What are the responsibilities and job description for the Nephrology Medical Director Expert position at Infotree Global Solutions?
Job Overview:
We are seeking a highly skilled Nephrology Medical Director to lead our clinical development and drug development projects focused on nephrology.
- As a key member of our team, you will ensure compliance with regulations, ICH guidelines, client-specific directives, and nephrology-focused clinical protocols.
- You will provide expert medical consultation on nephrology to project teams, clients, and investigators.
- The ideal candidate will conduct therapeutic and protocol training on nephrology-related studies.
- You will also assist in the review and interpretation of safety and efficacy data for nephrology-focused clinical trials, including ICSRs, signal detection, periodic reports, and labeling documentation.
- Monitoring safety variables, including adverse events, lab results, and protocol adherence in nephrology trials is another critical aspect of this role.
- You will provide medical review of nephrology-specific serious adverse events and clinical outcomes, ensuring patient safety and accurate data analysis.
- This position requires strong decision-making, problem-solving, and organizational skills, with a focus on nephrology.
Requirements:
- A MD with specialization in Nephrology; active medical licensure preferred.
- Minimum of 3-5 years of clinical experience in nephrology, clinical trial experience in nephrology drug development, or pharmacovigilance experience within nephrology.
- Expertise in nephrology therapeutic areas and clinical drug development.
- Familiarity with FDA, ICH, EMA, and GCP guidelines as they relate to nephrology.
- Ability to work independently, handle sensitive nephrology-related data, and manage complex information.
