Medical Director – Senior Medical Director, Psychiatry

• Provide medical oversight of psychiatric clinical trials
• Ensure company SOPs, client directives, good clinical practice and regulatory requirements are followed
• Manage and oversee contracted services throughout clinical trial development
• 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
• Ensure tasks delegated to medical monitors are properly executed
• Provide medical, therapeutic and protocol training
• 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 situations
• Review adverse events of special interest, serious adverse events and clinical outcomes events
• Review coding listings and/or full safety data to assess potential safety concerns
• Mentor and train other staff

• MD or equivalent required
• Clinical experience in Psychiatry and formal training in Psychiatry (residency and/or fellowship)
• Patient treatment experience comparable to 2 years
• For Senior Medical Director: suitable clinical trial experience in a Contract Research Organization or pharmaceutical company comparable to 1–2 years
• Preference toward clinical development/medical monitoring experience
• Must be legally authorized to work in the hiring country without sponsorship
• Must be able to pass a comprehensive background check, including drug screening where applicable
• Therapeutic expertise in Psychiatry
• Working knowledge of relevant safety databases, such as MedDRA
• Fluent in spoken and written English
• Understanding of FDA, ICH, EMA and GCP guidelines
• Working knowledge of biostatistics, data management and clinical operations procedures
• Proficiency in basic computer applications
• Ability to travel domestically and internationally
• Active medical licensure preferred but not required

• Annual incentive plan bonus
• Healthcare
• Employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Collaboration and development opportunities