Senior Medical Director - Nephrology

We are excited to announce a prestigious opening for a Senior Medical Director specializing in Nephrology. This contract position is designed for a highly skilled professional ready to manage clinical trials from a remote setting, with occasional travel to various clinical research sites. This contract role is pivotal in ensuring medical oversight and adherence to the strictest compliance standards including company SOP's, client directives, good clinical practice, and regulatory requirements. Responsibilities will also include presenting at key investigator and sponsor meetings, offering expert medical consultations, and contributing to business development efforts.

• Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
• Ensures proper execution of PVG tasks and adherence to regulations, guidelines, and SOP's.
• Provides medical consultation, answers study-related questions, and maintains clear communication.
• Delivers therapeutic and protocol training as needed.
• Assists in writing/reviewing medical content for various reports to ensure accuracy.
• Monitors safety variables in clinical studies.
• Discusses medical concerns with investigators and clients, ensuring proper judgement.
• Reviews adverse events and clinical outcomes reported by study sites.
• Conducts data review per client contract to identify safety concerns.
• Marketed Products Support:
• Manages signal detection and risk activities, reviews aggregate reports, and updates labels.
  
  

• MD or equivalent medical qualification is required. Active medical license is highly preferred
• Nephrology board certification or fellowship
• At least one of the following:
  • Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 3 years)
  • Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 3-5 years) in the industry
  • Direct experience in Safety/Pharmacovigilance (comparable to 3 years).
• Demonstrated therapeutic expertise in Nephrology or related medical specialties/sub-specialties.
• Clinical development experience
• Located on the East Coast / can work East Coast hours
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases (e.g. Medra)
• Flexibility to travel domestically and international
• Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
• Proficiency in basic computer applications
• Fluent in spoken and written English
• Excellent interpersonal, influencing and team building skills
• Understanding guidelines (FDA, ICH, EMA and GCP)
• Working knowledge of bio-statistics, data management, and clinical operations procedures
• Ability to act as a mentor/trainer to other staff
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real, please visit www.realstaffing.com