Clinical Trial Lead

Job Posting Title- Clinical Trial Lead Location: 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