Sr. Manager/AD Clinical Research
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About The Position
Our client is currently seeking a Sr. Manager/AD Clinical Research who will play a pivotal role in driving the clinical development strategies for investigational products. This individual will lead protocol design, analyze clinical trial data, and guide study execution. A key aspect of this role involves developing strong relationships with principal investigators (PIs) and key opinion leaders (KOLs), while staying informed on emerging science and regulatory issues that may impact clinical research. The ideal candidate will possess expertise in clinical trials and ensure compliance with Good Clinical Practice (GCP), providing clinical training for stakeholders as necessary. In this position, the Sr. Manager/AD Clinical Research will collaborate across various departments, lead data reviews, and participate in site interactions. A detail-oriented and proactive approach is essential, as well as strong leadership skills to navigate the fast-paced environment of clinical research. The responsibilities include driving clinical development strategies and executing assigned investigational products, developing study protocol synopses, leading benefit/risk analyses for clinical development protocols, and validating final study protocols and amendments. The individual will also support the clinical operations team during feasibility assessments and study execution. Additionally, the role requires identifying and building relationships with PIs and KOLs in drug development, seeking external resources to gain insights into emerging science in drug and biomarker research, and developing a comprehensive understanding of the etiology, natural history, diagnosis, and treatment of relevant disorders. The candidate will hold strong expertise in specific disease areas by attending scientific conferences and continuously reviewing relevant literature. Keeping abreast of development and regulatory issues related to competitive compounds is also crucial, as is leading data reviews of trial data, including eligibility assessments, and ensuring continuous real-time review of aggregated data during clinical trial conduct. The individual will support clinical trials and participate in site interactions and education, covering specific disease areas, drug mechanisms of action, protocol requirements, and safety management guidelines. Furthermore, providing clinical training for internal stakeholders and clinical trial sites will be a significant part of this role.
