Thorough Senior Analyst with over a 10-year background in the Pharmaceutical industry across different functions including R&D Finance, R&D Clinical Pharmacology, and Clinical Operations . Excellent planning, organizational and communication skills. Self-reliant to perform analysis and make data driven recommendations. Talented in financial forecasting and data analysis.
-Conduct financial analyses to forecast financial Last Best Estimates (LBE) on clinical studies across the oncology platform.
-Forecast cost to conduct clinical studies based on gathered historical data to assist in portfolio planning.
-Gathers data from a variety of sources and provides quality clinical study budget information and metrics to Clinical and Finance Leadership to aid in planning decisions.
-Supports business operations in assessing and investigating actual study spend via SAP data vs. forecasted cost.
-Oversee clinical operations for a global oncology clinical study.
-Management of clinical study related activities including study start up activities.
-Management of vendors contributing critical aspects of clinical studies including central labs and central imaging vendors.
-Identify and resolve study related issues and inefficiencies.
-Facilitate study wide communications to internal cross functional teams and external stakeholders.
-Analyze Phase I/II/III oncology data for large and small molecule therapeutics and generate figures, tables, and data visualization for presentation to senior scientific leadership.
-Analysis of study safety data and protocol deviations for disclosure in FDA required clinical study reports.
-Author phase I clinical study reports, population pharmacokinetic reports, exposure-response, exposure-safety and pharmacogenomic reports for FDA and global regulatory submissions.
-Prepare scientific posters for various conferences and presentations.
-Contribute in production of scientific manuscripts for journal submission.
-Experience with therapeutics for both solid and hematological cancers.
-Management of 175 global study sites and associated staff.
-Responsible for phase I- IV clinical studies.
-Management of trial master file (Veeva eTMF) in preparation of FDA audits.
-Ensuring compliance of clinical studies.
-Liason between the clinical central laboratory, project management, and clients.
-Expedite patient data availability to clients for urgent clinical studies.
-Oversee input and accuracy of clinical data for clients.
-Tumor Immunology research assessing the use of tumor reactive T Cell Receptors in adoptive gene therapy using immunological and molecular biology based assays.
-Development of immunotherapies for use in the clinic for a variety of cancers and other pathologies.
-Generation of data from individually conducted research.
-Presentation of data to professionals within cancer research field, but also other outside of the field.
-Preparation of Serious Adverse Events reports for IRB and FDA submission.
-Collaboration with principal investigators at Loyola for initiation of phase I oncology trials.
-Entry of clinical trial data for oncology studies.
-Clinical Study Financial Forecasting
-Data Analytics
-Quantitative Analysis
-Advanced Mathematics
-Microsoft Excel
-Microsoft PowerPoint
-Data Visualization and Presentation
-Tableau
-R
-SAP
-Clinical Study Operations
-Vendor Management
-Cross Functional Team Work
-Molecular Oncology
-Cancer Biology
-Immunology
-Molecular biology
-Biochemistry
-Tumor immunology
-Immunotherapy