Medical Director – Dermatology

• 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, and project team members
• 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 and comply with regulations, ICH guidelines, client directives, and company SOPs/WPDs
• Answer study-related medical questions and maintain communication with associates and clients
• Provide therapeutic and protocol training on assigned studies
• Assist with writing and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Monitor clinical-trial 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 make clinical judgments regarding investigational studies
• Review adverse events of special interest, serious adverse events, and clinical outcome events
• Perform contracted data review and validate safety data, coding listings, and potential safety concerns
• Manage signal-detection activities and 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
• At least one of: clinical experience treating patients in the relevant specialty/sub-specialty comparable to 2 years; suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator comparable to 1–2 years; 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
• 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
• Ability to travel domestically and internationally
• Ability to work independently, analyze work with attention to detail, and process 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/train other staff within Pharmacovigilance
• In some cases, an equivalency combining appropriate education, training, and/or directly related experience may be considered

• Fully remote work mode
• Standard Monday–Friday work schedule
• Career goals and professional development resources
• Mentoring/training opportunities
• Global and international work exposure
• Occasional domestic and international travel