Senior Medical Director – Endocrinology

• Provide medical oversight of clinical trials to ensure 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
• Manage medical aspects of contracted tasks across the pharmaceutical product life cycle
• Ensure PV-delegated tasks are properly executed and comply with regulations, ICH guidelines, client directives and SOPs
• Provide therapeutic and protocol training
• Write or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules and related deliverables
• Monitor safety variables in clinical studies, including adverse events, laboratory abnormalities, patient medical status, concomitant medications and unblinding requests
• Discuss medical concerns with principal investigators and clients and make study-related medical decisions
• Review adverse events of special interest, serious adverse events and clinical outcomes events
• Perform contracted data review and validate coding listings and safety data
• Manage signal detection activities and review aggregate reports
• Contribute to label updates, dossier maintenance and risk management activities
• Medically review adverse-event data from solicited, spontaneous and literature sources

• MD or equivalent required
• Active medical licensure preferred
• Medical Director candidates: clinical experience in the relevant specialty/sub-specialty comparable to 2 years, or suitable clinical trial experience comparable to 1–2 years, or direct safety/Pharmacovigilance experience comparable to 2 years
• Senior Medical Director candidates: clinical experience in the relevant specialty/sub-specialty comparable to 5 years plus suitable clinical trial experience comparable to 4–5 years or direct safety/Pharmacovigilance experience comparable to 5 years
• Equivalency through appropriate education, training and/or directly related experience may be considered
• Therapeutic expertise in one or more medical specialties or sub-specialties
• Working knowledge of relevant safety databases, such as MedDRA
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Understanding of FDA, ICH, EMA and GCP guidelines
• Proficiency in basic computer applications
• Fluent spoken and written English
• Ability to travel domestically and internationally
• Ability to work independently and analyze and prioritize sensitive, complex information
• Strong decision-making, problem-solving, organizational, analytical, communication, interpersonal, influencing and team-building skills
• Ability to mentor/train other staff within PV

• Global team environment
• Resources to achieve individual career goals
• Collaboration and professional development opportunities
• Occasional domestic and international travel
• Healthy and balanced work environment