(Senior) Clinical Trial Lead (m/w/d)
Core
Lead end-to-end delivery of complex Phase I Healthy Volunteer clinical trials, serving as the central point of accountability for study success, safety, quality, and financial control while translating early-development strategy into operational plans.
Role type
Senior Clinical Trial Lead (Phase I)
Builds
Phase I clinical studies for pharmaceutical sponsors
Domain
Clinical Research / Early Phase Drug Development
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 CRO oversight, GCP/ICH compliance, risk management
Preferred skills
Experience with first-in-human, single/multiple ascending-dose, PK/PD, BA/BE, DDI, and food-effect studies; ability to influence without hierarchy; process optimization
Technologies
Clinical trial management systems, dashboards, study tools
Responsibilities
Lead interdisciplinary teams through the full trial lifecycle from preparation to reporting; contribute to study design and protocol development; guide dose-escalation and safety decisions; author trial documents and plans; manage clinical units, sites, and vendors; drive governance and communication; manage safety risks and issues; ensure quality and regulatory compliance; use data to monitor performance; support early-development strategy and bid-defense activities.
Seniority
Senior, hands-on IC with leadership accountability