Early Clinical Scientist- Translational Medicine -FSP

About the role

The Early Clinical Scientist/ECS coordinates the design, planning and execution of early‑phase clinical trials with the Clinical Director and internal/external team members. The role oversees trials across programs or therapeutic areas, ensures compliance and data validity, manages team performance, conducts safety assessments, and provides real‑time oversight to mitigate study issues. The scientist also contributes to technical writing, develops operational documents, and leads project management activities under accelerated timelines.

Responsibilities

• Coordinates the design, planning and execution of early‑phase clinical trials with the Clinical Director and internal/external team members.
• Oversees trials within and/or across programs/therapeutic areas, ensuring excellence in execution and compliance to support study objectives and data validity.
• Manages internal and external team performance to achieve project objectives and resolves performance issues as they arise.
• Ensures appropriate clinical safety assessment and risk management of compounds.
• Conducts real‑time oversight of ongoing trials to identify and mitigate patient, study design, data, or conduct issues.
• Reviews and interprets clinical trial data.
• May conduct on‑site study monitoring, including site training and supervision of complex, novel endpoint/biomarker collection processes.
• Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
• Co‑authors clinical sections of protocols, investigator brochures, and clinical study reports, ensuring documents meet applicable standards.
• Develops study operational documents (e.g., site monitoring plan, study operations manual, informed consent).
• Manages trial and program projects, including meetings, document and collaborative workspace management, risk assessment and contingency planning under accelerated timelines.
• Builds knowledge of early drug development processes and expands skills to manage additional processes and procedures.

Required Experience and Skills

• Experience managing CROs from the sponsor side for Phase 1 clinical trials.
• Proficiency with Clinical Trial Management Systems and Trial Master File systems.
• Authoring protocol concepts and related clinical documents.
• Facilitating trial teams that include cross‑functional partners such as regulatory, clinical supplies, data management, statistics, programming, procurement, etc.
• Ability to manage multiple projects simultaneously.
• Reviewing protocols, informed consent forms, investigator brochures, clinical study reports, biomarker processes, site and medical monitoring plans, risk assessments, and protocol deviations.
• Proficiency with Microsoft Teams.
• Understanding of the clinical research development process from program planning to regulatory submission.
• Rapidly develop scientific knowledge across therapeutic areas.
• Manage complex operations and projects under accelerated timelines.
• Scientific, medical, or safety writing and reporting (at least one required).
• Effective partnership with internal and external teams to achieve results.
• Strong team collaboration, leadership, written and verbal communication, issue identification and resolution skills.
• Knowledge of GCP, ICH guidelines and regulatory requirements.

Education

• Bachelor’s degree in Life Sciences with ≥7 years related experience, OR
• Master’s degree in Life Sciences with ≥5 years related experience, OR
• PhD or doctorate degree with ≥1 year related experience (e.g., clinical trial management, site training/monitoring, medical and regulatory writing), OR
• Equivalent experience developing pre‑clinical model experiments for drug candidates (protocol authoring, experiment execution/oversight, authoring experiment reports).