Role Overview

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.

Requirements

BA/BS required with 10+ years of relevant experience
Advanced degree in a scientific discipline (PhD, PharmD, MD, or equivalent) preferred.
Late-stage development/registrational study experience, and specifically filing experience i.e. BLA or NDA
Comprehensive understanding of drug development processes and GCP guidelines.
Proven ability to interpret and synthesize clinical and scientific data.
Strong written and verbal communication skills, with experience preparing regulatory documents and scientific publications.
Ability to work collaboratively in a fast-paced, team-oriented environment.
Detail-oriented with strong organizational and project management skills.

Tech Stack

Google Cloud Platform

Benefits

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

ProKidney Corp.

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Healthcare

Clinical Scientist