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Performing hands-on PBPK, QSP, and clinical trial simulations on an assigned project. Supporting the development of a team from both a technical and scientific perspective to ensure state-of-the-art mechanistic approaches are applied to optimize drug
Provide appropriate clinical scientific input & support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized
Accountable for the strategic leadership and operational excellence of global clinical trials, driving delivery across all phases and therapeutic areas. This role sets the vision for successful trial execution, influences organizational strategy, and
Evaluating the required regulatory activities and preparing the respective documentation as well as submission schedules under consideration of local provisions and laws of the various countries. Clarifying the necessary steps for acquiring and
The role is accountable for proactive safety surveillance, signal management, benefit–risk evaluation, and risk mitigation activities, in close partnership with Drug Safety & Pharmacovigilance internal team and cross-functional stakeholders