Clinical Trial Lead

Location: Home-based in the U.S.

About the role

Lead global, cross-functional trial teams to ensure successful delivery of complex Phase III studies, with accountability for timelines, quality, and strategic oversight. Serve as the primary contact for internal and external stakeholders regarding trial progress, governance, and issue resolution.

Responsibilities

• Author and manage essential trial documentation including protocols, informed consent forms (ICFs), study management plans, and integrated quality plans.
• Provide strategic input and make scientific or medical decisions in early clinical development, in alignment with medical colleagues when applicable.
• Ensure consistent use of study tools, training materials, and adherence to GCP/ICH guidelines, SOPs, and regulatory requirements.
• Lead interdisciplinary core trial teams (e.g., data management, statistics, pharmacokinetics, clinical operations) and facilitate Trial Oversight Meetings.
• Collaborate cross-functionally to support milestone achievement and proactively manage study risks and mitigation strategies.
• Manage and mentor clinical operations staff, including performance appraisals, development planning, and resolution of employee relations issues.
• Provide coaching on project planning, risk management, and problem-solving to ensure global alignment and adoption of process and technology tools.
• Support staff in achieving project deliverables on time and within budget, ensuring quality and compliance with contractual obligations.
• Monitor and guide financial aspects of trials including scope, budget, schedule, and change control.
• Conduct regular performance reviews using dashboards and metrics, ensuring accurate reporting and system compliance.
• Plan trial quality and risk monitoring/mitigation.
• Identify and address quality issues within studies, implementing corrective and preventive actions as needed.
• Perform continuous review, risk identification, evaluation/analysis, and communication on a trial level as applicable.
• Lead or contribute to corporate initiatives, process improvements, and cross-functional collaborations.
• Train and support staff on clinical trial processes, systems, and competency frameworks to foster continuous development.
• Consult with pharmacogenetics and safety experts on preclinical data, adverse events (SAEs, SUSARs), and side effect profiles as needed.
• Demonstrate therapeutic area expertise (e.g., oncology, inflammatory, cardiovascular-metabolic renal) and apply clinical pharmacology knowledge to study design and execution.
• Maintain fluency in English, with effective communication and leadership capabilities.

Requirements

• Master’s or higher-level degree in life sciences or related field; medical education (e.g., physician) is a strong asset.
• Minimum of 10 years of relevant experience in clinical research, including at least 5 years in global clinical operations and trial management with leading a clinical team in a matrix structure, preferably within a global CRO or pharmaceutical environment.
• Proven experience in the setup and conduct of Phase III clinical trials, with deep knowledge of study designs and protocol development; Phase II experience is beneficial.
• Strong understanding and practical application of clinical research regulatory requirements, including GCP, ICH guidelines, and relevant local laws.
• Therapeutic area knowledge in oncology, inflammatory, or cardiovascular-metabolic renal; experience in respiratory, CNS, or ophthalmology is an advantage.
• Extensive experience leading late-stage clinical trials (Phase III) and the ability to quickly integrate into ongoing programs.
• Demonstrated ability to appropriately identify and escalate issues when needed.
• Strong proactive risk management skills.
• Proven capability to effectively manage conflict and navigate challenging situations.
• Experience working within and successfully navigating complex matrix organizations.
• Excellent communication and stakeholder management skills.
• Strong project management capabilities, including defining clear expectations, establishing realistic timelines, effective prioritization, time management, and maintaining a logical and organized approach to execution.
• Proficiency in Microsoft Word, Excel, PowerPoint, and clinical trial management systems.
• Fluent in English.

Skills

• Client Focus
• Collaboration
• Communication
• Innovation
• Ownership
• Leadership & People Management
• Organizational and problem-solving abilities
• Customer focus & decision-making
• Learning agility

Pay

The potential base pay range for this role, when annualized, is $93,100.00 - $232,800.00. The actual base pay offered may vary based on job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.