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 10 years of relevant ex