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
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, and project team members
• Support business development activities
• Manage medical aspects of contracted tasks across the pharmaceutical product life cycle
• Ensure tasks delegated to Pharmacovigilance are properly executed
• Follow applicable regulations, ICH guidelines, client SOPs/directives, project WPDs, and corporate policies
• Answer study-related medical questions and maintain clear communication with associates and clients
• Provide therapeutic and protocol training
• Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• 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 apply medical judgment to clinical-study decisions
• Medically review adverse events of special interest, serious adverse events, and clinical outcome events
• Perform contracted data review and validation, including coding listings and full safety data review
• Manage signal detection activities and generate aggregate reports for marketed products
• Contribute to label updates, dossier maintenance, and risk-management activities
• Review adverse-event and serious-adverse-event data from solicited, spontaneous, and literature sources
• Serve as a consultant or spokesperson for the functional area and create formal networks with key decision makers

• MD or equivalent required
• Active medical licensure preferred
• Clinical experience treating patients in hemato-oncology or a related subspecialty, comparable to 2 years
• One of the following: suitable clinical trial experience in a contract research organization, pharmaceutical company, or as a principal investigator, comparable to 1–2 years; or direct safety/Pharmacovigilance experience, comparable to 2 years
• Broad expertise or unique knowledge relevant to company objectives and principles
• Ability to develop solutions to highly complex and unique issues impacting future concepts, products, or technologies

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