Description
This position is focused on translational medicine and safety risk management in early drug development. It is a strategic role focused on characterizing the safety profile of molecules prior to entry into human and into early clinical development. Key responsibilities include ongoing risk assessment and evaluation of clinical trial data; creating appropriate risk communication documents and reference safety information; and designing and implementing risk mitigation measures in the clinical trial setting.Additional activities include signal detection and evaluation, including the analysis, reporting, and communicating of results; contributing to and/or participating in health authority interactions, data safety monitoring boards or independent review committees; and otherwise representing the safety risk management function on cross-functional teams within the development organization.
The position requires significant medical expertise and industry experience in drug safety and/or clinical development, ideally in the translational setting. The successful candidate will have a medical degree with clinical practice experience that serves as the foundation for sound medical evaluation and medical decision-making; significant experience in the biopharmaceutical industry in drug safety and/or clinical development with expert knowledge of international pharmacovigilance regulations and requirements, good clinical practice, and clinical trial design and evaluation.
Education - Physician required (M.D. or international equivalent)
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