Job Posting Title- Clinical Trial LeadLocation: Home-based in the U.S. Responsibilities & Key Tasks• 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.
• 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, CMR (cardiovascular-metabolic renal)) and apply clinical pharmacology knowledge to study design and execution.
• Maintain fluency in English, with effective communication and leadership capabilities.
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE• Master's or higher-level degree in life sciences or related field. An education as a physician would be a plus.
• Minimum of 5 years (or 10 years for Senior CTL role) of global clinical operations management experience, preferable within a global CRO environment.
• Experience in set-up and conduct of Phase III clinical trials including in depth knowledge study designs, and protocol writing.
• Knowledge of applicable clinical research regulatory requirements e.g. GCP / ICH guidelines, CTR and relevant local laws.
• Therapeutic area knowledge in oncology, inflammatory or CMR would be required and experience in any of the following would be an advantage: respiratory, CNS, ophthalmology.
• Computer skills including good knowledge of Microsoft Word, Excel and PowerPoint.
• Fluent language skills in English.
• Effective communication, organizational and problem-solving skills.
• Strong leadership competencies and ability to establish and maintain effective working relationships.
Required Qualifications & Competencies• Education: Master's degree or higher in life sciences or a related field is required; medical education (e.g., physician) is considered a strong asset.
• Experience: 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.
• Clinical Expertise: Proven experience in the setup and conduct of Phase III clinical trials, with deep knowledge of study designs, protocol development. Further experience in Phase II trials is considered beneficial.
• Regulatory Knowledge: Strong understanding and practical application of clinical research regulatory requirements, including GCP, ICH guidelines, and relevant local laws.
• Therapeutic Area Knowledge: Familiarity with therapeutic areas such as oncology, inflammatory, CMR
• Leadership & People Management: Demonstrated ability to lead and manage global clinical teams in a matrix structure, delegate effectively, provide coaching and feedback.
• Collaboration & Communication: Excellent interpersonal and communication skills, with the ability to work across geographies and cultures, and build strong relationships with internal and external stakeholders.
• Organizational Skills: Strong planning, organizational, and problem-solving abilities, with a proven track record of managing competing priorities and delivering results to quality and timeline metrics.
• Customer Focus & Decision-Making: Ability to understand customer needs, navigate complex discussions, and negotiate effective solutions. Demonstrates sound judgment and decision-making capabilities.
• Learning Agility: Committed to continuous learning and development, with openness to evolving industry practices and technologies.
• Technical Proficiency: Strong computer skills, including proficiency in Microsoft Word, Excel, PowerPoint, and clinical trial management systems.
• Language Skills: Fluent in English.
• Core Competencies: Demonstrates key competencies such as Client Focus, Collaboration, Communication, Innovation, and Ownership.
- 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 and time management
- Maintaining a logical and organized approach to execution
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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 a number of factors including 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.
