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Medical/Senior Medical Director
3 months ago
Medical/Senior Medical Director - Nephrology
Wilmington ,
North Carolina
Apply Now
Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed.
Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team members and supports business development activities.
Provides 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)Essential Functions:
Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
General Support:
Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD's corporate policies and SOPs/WPDs.
Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
Provides therapeutic training and protocol training on assigned studies, as requested.
Assists 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.Contributes to departmental process improvement initiatives.
Clinical Trial Support:
Monitors 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.
Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported by study sites.
Performs 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:
Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.
Qualifications:
Education and Experience:
MD or equivalent required. Active medical licensure preferred.
Candidates should have a combination of clinical experience and industry experience as follows:
Clinical experience in treating patients in the speciality or sub-speciality associated with the applicants training(comparable to 2 years) and one of the following:
Suitable clinical trial experience in a Contract Research Organization, 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).
Additional experience required for Sr Med Director level. Experience should be industry specific(CRO/Pharma). Management/Leadership experience additionally required.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
Therapeutic expertise across one or more medical specialty or sub-specialties
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
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
Proficiency in basic computer applications
Fluent in spoken and written English Excellent interpersonal, influencing and team building skills
Understanding guidelines (FDA, ICH, EMA and GCP)
Working knowledge of biostatistics, data management, and clinical operations procedures
Ability to act as a mentor/trainer to other staff within PVG
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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