Medical Director

• Work with business development and internal stakeholders to critically appraise protocols, propose study designs, and develop endpoints
• Serve as primary medical monitor and first point of contact for clinical trial sites
• Answer site questions about eligibility and enrollment; perform safety and patient management
• Advise on medical questions and issues arising during clinical trials
• Define, plan, and provide medical monitoring for assigned trials with cross-functional teams and sponsors
• Develop and provide medical input to Medical Monitoring Plans and Safety Management Plans
• Review protocols and protocol training materials
• Train project teams on disease or therapeutic area, study design, and procedures
• Attend and participate in Investigator Meetings when applicable
• Support decisions concerning inclusion/exclusion deviations and protocol-related questions
• Respond to medical queries from Investigators, Ethics Committees, and Data Monitoring Committees
• Provide emergency medical guidance outside normal business hours by telephone and email
• Document protocol inquiries and answers in the centralized tracker/CTMS
• Review listings, laboratory reports, subject profiles, safety data, medical histories, concomitant medications, and patient-risk trends
• Provide medical oversight to identify safety concerns and adverse events and develop appropriate responses
• Consult on out-of-range laboratory values for clinical and protocol significance
• Advise Pharmacovigilance/Drug Safety on SAE case assessment and reporting
• Review subject narratives, periodic and interim safety reports, and study documentation
• Assist with medical review of MedDRA-coded adverse-event and medical-history terms and WHODrug-coded concomitant medications/therapies
• Review Statistical Analysis Plans, tables, figures, listings, and Clinical Study Reports as needed
• Ensure compliance with company Standard Operating Procedures and clinical-trial safety medical-monitoring practices

Explore Medical Director – Oncology at Everest Clinical Research. Review requirements and application details.