Julie Shields Email & Phone Number

Boston, Ma, Us

Boston, Massachusetts, Us

- Supported Phase I/II trial conduct for precision oncology therapeutics – including study start-up, conduct, and closeout- Contributed to the development of key study documents including protocol, operational plans, pharmacy manual, patient medication diaries, and CSR- Managed the ICF process including development of the study master ICFs and the review of country- and site-specific ICFs- Managed site feasibility process by contributing to feasibility survey build, tracking site survey responses, and facilitating site selection- Contributed to study systems setup including EDC and IRT (specifications, UAT, CCGs)- Conducted ongoing review and tracking of monitoring visit reports to identify issues with the CRA's report and/or issues at the clinical site- Contributed to ongoing review of study deviations- Oversaw all aspects of sample management including development of lab specifications, lab manuals, kit development, and sample tracking; Ran a weekly Sample Management Meeting to review patient visits, sample collections, queries, upcoming shipments, and scheduled analyses- Participated in ongoing data review to ensure data accuracy, completeness, and compliance with the study protocol; flagged items for querying when required- Created and managed relevant study specific trackers and timelines (enrollment trackers, inspection readiness tracker, issues/FAQ log, etc.) and study tools (sample collection guides, protocol flipbooks for site staff, etc.)- Collected and reviewed site regulatory documents (1572, FDFs, CLIAs, etc.)- Performed TMF QC reviews across the portfolio to ensure documentation completeness, accuracy, and compliance with regulatory standards- Participated in review of study protocols and protocol amendments- Created slide decks for biweekly clinical study team meetings, solicited updates each functional group, and maintained detailed meeting minutes to facilitate discussions and decision making

Boston, Massachusetts, Us

Boston, Massachusetts, Us

- Designed and executed mechanism-of-action studies, including analysis of gene expression, pathway expression, protein levels, and target activity levels, to validate and advance drug discovery programs- Conducted mammalian cell culture-mediated genetic perturbation studies using RNAi and/or CRISPR, as well as pharmacological perturbation studies to validate targets, and understand drug mechanisms of action and resistance- Developed and ran cellular assays (cell viability, target engagement, PD assays) to support target validation and drug discovery SAR efforts- Managed routine assays and mechanistic studies outsourced to CROs- Thoroughly documented experimental materials, methods, and data in electronic laboratory notebook- Independently summarized, analyzed, and presented data during project team meetings; presented troubleshooting and learnings from projects at group biology team meetings- First author on manuscript "VRK1 Is a Synthetic–Lethal Target in VRK2-Deficient Glioblastoma" (Cancer Research, November 2022)

New York, New York, Us

- Performed assay development, assay validation, and sample analysis for nonclinical and clinical ligand binding assays (PK and ADA) to support the large molecule biotherapeutic portfolio; ligand binding assays (LBAs) on MSD and Gyrolab- Functioned as a key member of the Core Automation Team; utilized automation (automated liquid handlers - Hamilton Microlab STAR) to execute design of experiments (DOE) to facilitate assay development/optimization- Analyzed data using various software (Watson LIMS, SoftMax Pro, GraphPad Prism, TIBCO Spotfire, Excel)- Maintained compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Standard Operating Procedures (SOPs)- Authored bioanalytical procedures, validation plans, validation reports, long-term stability reports, deviation memos, job aids, and SOPs- Maintained thorough documentation of experiments in electronic lab notebook- Collaborated with the bioinformatics group to create an automated pipeline for extracting data from Watson LIMS and generating report-ready validation data tables; served as the Subject Matter Expert (SME) for the pipeline- Presented troubleshooting and learnings from projects at group staff meetings (~30 people)- Completed routine maintenance on lab instrumentation and conducted lab safety audits

Ithaca, Ny, Us

- Developed and ran assays for the interrogation of cell-free DNA (cfDNA) to examine DNA methylation and hydroxymethylation as diagnostic biomarkers for organ transplant patients- Extracted cfDNA from urine and plasma samples and performed PCR and qPCR- Utilized immunocapture, on-bead PCR, and chemical labeling techniques- Performed literature searches on the research topic- Participated in monthly journal club (read a research paper and present the key methods and findings to the lab group)

Tokyo, Jp

- Used various molecular biology techniques to isolate subcellular compartments from HEK293 cell line in order to investigate the biodistribution and biotransformation of an antibody-drug conjugate- Optimized an electrochemiluminescence (ECL) assay to quantify antibody-drug conjugate (ADC) isolated from the subcellular compartments- Optimized immunocapture experiments- Performed protein analysis using western blot- Prepared samples for, and reviewed data from fluorescence-activated cell sorting (FACS)- Completed training for the automated assay platform Simoa (Quanterix)

Lawrence Township, Nj, Us

- Performed method development using novel, proprietary reagents and automation to improve drug tolerance in immunogenicity assays- Evaluated methods for drug tolerance, robustness, and ability to meet FDA requirements- Ran affinity chromatography experiments on Agilent's AssayMAP Bravo - Ran bead-based immunocapture experiments on Thermo Scientific's KingFisher- Ran immunogenicity assays using Meso Scale Discovery Electrochemiluminescence- Ran pharmacokinetic assays using SpectraMAX ELISA

Lawrence Township, Nj, Us

- Developed and optimized ligand binding assays to evaluate the immunogenicity of a protein biotherapeutic- Evaluated emerging technologies and assays for compliance with FDA regulatory requirements and for their ability to support clinical trials- Ran assays using Meso Scale Discovery Electrochemiluminescence, BioScale’s Acoustic Membrane Micro Particle technology, and Perkin Elmer AlphaLISA technology- Contributing author to the publication "Generic Anti-PEG Antibody Assay on ProterixBio’s (Formerly BioScale) ViBE Platform Shows Poor Reproducibility" (AAPS Journal, April 2018)

- Obtained and processed information necessary to admit or register emergency room patients- Greeted and assisted patients in a timely and courteous manner- Handled urgent emergencies quickly without compromising patient health or safety- Practiced compliance with HIPPA to protect patient information and ensure each patient received equal and adequate treatment- Completed training and certification in FEMA Incident Command System (IS-00100.hcb) and National Incident Management System (IS-00700.a)

Chicago, Illinois, Us

- Refereed competitive league and cup soccer games- Enforced the rules of the game and ensured player safety at all times- Handled disputes between players, coaches, and spectators in a professional manner

Master Of Engineering (Meng), Biomedical Engineering

Bachelor Of Science (Bs), Biological Engineering

High School Diploma & International Baccalaureate Diploma