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Associate Director, Investigator Initiated Trials

BeiGene · US

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for s...

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Responsible for the effective management of all aspects of Investigator-initiated Trials (IITs) including implementation in multi-institutions and research settings in accordance with FDA regulations and Good Clinical Practice guidelines. This role will also assist with program management, including use of the BeOne contract system for creating and tracking contracts and report creation through the IIT portal. Support the review process for medical affair studies. Essential Functions of the Job: - Support IIT operations and project management, cross-functional collaborations, process improvement, and vendor management. This includes tracking and measurement of IIT KPIs. - Act as the Medical Internal Review Committee (MIRC) lead. Review submitted proposals and protocols, adjudicate revised proposals and protocols based on MIRC comments, set the MIRC agenda, dev...