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Project Medical

Location:
Cupertino, CA, 95014
Posted:
August 30, 2012

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Resume:

Lei Xu, MD, MS

***** ********** ***., #****

Cupertino, CA 95014

C: 650-***-****

swq1y7@r.postjobfree.com

OBJECTIVE

To join and contribute to a clinical development team or clinical research team.

SUMMARY OF EXPERIENCE

1. Two years of drug safety experience.

2. Seven years clinical practice experience.

3. Ten years pre-clinical research experience.

4. Completed certificate program in foundations of clinical research.

5. Knowledge of FDA regulations, Good Clinical Practice (GCP), and ICH guidelines.

6. Two years Stanford University Medical Center Post-doctoral fellow.

7. Trained for case processing and narrative writing.

8. Motivated, hardworking, team player with excellent communication/organization skills. Ability to learn and utilize new techniques quickly and accurately.

9. Proficient in Microsoft Word, Excel, PowerPoint, and Adobe Photoshop.

10. Ten years experience of writing and presenting research report at group meeting.

THERAPEUTIC EXPERIENCE

1. Central Nervous System Diseases (CNS) including Epilepsy, Headaches, Migraine and Cluster Headaches, Parkinson’s disease, Alzheimer's Disease, Strokes, Cerebral Ischemia, Dementia, Meningitis, and Multiple Sclerosis.

2. Oncologic Diseases including Brain Cancer (Brain Tumor), Breast Cancer and Lung Cancer.

3. Cardiovascular Disease including Hypertension, and PAH.

4. Immunology/Infectious Diseases including Common Cold, Influenza, Hepatitis B.

5. Endocrinology including patient assessments and treatment for Diabetes.

6. Rheumatology including Rheumatoid Arthritis.

7. Pulmonary/Respiratory Diseases including Asthma and Pneumonia.

WORK EXPERIENCE

02/2012-Present

Drug Safety Associate

Genentech Inc.

Searching Adverse Event in the cases from case management system and SPOC system; entering the Adverse Event to drug safety IRT system; searching the drug safety database; IRT Preparation. GIRA Preparation; search the drug safety database; Communication with medical site.

01/2009-04/2010

Safety Specialist

Drug Safety & Public Health Department

Gilead Sciences, Inc.

1. Contributed as a member of the Core Coding Team, ensuring coding of serious adverse event (SAE), adverse event (AE) and medication terms for clinical, spontaneous and post-marketing data using the MedDRA and WHO Drug coding dictionaries with dsNavigator and ARISg;

2. Worked on ad hoc special projects, such as AE and WHO Drug coding reviews.

3. Developed special MedDRA searches term for special event searches and data analysis;

4. Worked with the Risk Management team to identify adverse event signals and trends;

5. Worked on up-versions for search term lists;

6. Contributed on up-versions of MedDRA dictionary; Working with Information Technology to ensure efficient and effective maintenance and upgrading of coding dictionaries;

7. Worked with Clinical Data Management (CDM) to ensure timely completion of coding jobs.

8. Trained for case processing and narrative writing.

4/2007-10/2007

Research associate

Amgen Inc.

Participated in Antibody engineering project and Adiponectin protein engineering.

2/2005-03/2007

Research Associate

Rigel Pharmaceuticals, Inc.

Worked on drug Discovery Project.

5/2004-10/2004

Cell Genesys, Inc

Research associate

Participated in gene therapy project on tumor Angiogenesis.

6/2001 – 4/2003

Research Associate

Sangamo Biosciences, Inc.

Richmond, CA

1. Participated in gene therapy projects on cardiovascular therapeutic team (angiogenesis);

2. Contributed project team member during the weekly project team meetings, wrote protocols, wrote and present research reports;

7/1987 - 12/1995

Resident, Chief Resident and Attending Physician

Shanghai 6th People’s Hospital

Seven years clinical practice experience on:

1. Central Nervous System Diseases (CNS) including Epilepsy, Headaches, Migraine and Cluster Headaches, Parkinson’s disease, Alzheimer's Disease, Strokes, Cerebral Ischemia, Dementia, Meningitis, and Multiple Sclerosis.

2. Oncologic Diseases including Brain Cancer (Brain Tumor), Breast Cancer and Lung Cancer.

3. Cardiovascular Disease including Hypertension, and PAH.

4. Immunology/Infectious Diseases including Common Cold, Influenza, Hepatitis B.

5. Endocrinology including patient assessments and treatment for Diabetes.

6. Rheumatology including Rheumatoid Arthritis.

7. Pulmonary/Respiratory Diseases including Asthma and Pneumonia.

EDUCATION

4/2009

Completed the MSSO Course of Coding with MedDRA.

Completed the MSSO Course of Advanced Coding: Coding conventions and the MedDRA Points to Consider Document.

Completed the MSSO Course of MedDRA: Safety Data Analysis and SMQs.

6/2003

Certificate Program: Foundations of Clinical Research, Center for Clinical Research Practice (CCRP) and Unitek, Fremont, CA

7/1999 - 6/2001

Post-doctoral fellow

Stanford University Medical Center

Dept. of Neurosurgery, Stanford University

1. Worked on the gene therapy project for brain tumors (Oncology);

2. Worked on neuronal transplantation project for Parkinson's disease;

1/1996 - 5/1999

Master of Science, Biology

University of South Alabama

Established Expertise in cellular and molecular biology approaches to study the effects of antisense Beta globin RNA transcripts on Gamma globin production, and potential applications for anemia gene therapy.

9/1981-6/1987

Doctor of Medicine

Fudan University Medical School, Shanghai (Shanghai Medical University)

Completed all the courses and established expertise on clinical practice.

PUBLICATIONS and ABSTRACTS

Rebar EJ, Huang Y, Hickey R, Nath AK, Meoli D, Nath S, Chen B, Xu L, Liang Y, Jamieson AC, Zhang L, Spratt SK, Case CC, Wolffe A, Giordano FJ. Induction of angiogenesis in a mouse model using engineered transcription factors. Nature Medicine, 2002, 8(12): 1427-32

Williams, Z., Tse, V., Hou, L., Xu, L., and Silverberg, G., Sonic hedgehog promotes. proliferation and tyrosine hydroxylase induction of postnatal sympathetic cells in vitro. Neuro Report, 2000, 11(15):3315-3319.

Xu, L., A.E.Terry, C. Monteiro, & B.S.Pace. Enhanced Gamma globin biosynthesis by antisense beta globin RNA transcripts. Gene Therapy, 2000, 7:438-444.

Xu, L., & B.S.Pace. 1998. Modulated human globin gene expression: Role of antisense expression vectors. Cell. Mol. Bio. Letters, 1998, 3:423-433.

Edward JR., L. Zhang, Y. Lee, Y. Liang, L. Hinh, B. Johnstone, L. Xu, CL. Dent, P. Liu, X. Li, TD. Schaal, EJ. Wolffe, SK. Spratt, J. Rokovich, CC. Case, CO. Pabo. Robust Activation of Vascular Endothelial Growth Factor-A Using Designed Zinc Finger Protein Transcription Factors. The 6th American society of gene therapy, May, 2003, Washington, DC

Xu, L., C. Monteiro, and B.S.Pace. Suppression of human Beta globin chain synthesis mediated by a mammalian antisense expression vector. Presented at the American society of gene therapy, May, 1998, Seattle, WA

Xu, L., Ferry, Monteiro, and B.S.Pace. Inhibition of Beta globin gene translation using antisense RNA transcripts. Presented at the American Society of Hematology. December 1998, Miami, FL



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