Director, Medical Monitor, Nephrology (MD Required)

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.

The Medical Monitor serves as the medical expert for assigned clinical trials ensuring the safety of the participants and integrity of the data collected. S/he is responsible to review and/or generate key study documents (such as medical monitoring and safety management plans, treatment manuals, etc.), assess and interpret safety data, and contribute to investigator, other site staff and clinical study team training. The Medical Monitor is the main point of contact for Investigators for medical questions and oversees the medical monitoring teams at the clinical research organizations (CROs). S/he will provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the internal study team.

The Medical Monitor will also assist the department head in the development and execution of patient safety and pharmacovigilance activities by providing oversight of study patients’ safety matters. S/he works closely with other departments, regulatory bodies, and investigator sites to ensure that proper plans are in place to ensure proper medical oversight, manage adverse events and ensure compliance with regulatory requirements

Safety Monitoring:

• Review and assess adverse events, serious adverse events and potential SUSARs reported during the trial.
• Ensure timely and appropriate medical management of adverse events.
• Conduct safety assessments and risk analyses.

Protocol Oversight:

• Review and ensure adherence to the study protocol and regulatory requirements.
• Provide medical input and support in the development and revision of study protocols.

Data Review:

• Oversee the quality and integrity of medical data collected during the study.
• Review and analyze clinical trial data to identify trends or issues related to patient safety.
• Medical coding review

Regulatory Compliance:

• Ensure that the study complies with all regulatory requirements, including FDA, EMA, and other relevant bodies.
• Prepare and review regulatory submissions and reports.

Medical Consultation:

• Provide medical expertise and consultation to clinical trial teams and investigators.
• Assist in the interpretation of clinical data and provide guidance on medical and scientific issues.
• Patient eligibility review
• Answer medical questions from site or project team

Training and Support:

• Provide training and support to clinical staff and investigators on medical aspects of the trial.
• Participate in site visits and monitor the conduct of the trial at clinical sites.

Communication:

• Act as a liaison between the study sponsor, regulatory authorities, and clinical sites.
• Prepare and present reports and updates on the medical aspects of the trial.

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.