reporting; Contribute to study design, protocol development, and dose-escalation strategy; Author or coordinate study protocols and essential trial documents; Plan clinical-unit selection, recruitment, and vendor delivery; Drive governance, risk management, and safety oversight; Ensure adherence to GCP and global/local regulations; Use data and metrics to monitor study progress and performance
Seniority
Senior, hands-on IC
