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.