About the role

Medical Director overseeing endocrinology clinical trials and drug safety for Thermo Fisher Scientific. Providing medical monitoring, adverse-event review, regulatory support, and investigator consultation.

Responsibilities

Provide medical oversight of clinical trials to ensure SOPs, client directives, good clinical practice, and regulatory requirements are followed
Manage and oversee contracted services
Attend and present at investigator and sponsor meetings
Provide medical consultation to clients, investigators, project teams, and associates
Support business development activities
Provide medical review and analysis of clinical trial serious adverse events
Ensure delegated medical-monitor tasks are properly executed
Provide therapeutic and protocol training
Write and/or review CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
Monitor 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 interpret inclusion/exclusion criteria
Review adverse events of special interest, serious adverse events, and clinical outcome events
Perform data review and validation, including coding listings and full safety data review
Manage signal detection activities and review aggregate reports for marketed products
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
Formal training in Endocrinology Diabetes & Metabolism (residency and/or fellowship)
Patient treatment experience comparable to 2 years
For Senior Medical Director: 1–2 years of suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator, or 2 years of direct safety/Pharmacovigilance experience
Active medical licensure preferred but not required
Therapeutic expertise in Neurology
Strong decision-making, problem-solving, organizational, and analytical skills
Excellent oral and written communication skills
Working knowledge of relevant safety databases, e.g. MedDRA
Flexibility to travel domestically and internationally
Ability to work independently and prioritize sensitive, complex information
Proficiency in basic computer applications
Fluent in spoken and written English
Understanding of FDA, ICH, EMA, and GCP guidelines
Working knowledge of biostatistics, data management, and clinical operations procedures
Ability to mentor/train other staff
Must be legally authorized to work in the United States or Canada without sponsorship
Must be able to pass a comprehensive background check, including drug screening where applicable
Regular and consistent attendance
Ability to perform office-based physical and computer-related duties, including occasional lifting of 15–20 lbs