Senior Medical Director, Medical Monitor

• Provide medical oversight of clinical trials to ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements
• Manage all medical aspects of contracted tasks across the pharmaceutical product life cycle
• Ensure tasks delegated to Pharmacovigilance are properly executed
• Adhere to applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies
• Provide medical consultation to team members and answer study-related medical questions
• Provide therapeutic and protocol training on assigned studies
• Assist in writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related documents
• Contribute to departmental process improvement initiatives
• Monitor safety variables, including adverse events, laboratory abnormalities, patient medical status, concomitant medications, and un-blinding requests
• Discuss medical concerns with principal investigators and clients and support clinical decision-making
• Provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events
• Perform contracted data review and validation, including coding listings and/or full safety data
• Manage signal detection activities and generate aggregate reports
• Contribute to label updates, dossier maintenance, and risk management activities
• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, and project team members
• Support business development activities

• MD or equivalent required
• Active medical licensure preferred
• Clinical experience treating patients in hema oncology or a related sub-specialty, 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
• Broad expertise or unique knowledge in the functional area
• Ability to develop solutions to highly complex and unique issues
• Ability to exercise independent judgment in methods, techniques, and evaluation criteria
• Ability to serve as a consultant and spokesperson on highly significant matters
• Ability to create formal networks with key decision makers

• Fully remote work arrangement
• Full-time employment