As Clinical Trial Leader (m/w/d) you will be accountable for the operational performance of the trial (preparation, initiation, conduct, close-out and reporting). As such you will manage cross-functional trial teams at the customer, acting as that accountable point for delivery and quality whilst maintaining financial control. You will be supported by domain experts in every function, enabled by best-in-class technology and data analytics.

1. Role purpose

As Clinical Trial Leader, you will act as the primary driver of study execution and be accountable for the operational performance of assigned clinical trials across preparation, initiation, conduct, close-out, and reporting. You will lead global, cross-functional trial teams and be accountable for delivery, quality, compliance, timelines, risk management, and financial oversight.

The role requires a highly experienced global clinical operations leader with strong Phase III and end-to-end trial delivery experience, and proven capability to drive protocol development in partnership with medical, statistical, and cross-functional stakeholders. You will translate complex scientific, medical, statistical, and operational requirements into executable trial delivery plans and provide leadership throughout the trial lifecycle.

Success in this role requires the ability to rapidly integrate into ongoing programs, create clarity in complex matrix environments, proactively identify and manage risks, escalate issues appropriately, resolve conflict constructively, and maintain strong stakeholder communication and alignment. The Clinical Trial Leader is expected to operate with a high degree of independence, ensuring study objectives are delivered while protecting quality, compliance, timelines, and budget control.

2. Key accountabilities and responsibilities

• Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III clinical trials with accountability for timelines, quality, budget awareness, and operational execution.

• Drive protocol development together with medical, statistical, and cross-functional stakeholders, ensuring operational feasibility, implementation readiness, and translation of protocol requirements into clear study execution plans.

• Lead end-to-end trial delivery independently, covering study preparation, setup, initiation, conduct, close-out, reporting, governance, documentation, and performance oversight.

• Act as the primary driver of study execution and the main operational point of contact for trial progress at global level, governance, issue resolution, risk management, and escalation.

• Provide leadership to interdisciplinary core trial teams, including local/regional clinical operations functions, data management, statistics, pharmacokinetics, safety, medical, and other relevant functions.

• Facilitate effective trial governance, including Trial Oversight Meetings and other relevant forums, ensuring clear decisions, actions, ownership, and follow-up.

• Author study plans, tools, training materials, quality plans, risk management plans and other operational documentation and ensure are fit for purpose and consistently implemented.

• Monitor trial progress using dashboards, metrics, system data, and operational reviews to ensure timely and accurate reporting, system compliance, and milestone achievement.

• Manage study risks and quality issues proactively, including risk identification, impact assessment, mitigation planning, communication, escalation, and corrective or preventive action tracking.

• Work effectively within complex matrix organizations across functions, geographies, cultures, and external partner interfaces.

• Support continuous improvement by contributing to process optimization, cross-functional initiatives, and adoption of relevant technology, tools, and practices.

3. Candidate profile and required experience

• Extensive experience leading Phase III clinical trials, with demonstrated ability to quickly integrate into ongoing programs.

• Proven capability to drive protocol development in collaboration with medical, statistical, and cross-functional stakeholders.

• Ability to challenge assumptions constructively during protocol and trial design discussions, balancing scientific objectives with operational feasibility and execution realities.

• End-to-end clinical trial leadership experience, including study setup, conduct, reporting, documentation, governance, and vendor or stakeholder coordination.

• Extensive clinical operations experience with clear evidence of independent trial leadership and accountability for delivery outcomes.

• Minimum 10 years of relevant clinical research experience, including at least 5 years in global clinical trial management, preferably within a global CRO or pharmaceutical environment.

• Experience leading clinical teams in a matrix structure with the ability to influence without relying solely on hierarchical authority.

• Strong knowledge of clinical research regulatory requirements, including GCP, ICH guidelines, CTR, SOPs, and applicable local requirements.

• Master’s degree or higher in life sciences or a related field; medical education or equivalent scientific background is an advantage.

4. Core competencies

• Leadership & influence: Inspires cross-functional teams around a common goal, translates complex situations into actionable components, and influences stakeholders and management to resolve challenges.

• Protocol and operational design leadership: Drives protocol development discussions, understands operational feasibility, and converts complex trial requirements into practical delivery plans.

• Communication: Displays excellent communication and stakeholder management skills adapts communication style to the audience, demonstrates active listening and cultural awareness, and communicates risks, decisions, and expectations clearly.

• Project management: Plans effectively, sets clear expectations, realistic timelines and priorities, and defines actions, maintains a logical and organized execution approach and makes appropriate use of resources.

• Risk and issue management: Anticipates risks, identifies issues early, proactively develops risk-balanced solutions, and escalates appropriately when needed.

• Conflict management and resilience: Manages conflict and difficult situations constructively, works under pressure, and navigates challenging stakeholder discussions with maturity.

• Matrix collaboration: Works effectively across functions, countries, cultures, customer stakeholders, and partner interfaces within complex organizational structures.

5. Preferred therapeutic and operational background

• Experience in oncology, inflammatory, and/or cardiovascular-metabolic-renal therapeutic areas is required.

• Experience with additional therapeutic areas (e.g., respiratory, ophthalmology) or new indications is valuable where the candidate demonstrates adaptability and strong underlying clinical operations leadership.

• Strong computer skills, including Microsoft Word, Excel, PowerPoint, and relevant clinical trial management systems or study tools.

Please apply with your English CV.