Nonclinical Studies Manager - (Buffalo, NY)

As a Nonclinical Studies Manager in Preclinical Sciences you will collaborate closely with internal Preclinical, Toxicology, Regulatory, and Clinical staff as a subject matter expert in nonclinical study design, and you will with work with external CROs to provide oversight in the review and/or QC of study proposals, protocols, data, and reports, in support of Athenex development programs. You will participate in project team meetings and help to manage and drive nonclinical timelines for regulatory submissions. You will serve a technical writing role, composing nonclinical summaries and/or reports for pharmacology, pharmacokinetic pharmacology studies conducted by or on behalf of Athenex, and be an expert user of the nonclinical document templates that are consistent with FDA and ICH guidelines and with electronic submissions guidelines. Key assignments include the following: