Description
The IQVIA Clinical Functional Service Partnerships (Clinical FSP) department provides highly skilled professionals who work as integrated members of 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.
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.
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.
- Guide dose escalation and data-informed decisions: Support dose-escalation strategy and decision-making by integrating emerging safety, tolerability, PK and PD information.
- Develop core trial plans and documents: Author or coordinate study protocols, and other essential trial documents.
- 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.
- Drive governance and trial communication: Serve as the primary trial contact for progress, risks and governance.
- Manage safety, risk, issues and escalation: Anticipate trial risks, assess impact, define risk-balanced mitigation.
- Create cross-functional alignment: Translate scientific, medical, statistical, regulatory, safety, PK/PD, biosampling and operational requirements into clear actions.
- Oversee delivery partners: Maintain effective oversight of clinical Phase I units, CROs, laboratories, vendors and outsourced services.
- Maintain quality and compliance: Ensure adherence to GCP, ICH, applicable global and local regulations.
- Use data to steer performance: Use study systems, dashboards, metrics and operational reviews to monitor study progress.
- Support critical outputs and early-development strategy: Coordinate cross-functional contributions to authority and ethics responses.
What you bring
- Essential: Recent Phase I Healthy Volunteer leadership: Strong, current or recent experience leading the set-up and conduct of Phase I Healthy Volunteer clinical trials.
- Essential: Early phase study-design expertise: In-depth knowledge of early phase study designs, protocol writing and clinical pharmacology.
- Essential: Scientific contribution: Demonstrated ability to contribute to study design, dose-escalation strategy, safety assessment and interpretation of PK/PD information.
- Essential: End-to-end ownership: Accountability across study preparation, set-up, initiation, conduct, close-out, reporting.
- Leadership in a matrix: Ability to inspire high-performing interdisciplinary teams.
- Risk-based delivery mindset: Proactive risk management, sound judgement.
- Communication excellence: Clear, concise and audience-aware communication.
- Regulatory knowledge: Strong working knowledge of GCP, ICH guidelines.
- Education: A Master's degree or higher in life sciences, medicine, pharmacy, pharmacology or a related discipline is preferred.
- Language and technology: Fluent English and confidence using clinical trial management systems.