ProKidney Corp.

Clinical Research

• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous late stage clinical trials.
• Contribute to the development of study protocols, investigator brochures, informed consent forms, and other essential study documents.
• Provide scientific input for trial endpoints, patient populations, and statistical analyses.
• Act as the scientific lead for assigned late stage studies, ensuring adherence to clinical trial protocols and regulatory requirements.
• Provide ongoing scientific and clinical input during trial execution, including participation in investigator meetings, site initiation visits, study monitoring activities, and medical data review.
• Review and interpret clinical trial data, ensuring consistency and alignment with study objectives.
• Address protocol-related questions from investigators and site staff.
• Contribute to the preparation of regulatory submissions, including clinical study reports (CSRs) and documentation for Investigational New Drug (IND) and New Drug Application (NDA) filings.
• Ensure clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory standards.
• Collaborate with the Biostatistics and Data Management teams to review and interpret study data, ensuring accuracy and completeness.
• Participate in the preparation of abstracts, presentations, clinical study reports, and manuscripts for scientific meetings and publications.
• Partner with cross functional team members to develop and execute clinical development strategies.
• Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.

Clinical Scientist