Senior Scientist, Clinical Research

Early Clinical Scientist (ECS)

Responsibilities

• Coordinate design, planning, and execution of early phase clinical trials with Clinical Director and internal/external teams; oversee trials within/across programs/therapeutic areas to ensure execution/compliance, study objectives, and data validity.
• Manage internal/external team performance; resolve project performance issues.
• Ensure clinical safety assessment and risk management; provide real-time oversight to identify/mitigate patient, study design, data, or conduct issues.
• Review and interpret clinical trial data; may conduct on-site monitoring, including site training and supervision of complex/novel endpoint or biomarker collection.
• Apply GCP, ICH, and regulatory requirements for clinical development.
• Represent Early Stage Development on cross-functional teams; develop/improve job aids/SOPs/procedures and promote adoption.
• Co-author clinical documents (protocols, investigator brochures, clinical study reports, WMA/CTD sections, safety/agency updates), and develop study operational documents (e.g., monitoring plan, study operations manual, informed consent).
• Manage trial/program projects, team activities, and risk/contingency planning under accelerated timelines.

Education

• Degree in Life Sciences; or Bachelor's + 6 years, Master's + 4 years, or PhD/doctorate + 2 years (clinical trial management/execution; site training/monitoring; medical/regulatory writing).

Required Skills/Experience

• 3+ years as operational clinical scientist or study manager in pharma/biotech clinical research.
• Knowledge from program planning through regulatory submission; ability to learn therapeutic areas quickly.
• Manage complex operations under accelerated timelines.
• Scientific/medical/safety writing and reporting (at least one).
• Partner with internal/external teams; strong collaboration/leadership/communication/issue resolution.
• Knowledge of GCP, ICH, and regulatory requirements.

Preferred

• Global Phase I trials, safety reporting, and regulatory WMA submission experience.
• Immunology and/or vaccine trial experience.