What are the responsibilities and job description for the Nephrology Medical Director position at Infotree Global Solutions?
Job Summary
This role leads medical aspects of clinical development and drug development projects focused on nephrology. The ideal candidate will have expertise in nephrology therapeutic areas and clinical drug development, with a strong understanding of regulations, ICH guidelines, and client-specific directives.
Main Responsibilities:
- Ensure compliance with regulatory requirements and ICH guidelines for nephrology-focused clinical trials.
- Provide expert medical consultation on nephrology to project teams, clients, and investigators.
- Conduct therapeutic and protocol training on nephrology-related studies.
- Assist in the review and interpretation of safety and efficacy data for nephrology-focused clinical trials.
- Monitor safety variables, including adverse events, lab results, and protocol adherence in nephrology trials.
- Support marketed nephrology products by overseeing signal detection and contributing to labeling updates.
Qualifications:
- MD with specialization in Nephrology; active medical licensure preferred.
- Minimum of 3-5 years of clinical experience in nephrology or related fields.
- Expertise in nephrology therapeutic areas and clinical drug development.
- Familiarity with FDA, ICH, EMA, and GCP guidelines as they relate to nephrology.
Requirements:
- In-depth knowledge of nephrology, clinical development, and drug development processes.
- Ability to work independently, handle sensitive nephrology-related data, and manage complex information.
- Fluent in English, with a strong ability to communicate nephrology-specific concepts.
Additional Information:
The selected candidate will be required to travel domestically and internationally for nephrology clinical projects.
