Work closely with CROs to enable all aspects of the discovery process, including, protein expression and purification, assay development, high-throughput screening, mechanistic studies, and structural biology.
This position will primarily be responsible for leading CMC regulatory strategy development/execution and regulatory submission management for early development through late-stage (phase 3, registration, post-approval) programs and based on U.S. and International requirements as defined in FDA, EMA, and other HA.
The Clinical SAS programmer, Senior Manager, is responsible for designing, developing, validating and maintaining datasets and tables, listings and figures (TFLs) for ad hoc requests or regulatory submissions in compliance with CDISC, SDTM/ADaM standards as well as regulatory business rules.
This position will be responsible for leading the development and implementation of a consolidated (global) regulatory strategy to secure and maintain market access for the assigned product through all development phases and through post-approval life-cycle management.
The Sr. Clinical Trial Manager is responsible for planning, implementing and managing a small number of studies of basic to moderate complexity or supporting more complex, multicenter studies, overseeing specific study activities and/or vendors.
Oversee the development of medium-to-high throughput plate-based biochemical assays, including direct binding, fluorescence based, and enzymatic assays, to facilitate compound screening and support medicinal chemistry efforts.