Location: Austin, Texas
My client is a top ranked global Clinical Research Organization (CRO) who prioritize collaboration and development as they strive to deliver life-saving therapies to patients more efficiently. They are seeking Physicians who are able to provide their medical expertise to support clinical development needs. As an Associate Medical Director, you will provide medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
This is an opportunity with a notorious company who strongly value work/life balance, offering continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of their employees.
Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
Attend and present at investigator and sponsor meetings
Provide medical consultation to clients, investigators and project team members and support business development activities.
Provide medical review and analysis for clinical trial serious adverse events, marketed products ICSR and periodic safety reports (e.g., PBRER, PSUR, DSUR) as well as other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP and CSR).
Oversee PVG to ensure tasks are properly executed.
Adhere to client SOPs/directives and project specific WPDs for assigned projects.
Provide medical consultation to team members and answer all study related medical questions.
Provide therapeutic training and protocol training on assigned studies.
Assist in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete.
Clinical Trial Support:
Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies.
Discuss all medical concerns with principal investigators and clients (e.g., discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
Provide medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
Perform data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.
Marketed Products Support:
Manage signal detection activities, scientifically reviews aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.
MD or equivalent required. Active medical licensure or ability to obtain.
Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years); Or
Suitable clinical trial experience in a CRO, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry; Or
Direct experience in safety/Pharmacovigilance (comparable to 2 years).
Therapeutic expertise across one or more medical specialty or sub-specialties
Working knowledge of relevant safety databases (e.g., Medra)
Flexibility to travel domestically and internationally
Ability to work independently, analyze work with attention to detail, process and prioritize sensitive complex information
Understanding guidelines (FDA, ICH, EMA and GCP)
Working knowledge of biostatistics, data management, and clinical operations procedures
Salary: On application
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