Associate Medical / Medical Director - Nephrology, EMEAJoin Thermo Fisher Scientific as an Associate Medical / Medical Director - Nephrology, EMEA .Work Schedule :
Standard (Mon-Fri)Environmental Conditions :
OfficeAt Thermo Fisher Scientific, we make a positive impact on a global scale by enabling our customers to make the world healthier, cleaner, and safer. We support our teams with resources to achieve career goals and advance science through research, development, and delivery of therapies. Our work includes clinical trials in over 100 countries and innovative frameworks for clinical research within our PPD portfolio, spanning laboratory, digital, and decentralized services.Role Overview :
The Medical Director provides medical support and advice for clinical trials and safety evaluations within the PPD Pharmacovigilance department.Key Responsibilities :
Provide medical leadership to study teams, including developing clinical trial protocols based on the latest scientific information, contributing to site selection, and reviewing / approving study documents such as protocols, amendments, CSRs, ICFs, and CRFs.Monitor clinical studies in real-time to ensure medical validity and subject safety, identifying issues early and consulting with the Global Medical Indication Lead as needed.Review protocols, support procedural and budgetary considerations, and serve as the liaison between sponsors and internal departments throughout study phases. Educate investigator sites and handle daily trial activities.Act as the medical point of contact for stakeholders, interacting with investigators, responding to IRBs and Health Authorities, and providing medical training at investigator meetings and for CRAs.Ensure compliance with SOPs and GCP for all medical aspects of the study.Collaborate with cross-functional team members to clarify medical risks, issues, and results.Qualifications :
MD, MB / BS, or equivalent degree with strong medical knowledge and clinical experience in Nephrology.Skills and Experience :
Extensive experience in the pharmaceutical industry, clinical trials, and pharmaceutical medicine.Fluent in spoken and written English.Understanding of NDA submission processes and regulatory guidelines for adverse event reporting.Excellent communication, presentation, and teamwork skills.Join us in our mission to make the world healthier, cleaner, and safer. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse backgrounds are valued.Apply today!Thermo Fisher Scientific is an Equal Opportunity Employer, committed to diversity and inclusion.Seniority level :
Not ApplicableEmployment type :
Full-timeJob function :
Research and ScienceIndustries :
Pharmaceutical Manufacturing and Biotechnology ResearchJ-18808-Ljbffr
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