Medical Director

• Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
• Manage and oversee contracted services
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, project team members, and internal team members
• Support business development activities
• Provide medical review and analysis of clinical trial serious adverse events
• Ensure tasks delegated to medical monitors are properly executed
• Monitor adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests
• Discuss medical concerns with principal investigators and clients and apply medical judgment to clinical situations
• Medically review adverse events of special interest, serious adverse events, and clinical outcome events
• Perform data review and validation, including coding listings and safety data, to identify potential safety concerns
• Provide therapeutic and protocol training
• Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Manage signal detection activities and scientifically review aggregate reports
• Contribute to label updates, dossier maintenance, and risk management activities
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources

Medical Director/Senior Medical Director – Endocrinology

• Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
• Manage and oversee contracted services
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, project teams, and associates
• Support business development activities
• Provide medical review and analysis of clinical trial serious adverse events
• Ensure delegated medical-monitor tasks are properly executed
• Provide therapeutic and protocol training
• Write and/or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Monitor safety variables including adverse events, laboratory abnormalities, patient medical-status changes, concomitant medications, and unblinding requests
• Discuss medical concerns with principal investigators and clients and interpret inclusion/exclusion criteria
• Review adverse events of special interest, serious adverse events, and clinical outcome events
• Perform data review and validation, including coding listings and full safety data review
• Manage signal detection activities and review aggregate reports for marketed products
• Contribute to label updates, dossier maintenance, and risk-management activities
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources

• Manage scientific knowledge and provide strategic, medical, and scientific guidance for upcoming oncology indications, including solid and hematologic malignancies
• Develop, prioritize, and execute strategic and tactical Oncology Medical Affairs plans
• Identify medical and scientific gaps and prioritize tactics to address the needs of clinical scientific leaders
• Serve as the national point of contact for the regional Medical Affairs team
• Collaborate with global and regional teams to secure support for Canadian projects
• Support Phase II and III studies, local clinical evaluations, and investigator-initiated studies
• Encourage the conduct of clinical development studies in Canada
• Act as the medical point of contact for Market Access, Health Economics and Outcomes Research, Clinical Research, Marketing, and Regulatory Affairs
• Support the management of existing products and the launch of new products
• Participate in cross-functional brand teams and provide scientific expertise
• Support product approval submissions and the preparation of regulatory reports
• Establish professional relationships with key scientific leaders in Canada, regulatory agencies, payer groups, and patient advocacy organizations
• Share medical and scientific expertise with Regulatory Affairs, R&D, Quality Assurance, Legal, and Marketing teams

Medical Director jobs in Canada

Medical Director/Senior Medical Director – Endocrinology

Medical Director/Senior Medical Director – Endocrinology

Associate Director (Medical Advisor), Oncology – Pipeline & Hematology