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

IQVIA Inc; Frankfurt; Vor Ort; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Clinical Trial Leader / Senior Clinical Trial Leader in Frankfurt to drive end-to-end delivery of Phase I Healthy Volunteer studies. You will lead core and extended teams, translate early development strategies into executable plans, and ensure safety, quality and timely study delivery.

You will contribute to study design, risk assessment and cross-functional collaboration with medical, pharmacology and operations partners to optimize outcomes and governance processes.

Qualifikationen

• Recent Phase I Healthy Volunteer leadership with end-to-end accountability.
• Strong expertise in early phase study design, protocol writing and clinical pharmacology.
• Ability to interpret PK/PD data and support dose-escalation decisions.
• Experience coordinating cross-functional teams across medical, clinical operations and governance.

Aufgaben

• Lead and deliver complex Phase I HV studies from prep to reporting.
• Guide protocol strategy with cross-functional partners to ensure feasibility.
• Support dose-escalation decisions and safety reviews with medical stakeholders.
• Develop core trial plans, TMF and essential study documentation.
• Plan site/Vendor delivery and study timelines with governance oversight.
• Ensure regulatory and quality compliance across the trial lifecycle.
• Communicate progress, risks and decisions to stakeholders and sponsors.

Kenntnisse

Phase I HV leadership

Early phase study-design

Protocol design

End-to-end ownership

Matrix leadership

Risk-based delivery

Communication skills

Regulatory knowledge

Fluent English

Ausbildung

Master’s degree or higher in life sciences

MD/PhD in related field asset

Jobbeschreibung

Frankfurt, Hesse, Germany

Amsterdam, Netherlands

Vienna, Austria

Full time

R1571062

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 upscale 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 procedures and inspection-ready documentation throughout the trial lifecycle. Ensure consistent use of study tools, training materials and standard processes.

Use data to steer performance: Use study systems, dashboards, metrics and operational reviews to monitor study progress, safety and data flows, identify trends, support timely data cleaning and protect milestone achievement.

Support critical outputs and early-development strategy: Coordinate cross-functional contributions to authority and ethics responses, safety reviews, data monitoring, clinical trial reporting, TMF completeness, registry disclosure and publication support. Provide strategic input to early clinical development and support RFI/RFP and bid-defence activities where required.

I mprove how we work: Contribute to process optimization, lessons learned, cross-functional initiatives and adoption of relevant technology and practices across early clinical development.

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, with demonstrated end-to-end accountability.

• Essential: Early phase study-design expertise: In-depth knowledge of early phase study designs, protocol writing and clinical pharmacology. Experience should include several relevant study types, such as first-in-human, single- or multiple-ascending-dose, PK/PD, BA/BE, DDI and food-effect studies.

• Essential: Scientific contribution: Demonstrated ability to contribute to study design, dose-escalation strategy, safety assessment and interpretation of PK/PD information with medical, clinical pharmacology and statistical partners.

• Essential: End-to-end ownership: Accountability across study preparation, set-up, initiation, conduct, close-out, reporting, governance, documentation, quality and delivery outcomes.

• Leadership in a matrix: Ability to inspire high-performing interdisciplinary teams, influence without relying on hierarchy, manage conflict and navigate complex sponsor, CRO, clinical-unit and vendor interfaces.

• Risk-based delivery mindset: Proactive risk management, sound judgement, structured problem-solving, clear escalation and a strong focus on participant safety, quality, timelines and value.

• Communication excellence: Clear, concise and audience-aware communication; active listening; cultural awareness; and confidence presenting complex scientific and operational topics and recommendations.

• Regulatory knowledge : Strong working knowledge of GCP, ICH guidelines, applicable clinical-trial regulations, SOPs and relevant global and local requirements.

• Education: A Master’s degree or higher in life sciences, medicine, pharmacy, pharmacology or a related discipline is preferred. A medical degree or PhD in life or natural sciences and/or pharmacology is considered an asset. An equivalent combination of education and highly relevant experience may also be considered.

• Language and technology: Fluent English and confidence using clinical trial management systems, eTMF and study tools, dashboards, Microsoft Office applications and data-driven oversight approaches.

Relevant scientific and operational background

• Experience with a range of Phase I Healthy Volunteer designs, ideally including first-in-human, SAD/MAD, PK/PD, BA/BE, DDI and food-effect studies.

• Experience with clinical-unit delivery, cohort scheduling, sentinel or staggered dosing approaches, intensive safety surveillance and time-critical sample or data flows is advantageous.

• Therapeutic-area exposure in oncology, inflammatory diseases, cardiovascular, renal and metabolic indications, or other relevant development areas is an advantage.

• Experience supporting inspection readiness, vendor oversight, financial management, RFI/RFP activity or bid defense is beneficial.

If you enjoy taking full ownership of scientifically demanding early phase trials, bringing interdisciplinary teams together around a clear plan, and combining participant-safety focus with disciplined operational delivery, we would be pleased to hear from you.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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