Early Clinical Scientist (ECS) coordinates design, planning, and execution of early-phase clinical trials with the Clinical Director and internal/external teams. Oversees trials across programs/therapeutic areas to ensure excellence in execution/compliance supporting study objectives and data validity. Manages internal/external team performance; resolves performance issues as needed.
Ensures clinical safety assessment and compound risk management. Provides real-time oversight of ongoing trials to identify/mitigate patient, study design, data, and conduct issues. Reviews/interprets clinical trial data; may conduct on-site monitoring, including site training and supervision of novel endpoint/biomarker collection. Applies GCP, ICH, and regulatory requirements.
Represents Early Stage Development on cross-functional teams to develop/improve SOPs/job aids and share best practices.
Co-authors clinical protocol, investigator brochure, clinical study report, WMA/CTD sections, regulatory update/safety reports, development plans, publications, and abstracts; develops study operational documents.
Manages trial/program projects, meetings, documentation/workspaces, and performs risk assessment/contingency planning under accelerated timelines.
Education/Experience: Degree in Life Sciences; Bachelorβs +6 yrs, or Masterβs +4 yrs, or PhD/doctorate +2 yrs (clinical trial management/execution; site training/monitoring; medical/regulatory writing).
Required: 3+ years as operational clinical scientist or study manager in pharma/biotech; knowledge from program planning to regulatory submission; ability to learn therapeutic areas quickly; manage complex work on accelerated timelines; scientific/medical/safety writing (at least one); partner effectively; collaboration/leadership/communication; GCP/ICH/regulatory knowledge.
Preferred: Global Phase I and WMA submission experience; Immunology/vaccine trials experience.
Skills: clinical development/research, clinical study management, trial planning/analysis, drug development, regulatory submissions/writing, risk assessments, ethical compliance.