Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.
We are seeking a highly motivated and experienced Clinical Scientist to join our clinical development team, focusing on the design, execution, and oversight of Phase 3 clinical trials. The Clinical Scientist will play a critical role in advancing our clinical programs, ensuring the generation of high-quality data, and contributing to the successful submission of regulatory dossiers.
Key Responsibilities:
Clinical Trial Design and Planning:
- Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Biostatistics, and Regulatory Affairs, to design scientifically rigorous Phase 3 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.
- Study Execution and Oversight:
- Act as the scientific lead for assigned Phase 3 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, and study monitoring activities.
- Review and interpret clinical trial data, ensuring consistency and alignment with study objectives.
- Address protocol-related questions from investigators and site staff.
Regulatory and Compliance:
- 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.
Data Analysis and Reporting:
- 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, and manuscripts for scientific meetings and publications.
Cross-Functional Collaboration:
- Partner with Medical Directors to develop and execute clinical development strategies.
- Serve as a subject matter expert within the clinical team, providing scientific insights to support decision-making.
Essential Duties & Responsibilities:
Minimum Qualifications:
- Advanced degree in a scientific discipline (PhD, PharmD, MD, or equivalent) required.
- Minimum of 3+ years of experience in clinical research, with a focus on Phase 3 trials preferred.
- 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.
Preferred Qualifications:
- Experience in a specific therapeutic area (e.g., oncology, cardiology, or rare diseases) relevant to the company's pipeline.
- Familiarity with regulatory requirements for global clinical trials, including FDA and EMA guidelines.
- Proficiency in using clinical trial management systems and other relevant software.
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
