Yi Zhu
Acton, MA *****
781-***-****/978-***-**** ***********@*****.***
SUMMARY
Clinical Data Manager with strong research and nursing skills.
Experienced in biochemical, cellular and assay work and able to perform
analysis reproducibly and accurately. Knowledgeable in various
regulation, standards and assay protocols. Good attention to
documentation and organization of scientific data. Excellent skills in
using Excel and database software tools.
PROFESSIONAL EXPERIENCE
KRIGER RESEARCH CENTER INC. Huntsville, Canada 2010
(Contract research Organization)
Clinical Data Manager (Intern)
Double-blind, controlled Phase II study (Randomized comparative method,
multi-center study - 600 patients at 30 centers).
. Implemented knowledge of ICH GCP (Good Clinical Practice).
. Reviewed data for inconsistencies and errors according to the Data
Management Plan.
. Generated data listings using both ad hoc and standard queries and
reports. Designed CRFs and sent draft CRFs for review. Generated data
change forms (DCFs).
. Participated in protocol development, preparing CRF-s (Case Report
Forms), and reviewing inform consents forms.
. Worked on Research Site Evaluation Form.
. Demonstrated solid understanding of statistical analysis and quality
control processes.
. Created database for CRF-s and conducted double clinical data entry.
WYETH / PFIZER PHARMACEUTICALS, Cambridge, MA 2000 - 2010
Scientist II 2007 - 2010
. Developed and performed critical in vitro and ex vivo biochemical, cell-
based, and whole-blood assays to analyze pharmacological activities for a
number of kinase inhibitors (IRAK4, TPL2, MK2, IKK-beta) during Discovery
and early development stages. My assay data have been critical in the
decision-making of several kinase inhibitor projects.
. Performed biochemical studies to further elucidate the molecular
mechanism of action of drug candidates including an IRAK4 inhibitor.
Research Associate II 2004 - 2006
. Conducted cell-based and whole blood assays (in vitro and ex vivo) using
various biochemical techniques (ELSA, MSD, FLIPR, etc) to support
preclinical development and phaseI&II clinical trials of a TNF-alpha
converting enzyme (TACE) inihitor.
. Recognized for high-quality assay results by an Above and Beyond Award.
Research Associate I 2001 - 2003
Supported multiple protein target discovery and validation projects (TPL2
etc.) by performing critical molecular biology experiments including DNA
cloning, PCR, cell transfection, small-scale protein expression and
purification, western blotting, ELISA, isolating monocyte and PBMCs from
human whole blood and 'buffy coat'.
WYETH/GENETICS INSTITUTE, Cambridge, MA
2000-2001
Clinical Data Manager
. Reviewed clinical database to ensure accuracy, reliability, integrity,
consistency and completeness of whole database.
Yi Zhu Page Two
GENETICS INSTITUTE (continued)
. Resolved discrepancies and unresolved issues during data entry.
. Reviewed CRF-s collected from research sites.
. Performed Serious Adverse Event reconciliation.
. Identified areas of manual data review where electronic checks
ineffective.
. Reviewed data according to data management plan, including generation of
queries and review of data listings.
. Coded medical history, adverse events and concomitant medications using
dictionaries specified by each project.
VICTORIA HEALTH CENTER, San Francisco, CA 1997 - 1998
Licensed Practical Nurse
. Supervised Certified Nursing Assistant for patient care including
assessment, planning, implementation, evaluation and documentation of
nursing care.
. Administered medications according to nursing / unit policy without
errors 100%.
. Provided efficient and effective care with physician guidance.
. Evaluated and documented patient care outcomes.
. Monitored patient satisfaction and developed appropriate interventions.
HEFEI HOSPITAL OF INFECTIOUS DISEASES, HeFei, China 1988 - 1993
Registered Ward and Clinical Nurse
. Nursed multiple infectious diseases including hepatitis, cirrhosis,
measles, mumps and encephalitis.
. Assisted physicians during treatment and examinations.
. Developed and managed nursing care plan. Managed patient admission,
discharge and transfer.
. Administered oral medication and injections including IM, IV, SC, and
intradermal.
. Performed enema, catheterization and gastrointestinal intubation,
recording intake and output.
. Delivered oxygen therapy and checked vital signs (T, P, R and Bp).
. Perform wound care and cardiopulmonary resuscitation (CPR).
. Nursed terminal care patients.
EDUCATION
Certified Client / Server Application Developer, Boston University, MA,
2002
One-year Oracle and Microsoft Solutions Developer program includes hands-on
course training on HTML, JavaScript, Visual Basic 6.0, Oracle 8.0,
PowerBuilder7.0, and ASP with VBScript
BS, Nursing Program, Hefei Health Institute, Hefei, China
PROFESSIONAL CERTIFICATE
Data Management Program + GCP, GDMP Certificate Kriger Research Center,
2010
Registered Nurse, China
LPN / LVN (licensed vocational nurse) license No. VN 179548 State of
California
Education equivalence report from CGFNS (Commission for Graduates of
Foreign Nursing Schools, Philadelphia)
Certificate, Clinical Data Management Course 2000, Georgetown University
Washington, DC
Certificate, Clinical Research Program, Massachusetts Biotechnology
Council, 2000
Yi Zhu Page Three
PUBLICATIONS
. Adrian Huang, Diane Joseph-McCarthy, Frank Lovering, Linhong Sun, Weiheng
Wang, Weixin Xu, Yi Zhu, Yuhua Zhang, Steve Tam and Jeremy I. Levin.
Structure-based design of TACE selective inhibitors: Manipulations in
the S1' - S3' pocket. Bioorg Med Chem. 2007 Sep 15; 15(18):6170 - 81.
. Zhang C, Lovering F, Behnke M, Zask A, Sandanayaka V, Sun L, Zhu Y, Xu W,
Zhang Y, Levin JI. Synthesis and activity of quinolinylmethyl P1' alpha-
sulfone piperidine hydroxamate inhibitors of TACE., Bioorg Med Chem Lett.
2009, 19(13), 3445 - 8.
. Lombart HG, Feyfant E, Joseph-McCarthy D, Huang A, Lovering F, Sun L, Zhu
Y, Zeng C, Zhang Y, Levin J. Design and synthesis of 3, 3-piperidine
hydroxamate analogs as selective TACE inhibitors. Bioorg Med Chem Lett.
2007, 17(15), 4333 - 7
. Park K, Aplasca A, Du MT, Sun L, Zhu Y, Zhang Y, Levin JI. Design and
synthesis of butynyloxyphenyl beta-sulfone piperidine hydroxamates as
TACE inhibitors. Bioorg Med Chem Lett. 2006, 16(15):3927 - 31.
. Zhang Y, Hegen M, Xu J, Keith JC Jr, Jin G, Du X, Cummons T, Sheppard BJ,
Sun L, Zhu Y, Rao VR, Wang Q, Xu W, Cowling R, Nickerson-Nutter CL,
Gibbons J, Skotnicki J, Lin LL, Levin J. Characterization of (2R, 3S)-2-
([[4-(2-butynyloxy)phenyl]sulfonyl]amino)-N,3-dihydroxybutanamide, a
potent and selective inhibitor of TNF-alpha converting enzyme. Int
Immunopharmacol. 2004, 4(14), 1845 - 57.
MEETING POSTERS
. Henry-Georges Lombart Jeff Condon, Yi Zhu, Eric Feyfant, Adrian Huang,
Diane Joseph-McCarthy, Jeremy Levin, Frank Lovering, Jerauld Skotnicki,
Linhong Sun, Steve Tam, Weixin Xu, Congmei Zeng, and Yuhua Zhang.
Synthesis of Selective and Potent TACE (TNF-a Converting Enzyme)
Inhibitors. 2005 Pharmadiscovery in Washington.
. Alexis Asplasca, Jeffrey S. Condon, Eric Feyfant, Yi Zhu, Diane Joseph-
McCarthy, Jeremy Levin, Frank Lovering, Henry-Georges Lombart, Kaapjoo
Park, Jerauld Skotnicki, Linhong Sun, Qin Wang, Weixin Xu, Congmei Zeng,
and Yuhua Zhang. An exploration of the TACE P1 pocket, attempts toward
achieving selectivity over MMP family members. 2006 ACS conference.
. Diamantidis, Jeremy Levin, Zhong Li, Frank Lovering, Weiheng Wang, Jeff
Condon, Mark Behnke, Jerry Skotnicki, Diane Joseph-McCarthy, Eric
Feyfant, Yuhua Zhang, LinHong Sun, Yi Zhu, Vik Rao, Mike Krashes, and
Gabriel Berstein. BETA-SULFONAMIDE INHIBITORS OF TACEA: Design,
Synthesis and SAR of the PRE-development FO WAY-281418. Chemical
Sciences Symposium 2005 (September 26 - 28) at Cambridge, MA.
. Adrian Huang, Jeff Condon, Diane Joseph-McCarthy, Yi Zhu, Jeremy Levin,
Henry-Georges Lombart, Frank Lovering, Vik Rao, Linhong Sun, Qin Wang,
Weiheng Wang, Weixin Xu, Congmei Zeng, and Yuhua Zhang. Structure-Based
Design and Synthesis of Selective and Potent TACE Inhibitors AAPS
conference in Phila, April 2004.
. Chunchun Zhang, Jeremy I. Levin, Frank Lovering, Mark Behnke, Kaapjoo
Park, A. M. Venkatesan, Linhong Sun, Yi Zhu, Weixin Xu, and Yuhua Zhang.
TACE inhibitor for RA ACS poster, Aug, 2005.
. Chunchun Zhang*, Frank Lovering, Mark Behnke, Arie Zask, Vincent
Sandanayaka, Linhong Sun, Yi Zhu, Weixin Xu, Yuhua Zhang, Jeremy I.
Levin. Synthesis and Activity of Quinolinylmethyl P1' ?-Sulfone
Piperidine Hydroxamate Inhibitors of TACE, BMCL 2009.
. L. Nathan Tumeya; Vik Rao; Yi Zhu; Eric Bennettc; Niala Bhagiratha; Joan
Chena; Marianne Donnellyd; Katherine Leed; Henry-Georges Lombart; d;
Elizabeth Murphyb; Nikolaos Papaioannoud; Subarna Shakyab; Marina Shen;
Jae Shima; Richard Vargasd. Progress in the Development of two series of
IRAK4 inhibitors as inflammation modulators. Wyeth Annual Discovery
meeting, April 26 - 28, 2009.