(Senior) Clinical Trial Lead (m/w/d)

The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department provides highly skilled professionals who work as integrated members of our client’s clinical development teams. In this sponsor-dedicated role, you will combine end-to-end operational leadership with strong scientific ownership across early phase clinical research, supported by experienced specialists, technology and data-driven insights. We are looking for a Clinical Trial Leader / Senior Clinical Trial Leader who can take clear accountability for complex Phase I Healthy Volunteer trials, lead interdisciplinary teams, and translate early-development strategy into safe, high-quality and timely study delivery. (Senior) Clinical Trial Leader This opportunity is especially suited to you if you: currently lead, or have recently led, Phase I Healthy Volunteer trials with end-to-end accountability; bring strong knowledge of early phase study designs, protocol authoring and clinical pharmacology; can contribute credibly to dose-escalation strategy and the interpretation of safety and PK/PD data; are comfortable making or shaping scientific and operational decisions in close alignment with medical and clinical pharmacology partners; can create alignment across interdisciplinary teams, governance forums, clinical units and external delivery partners. Your role and impact As Clinical Trial Leader / Senior Clinical Trial Leader , you will provide leadership and direction to the core and extended trial team and serve as the central point of accountability for the end-to-end success and delivery of assigned Phase I Healthy Volunteer trials. You will independently steer preparation, set-up, initiation, conduct, close-out and reporting, ensuring that scientific objectives are translated into operationally feasible plans and delivered to defined milestones, quality expectations and financial parameters. Beyond operational execution, you will act as a scientifically credible early-development partner. You will contribute to study design and protocol development, support dose-escalation and other key trial decisions, integrate emerging safety and PK/PD information, anticipate risks, and drive timely escalation and resolution. For non-medical trial leaders, medical decisions will be taken in alignment with the responsible medical stakeholders. What will make you successful in this role Recent hands-on leadership of diverse and complex Healthy Volunteer studies, with end-to-end accountability and strong understanding of early phase execution. Clear ownership for trial success, participant safety, quality, milestones and financial control, with sound judgement under pressure. Strong command of protocol design, dose escalation, safety evaluation and PK/PD concepts, with confidence to challenge assumptions constructively. Ability to align clinical pharmacology, medical, statistics, pharmacokinetics, biosampling, data management, clinical operations, procurement, vendors and governance stakeholders. Key accountabilities Lead and deliver: Provide direction to interdisciplinary trial teams and independently lead complex Phase I Healthy Volunteer studies from preparation through reporting, with accountability for participant safety, quality, milestones, timelines, operational execution and financial control. Shape study design and protocol strategy: Drive or substantially contribute to protocol and protocol synopsis development with clinical pharmacology, medical, statistical, pharmacokinetic and cross-functional partners. Ensure the design is scientifically robust, ethically appropriate, operationally feasible and implementation-ready. Guide dose escalation and data-informed decisions: Support dose-escalation strategy and decision-making by integrating emerging safety, tolerability, PK and PD information. Prepare clear recommendations and enable timely decisions through the applicable governance and medical oversight framework. Develop core trial plans and documents: Author or coordinate study protocols, and other essential trial documents, including informed consent materials, integrated quality plans, amendments, training materials and other study-specific documentation. Plan clinical-unit and vendor delivery: Lead feasibility, clinical-unit or site selection input, recruitment and cohort planning, study schedule development, vendor strategy, supply and biosampling dependencies, and alignment of internal and external delivery activities. Drive governance and trial communication: Serve as the primary trial contact for progress, risks and governance. Lead trial oversight meetings as applicable, communicate status transparently, and secure timely, well-informed decisions from stakeholders and decision-making forums. Manage safety, risk, issues and escalation: Anticipate trial risks, assess impact, define risk-balanced mitigation, track corrective actions and escalate with appropriate timing, context and proposed solutions. Collaborate with medical and pharmacogenetics experts on preclinical, medical and safety considerations, including SAEs and SUSARs. Create cross-functional alignment: Translate scientific, medical, statistical, regulatory, safety, PK/PD, biosampling and operational requirements into clear actions, ownership, priorities and realistic timelines for the core and extended team. Oversee delivery partners: Maintain effective oversight of clinical Phase I units, CROs, laboratories, vendors and outsourced services, including scope, performance, quality, dependencies, financials and issue resolution in collaboration with accountable functions. Maintain quality and compliance: Ensure adherence to GCP, ICH, applicable global and local regulations, sponsor p