Project Manager Clinical Research
Resume:
Christine Hopf
**************@***.***
Pharmaceutical scientist with greater than 20 years of experience, specializing in Oncology
Excellent organizational and managerial skills, including experience in managing CROs.
Able to handle large volumes of work at one time while remaining goal oriented
knowledge of drug development, GLP, GCP/ICH, and FDA guidelines as well as certification in GMP regulations
Utilization of PDX models for standard of care modeling in house
Excellent team leader and player, global as well as local, very goal oriented
ACR certification from Clinical Research Academy
Excellent computer skills including Microsoft Office applications, Oracle Clinical
Able to manage cross-functional projects
Excellent support of preclinical Oncology targets to IND status, including protocol writing
Extensive laboratory experience animal experience including handling, drug delivery, necropsy, pharmacodynamics, and pharmacokinetics
in-vitro experience, including, ELISAs, flow cytometry and cell-based assays to study Oncology biomarkers
Extensive Histology including, paraffin embedding, microtome, sliding microtome, and staining
In-vivo imaging using Caliper IVIS animal imaging system
Pfizer 2014-present
Contract with Atrium Staffing
Scientist
Project manager for PDX program in house
Currently responsible for 2 employees
Set weekly schedule, including duties and workflow of project.
Goal oriented, organized and detailed oriented
Decision making for any changes that need to be made to ensure project goals are met on time
Creation of SOPs for any procedures needed on the project, internal and external
Plan Standard of care experiments, based on Clinical findings, to gain better understanding of PDX models, including data anaylisis
Collaboration with other laboratories, internal as well as external, includes contract document management, tracking of data and samples, ensuring integrity of studies
Presentation of data findings to group
Extensive work with Microsoft EXCEL, Word, Powerpoint
Hoffman LA Roche Pharmaceuticals, Nutley, NJ
Associate Principal Scientist
Pharmaceutical Research & Early Development, Department of Oncology 2008-2012
Elaborate pharmacokinetic and pharmacodynamics studies, includes planning, performing as well as data analysis.
Efficacy studies in multiple Oncology models for evaluation of compounds as monotherapy or as combination.
In vivo lead for antibody project enabling compound to be chosen for IND filing, currently in Phase I
In vivo lead for small molecule project
Evaluate completed experiments with project managers
Participate in teleconferences and local team meetings for projects as needed
Safety committee chair and member of Roche Institutional Biosafety Committee.
Highly motivated, independent researcher, team member
Wyeth Pharmaceuticals, Pearl River, NY
Research Scientist II
Tumor Biology Group, Department of Oncology 2005-2008
Established animal models for discovery oncology
Extensive In vivo techniques
Tumor cell or fragment implants and orthotopic surgical procedures.
Irradiation of animals.
Proficient in Excel, Word and Powerpoint.
Progenics Pharmaceuticals Corporation, Tarrytown, NY
Associate Research Scientist I
Tumor Biology Group, Department of Oncology 2002-2005
Radioisotope technology with in vivo and in vitro models.
Proficient in ELISAs, Biacore, cell-based assays and Westerns.
Extensive work with FACS Calibur using FlowJo and Cellquest software identifying cell surface markers as well as Cell Cycle analysis.
Substantial animal work
Experienced in mammalian tissue culture, tumor implantation, measurements, data input and analysis.
Novartis Pharmaceuticals Corporation, Summit, NJ
Scientist I
Department of Transplantation 1993 – 2001
Participate in research using in-vivo pharmacology and disease models.
In-vitro compound screening in several cell based assay systems.
Substantial animal experience and training of new employees
Extensive experience in histology
Education
A.C.R. - Clinical Research Academy, Edison, NJ (Includes CRA, CDM and Oracle Clinical training)
B.S. - Biology, Fairleigh Dickinson University, Madison, NJ
A.A.S. - Medical Laboratory Technology County College of Morris, Randolph, NJ
(includes hospital rotations in the following departments; hematology, serology, urinalysis, coagulation, clinical chemistry, microbiology, parasitology, and phlebotomy)
GMP - Hoffman La Roche, Nutley, NJ
-Caliper Life Sciences course on Working with IVIS Spectrum in vivo imaging instrument
MEMBERSHIPS
American Association of Laboratory Animal Science, National (2004-2012)
American Association for Cancer Research, Active Member (2008-2012)
PUBLICATIONS
Tovar C, Graves B, Packman K, Filipovic Z, Higgins B, Xia M, Tardell C, Garrido R, Lee E, Kolinsky K, To KH, Linn M, Podlaski F, Wovkulich P, Vu B, Vassilev LT.Cancer Res. 2013 Apr 15;73(8):2587-97. doi: 10.1158/0008-5472.CAN-12-2807. Epub 2013 Feb 11.MDM2 small-molecule antagonist RG7112 activates p53 signaling and regresses human tumors in preclinical cancer models.
Goggin B, Schutt A, Hong K, Polonskaia A, To T, Gao L, Aguilar D, Solis D, Hilton H, Hang JS, Liang Z, Fretland A, Lee K, Mischke S, Chen S, Le N, Lou Y, Remiszewski S, Tardell C, Dvorozniak M, Tannu S, Packman K, Lee EC. (2012): Novel small molecule antagonists of XIAP enhance death receptor-induced apoptosis in preclinical models of human cancer. [Submitted]
Wang H, Daouti S, Li W, Wen Y, Rizzo C, Higgins B, Packman K, Rosen N, Boylan J, Heimbrook D, and Niu H. Identification of the MEK1 (F129L) activating mutation as a potential mechanism of acquired resistance to MEK inhibition in human cancers carrying the B-RafV600E mutation Cancer Res 2011 Aug 15;71(16):5535-45.
Daouti S, Higgins B, Kolinsky K, Packman K, Wang H, Rizzo C, Moliterni J, Huby N, Fotouhi N, Liu M, Goelzer P, Sandhu HK, Li JK, Railkar A, Heimbrook D, Niu H. Preclinical in vivo evaluation of efficacy, pharmacokinetics, and pharmacodynamics of a novel MEK1/2 kinase inhibitor RO5068760 in multiple tumor models. Mol Cancer Ther.2010 Jan; 9(1):134-44.
Ma D, Hopf C, Malewicz A, Donovan G, Senter P, Goeckeler W, Maddon P, Olson W.
Potent antitumor activity of an auristatin-conjugated, fully human monoclonal antibody to prostate-specific membrane antigen. Clin Cancer Res 2006 Apr 15; 12(8):2591-6.
Weetall M, Deegan ME, Hugo R, Mathew S, Hopf C, Tart-Risher N, Zhang J, Shi V, Fu F, Hammond-Mckibben D, West S, Brack R, Brinkmann V, Bergman R, Neville D Jr, Lake P. T-cell depletion and graft survival induced by anti-human CD3 immunotoxins in human CD3epsilon transgenic mice. Transplantation 2002 May 27; 73(10):1658-66.
Fu F, Hu, S, Deleo J, Li S, Hopf C, Hoover J, Wang S, Brinkmann V, Lake P, and Shi VC. Long-term Islet Graft Survival In Streptozocin- And Autoimmune-Induced Diabetes Models By Immunosupressive And Potential Insulinotropic Agent FTY720. Transplantation 2002 May 15; 73(9):1425-30.
POSTER PRESENTATIONS
Rizzo C, Yin X, Packman K, Higgins B,3 Schnueriger A, Thomas M, Weidner M, Heimbrook D and Simcox M Hoffmann-La Roche Inc. Discovery Oncology, Nutley, NJ 07110, Discovery Oncology, Penzberg Germany, Analytical R&D Biotech, CH-4070, Basel Switzerland RO5323441, a humanized monoclonal antibody against the placenta growth factor, blocks PlGF-induced VEGFR-1 phosphorylation in vitro and tumor growth in vivo. 101st American Association for Cancer Research (AACR), Washington, D.C., April 2010
Boschelli F; Chen L; Tkach D; Golas G; Baxer M; Yang S; Rizzo C; Gruzas J; Boghaert E; Discafani C; Vultur A; Jove R; Arndt K. Wyeth Pharmaceuticals, Pearl River, NY Re-establishment of cell-cell contacts and beta-catenin membrane localization in Colo205 colorectal tumor cells treated with the Src inhibitor bosutinib (SKI-606). American Association for Cancer Research (AACR), Los Angeles, CA, April 2007
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