Christian Andersen, Phd Email & Phone Number

Currently, I serve as a Senior Scientist II/Toxicologist for Schrodinger Therapeutics Group. Using experience gained as a Study Director, I initiate, design, monitor and analyze nGLP/GLP pre-clinical safety assessment studies at clinical research organizations across the world. Working with internal drug discovery teams, I provide Toxicology Subject Matter Expertise to guide potential new therapeutics through the regulatory landscape from pre-IND to marketing. Using my skills with big data analytics, I am designing new models to analyze the thousands of data points that are generated in a single pre-clinical study, data that will hopefully help reduce the number of animals needed and provide more robust, holistic analysis.

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  Senior Scientist Ii, Toxicology

  Schrödinger

  Feb 2024 - Present - New York City Metropolitan Area

  Serves as toxicology representative to discovery and development teams.Works cross-functionally with research teams to design exploratory and GLP compliant toxicology studies to investigate properties of candidate compounds.Designs and implements regulatory toxicology studies to support development of clinical stage therapeutics.Authors regulatory submissions documents (IB, IND, BLA, Annual Reports) as needed to support development programs.Maintains currency with internal training and global regulatory requirements.Acts as Toxicology study monitor and liaison to external contract research organizations (CROs).Travels to CRO sites during study conduct to ensure regulatory compliance and effective execution of study protocols.Analyze and interpret data, determine next steps, and communicate results to development teams and management.Authors Safety Data Sheets (SDS) for Drug Products.Develop OEBs/OELs for Drug Substances.Development of in-silico techniques to assess off-target receptor binding through the use of Schrodinger platform.Serve as Toxicology representative to cross-functional Quality Assurance working group to implement a Quality Management System.