Medical Director – Rheumatology

• Provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed
• Attend and present at investigator and sponsor meetings
• Provide medical consultation to clients, investigators, project team members, and associates
• Support business development activities
• Provide medical review and analysis for clinical trial serious adverse events, marketed-product ICSRs, periodic safety reports, and other client deliverables
• Ensure Pharmacovigilance-delegated tasks are properly executed
• Follow applicable regulations, ICH guidelines, client SOPs/directives, project-specific WPDs, and corporate policies
• Provide medical consultation 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, and CTD modules
• Monitor safety variables including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and unblinding requests
• Discuss medical concerns with principal investigators and clients and interpret clinical situations related to investigational studies
• Review adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites
• Perform data review, including coding-listing and full-safety-data review, to assess potential safety concerns
• 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

• MD or equivalent required
• Active medical licensure preferred
• Clinical experience in rheumatology or an associated specialty/sub-specialty, comparable to 2 years
• Or 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
• For Senior Medical Director: clinical experience comparable to 2 years plus suitable clinical trial experience comparable to 1–2 years or direct safety/Pharmacovigilance experience comparable to 2 years
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Therapeutic expertise across one or more medical specialties or sub-specialties
• Strong decision-making, problem-solving, organizational, and analytical skills
• Excellent oral and written communication skills
• Working knowledge of relevant safety databases, such as MedDRA
• Flexibility to travel domestically and internationally
• Ability to work independently and analyze and prioritize sensitive, complex information
• Proficiency in basic computer applications
• Fluent spoken and written English
• Excellent interpersonal, influencing, and team-building skills
• Understanding of FDA, ICH, EMA, and GCP guidelines
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Ability to mentor and train other Pharmacovigilance staff

• Fully remote work mode
• Standard Monday–Friday work schedule
• Opportunities to support meaningful work improving health outcomes
• Occasional domestic and international travel
• Healthy and balanced work environment support
• Mentoring and training opportunities