Senior Medical Director, Medical Monitor

• Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed
• Attends and presents at investigator and sponsor meetings
• Provides medical consultation to clients, investigators, and project team members
• Supports business development activities
• Manages medical aspects of contracted tasks across the pharmaceutical product life-cycle
• Ensures tasks delegated to Pharmacovigilance are properly executed
• Provides medical consultation and answers study-related medical questions
• Provides therapeutic and protocol training on assigned studies
• Writes and/or reviews CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Contributes to departmental process improvement initiatives
• Monitors safety variables including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests
• Discusses medical concerns with principal investigators and clients and applies medical judgment to clinical situations
• Reviews adverse events of special interest, serious adverse events, and clinical outcome events
• Performs data review and validation, including coding listings and/or full safety data, to assess potential safety concerns
• Manages signal detection activities and generates aggregate reports
• Contributes to label updates, dossier maintenance, and risk management activities
• Medically reviews adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources
• Serves as a consultant and spokesperson for the functional area or organization on significant matters
• Creates formal networks with key decision makers

• MD or equivalent required
• Active medical licensure preferred
• Clinical experience treating patients in hematology oncology or a related subspecialty, comparable to 2 years
• Suitable clinical trial experience in a contract research organization, pharmaceutical company, or as a principal investigator, comparable to 1–2 years; or direct experience in safety/Pharmacovigilance, comparable to 2 years
• Knowledge of applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues
• Ability to adhere to client SOPs/directives, project-specific WPDs, and corporate policies and SOPs/WPDs
• Ability to exercise independent judgment in methods, techniques, and evaluation criteria
• Broad expertise or unique knowledge to contribute to company objectives and principles
• Ability to develop solutions to highly complex and unique issues

• Fully remote work arrangement
• Standard Monday–Friday work schedule