Early Clinical Scientist- Translational Medicine -FSP

Accountabilities:: Coordinate the design, planning, and execution of early-phase clinical trials in partnership with Clinical Directors and internal and external stakeholders. Oversee clinical trials within and across programs or therapeutic areas, ensuring high standards of execution, compliance, and data validity. Manage internal and external team performance and address project performance issues to support successful study delivery. Conduct appropriate clinical safety assessments and contribute to compound risk management activities. Provide real-time oversight of ongoing studies to identify and mitigate patient, study design, data quality, and study conduct risks. Review and interpret clinical trial data to support informed clinical and operational decisions. Conduct on-site study monitoring when required, including site training and supervision of complex or novel endpoint and biomarker collection processes. Apply GCP, ICH guidelines, and applicable regulatory requirements throughout clinical development activities. Co-author clinical sections of protocols, clinical investigator brochures, and clinical study reports in accordance with applicable standards. Develop study operational documents such as site monitoring plans, study operations manuals, informed consent documents, and related materials. Manage trial and program activities, including meetings, documentation, collaborative workspaces, and cross-functional coordination. Perform project risk assessments and develop contingency plans to address potential delivery challenges under accelerated timelines. Build knowledge and capability across early drug development processes, procedures, and therapeutic areas. Coordinate effectively with regulatory, clinical supplies, data management, statistics, programming, procurement, and other functional partners. Requirements Degree in Life Sciences. Bachelor’s degree with at least 7 years of related experience, or master’s degree with at least 5 years of related experience, or PhD/doctorate with at least 1 year of related experience. Experience managing CROs from the sponsor side for Phase 1 clinical trials. Experience using Clinical Trial Management Systems and Trial Master File systems. Experience authoring protocol concepts and reviewing key clinical documents. Experience facilitating cross-functional trial teams involving regulatory, clinical supplies, data management, statistics, programming, procurement, and other functions. Ability to manage multiple projects simultaneously while maintaining quality and timelines. Experience reviewing protocols, informed consent forms, investigator brochures, clinical study reports, biomarker processes, site and medical monitoring plans, risk assessments, and protocol deviations. Understanding of the clinical research and drug development process from program planning through regulatory submission. Ability to rapidly develop working scientific knowledge across different therapeutic areas. Demonstrated ability to manage complex clinical operations and projects under accelerated timelines. Experience in at least one area of scientific, medical, or safety writing and reporting. Strong understanding of GCP, ICH guidelines, and regulatory requirements. Strong written and verbal communication, leadership, collaboration, issue identification, and problem-solving skills. Ability to build effective partnerships with internal and external teams to achieve project objectives. Experience working with Microsoft Teams. Related experience may include clinical trial management and execution, clinical site training and monitoring, medical or regulatory writing, or equivalent experience developing preclinical model experiments for drug candidates. Benefits Remote work opportunity within the United States. Opportunity to contribute to early-phase clinical development and translational medicine programs. Exposure to multiple therapeutic areas and early drug development processes. Cross-functional collaboration with clinical, regulatory, data, statistical, programming, supply, and other specialized teams. Opportunity to work on complex clinical programs involving novel endpoints and biomarker collection processes. Broad scope spanning clinical trial planning, execution, safety, risk management, scientific writing, and project management. Opportunity to develop expertise across clinical development, operational processes, and regulatory requirements.