General Summary:

The Sr. Clinical Scientist will be responsible for designing clinical trials, contributing to data cleaning and analysis, contributing to regulatory submissions, collaborating with internal and external stakeholders, and providing scientific leadership.

Job Duties and Responsibilities: 

• Design clinical trials: Propose and ensure study designs are scientifically sound, feasible, and aligned with the clinical development strategy and any applicable regulatory requirements, advice and / or guidance. This includes defining eligibility criteria, selecting appropriate endpoints, and ensuring assessments are adequate to capture necessary data in support of endpoints.
• Author and/or contribute to clinical documents: Author clinical study protocols, contribute to clinical trial training materials (e.g Site Initiation Visit Slides), development of informed consent form and other patient materials, case report forms (CRFs) design, statistical analysis plans (SAPs) and clinical study reports (CSRs).
• Data Collection and analysis: Collaborate with clinical operations, biostatistics and data management teams to clean and analyze clinical trial data, interpret results, and prepare clinical study reports.
• Regulatory Submissions: Contribute to the preparation of regulatory documents, including Investigational New Drug (IND) applications, Investigator’s Brochures (IBs), and New Drug Applications (NDAs).
• Stakeholder Collaboration: Liaise with internal and external stakeholders, including investigators, key opinion leaders (KOLs), and regulatory authorities.
• Scientific Communication: May present clinical data and development plans to internal teams, external partners, and at scientific conferences.
• Medical Monitoring: May provide support for medical monitoring activities and/or serve as Medical Monitor for assigned trials.