Senior Scientist, Clinical Research

Early Clinical Scientist (ECS) coordinates the design, planning, and execution of early phase clinical trials with the Clinical Director and internal/external teams. Oversees trials within/across programs/therapeutic areas to ensure excellent execution and compliance supporting study objectives and data validity. Manages internal/external team performance, resolves performance issues, and ensures appropriate clinical safety assessment and risk management. Provides real-time oversight of ongoing trials to identify/mitigate patient, study design, data, or conduct issues; reviews and 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; develops/improves job aids/SOPs/procedures and promotes best practices. Technical writing: Co-authors protocols, investigator brochures, clinical study reports, WMA/CTD sections, safety reports, clinical development plans, publications, and abstracts; develops study operational documents. Project management: Manages trial/program projects; meetings and document workspace management; risk assessment and contingency planning under accelerated timelines. Education: Degree in Life Sciences; Bachelor’s +6 years, or Master’s +4 years, or PhD/doctorate +2 years (clinical trial management/execution; site training/monitoring; medical/regulatory writing). Required: 3+ years operational clinical scientist/study manager in pharma/biotech; clinical research development process knowledge (program planning to regulatory submission); ability to learn therapeutic areas quickly; manage complex projects under accelerated timelines; scientific/medical/safety writing & reporting (at least one); partner with internal/external teams; collaboration/leadership/communication; GCP/ICH/regulatory knowledge. Preferred: Global Phase I trials/safety reporting/WMA submission; Immunology and/or vaccine trial experience. Salary range: $117,000.00–$184,200.00; annual bonus/long-term incentive if applicable. Benefits include medical/dental/vision, 401(k), paid holidays, vacation, and sick/compassionate days. #J-18808-Ljbffr