Clinical Scientist/Clinical Research Manager

Lixin Jiang

*** ***** ****, *********, ** *****

609-***-**** (C), 609-***-**** (H)

Email: *****.*****@*******.***

SUMMARY:

Senior research scientist with extensive knowledge in Drug R&D

GCP guideline trained clinical trial and safety monitor scientist for four years in Cardiovascular diseases, Gastroenterology, Oncology and post market medical device safety monitoring, contributed in getting medicine and medical devices into market

Medical background, very good knowledge in medical terminology and human diseases

17 years in drug discovery, biomarker research and advanced biotech in Neuroscience, Cardiovascular & Metabolic diseases, contributed in getting compounds into IND

Expertise in clinical database review/query, site operation, trial coordination, safety monitoring, data statistic processing, query resolving, timeline driving, communication to stakeholders, report generation and medical writing

Excellent computer skills: MS Suite (Excel, Word, Access, PP, etc), Oracle database, SAS/STAT, certain extent of Bio-informatics and IT skills

Outgoing personality with excellent communication, interpersonal and presentation skills, organized with attention to details, functions well in multi-disciplinary environment, strategic and analytical thinking, excellent team builder, open-minded, fast learner, with leadership ability

EDUCATION, CERTIFICTE AND TRAININGS:

BSMD Beijing University, School of Medical, Beijing, China

MS Pathology, School of Medicine, SUNY at Buffalo, NY

USMLE Passed part I and II (US Medical License Exams)

CRA and GCP Kriger Research Group International

Drug Development Courses from Kriger Research Group International with GCP training

Dale Carnegie Training in Effective Communications & Human Relations

Wyeth Training in Business Writing; Presentation Skills; Diversity Workshop; and Team Leader Training Program

PROFESSIONAL EXPERIENCE

Senior Research Scientist II, Neuroscience R&D, Pfizer/Wyeth, 2003-2010

Was one of the key persons in clinical databases study and adverse-event monitoring for clinical safety biomarker hunting in Psychiatric diseases treatment. Reviewed and mined clinical database and adverse event case reports with great dedication and excellent medical knowledge. Extracted safety data, correlated adverse events vs. medications. Queried data and statistically processed data. Extensively studied biomedical literatures for leads verification. Identified biomarkers vs. certain drug adverse effects and validated them in animal models and clinical data from patient treated with certain anti psychiatric drugs. Generated summaries and wrote up reports. Presented results and shared ideas to team members and at monthly meeting with stakeholders. Great team player resulted a novel biomarker identified in this project, which would be utilized in clinical safety monitoring one of the most frequent adverse effects in the treatment of Schizophrenia. Patent filing and scientific publications are in process.

Played a crucial role in discovering new drug treatment for Schizophrenia and Alzheimer’s disease by working with external alliances internationally and internal collaborators at site. Responsible for driving timelines, reviewing/querying data generated by alliances, oversaw data quality and integrity according to SOP and GLP, uploaded data into database and maintained database. Site visit and teleconference communication regularly. Ensured regulations compliance. Made summaries and presentations to managers and government bodies for portforlile review. Great teamwork made three novel compounds moved into IND from collaborations. Achievements and contributions were recognized with Wyeth Excellence Award and promotion.

Worked on several side projects to understand the mechanism of schizophrenia. Co-authored five scientific papers in prestigious journals, including Nature of Neuroscience and PNAS.

Senior Research Scientist I, Transcriptional profiling, Neuroscience, Wyeth 1998-2002

One of the most pioneer people in Transcriptional Profiling technology in Wyeth, resulted a state-of-art Transcriptional Profiling Core Laboratory serving Neuroscience on-site in searching biomarkers and novel therapeutic targets in various psychiatric and neuro-degenerative diseases. Showed leadership ability on managing laboratory routines and reagents supplies, training junior staffs, organizing meetings. Communicated with clients regularly.

Transcriptional profiling studied Schizophrenia and Major Depression of human brains from Stanley Foundation and collaborated with medical doctors and clinical scientists in NIH and informaticians and statisticians internally. Performed genetic profiling of different regions of human brain at RNA level by using AffyMetrix micro array system, data generation and annotation. Leads identification and validation, database mining and bioinformatics studies. Three patents on biomarkers were filed and three research papers were published in this project.

Research Scientist III, Department of Cardiovascular and Metabolic Diseases, Wyeth 1993-1998

Studied safety and efficacy of compound leads in animals with hypolipidemic drugs. Responsible for monitored blood lipid changes, drug safety profiles and PK/PD studies.

Clinical Research Coordinator and post market Safety Monitor Associate, Cardiovascular Diseases, Thomas Jefferson University, Philadelphia, Pa. 1992-1993

Post market medical device safety monitoring on restenosis of coronary artery post percutaneous coronary artery angioplasty in treatment of coronary artery disease. Responsible for:

Protocol review, CRF review and project planning and execution

Collaborated different functional areas for complicated heart function and blood vessel measurements in patients, monitored and reported adverse events

Managed site operations, communicated with investigators, patients and sponsor, wrote memos, reports and documents in accordance with internal SOPs

Oversaw data collection, review, validation and query resolution to ensure data’s quality and integrity;

Hosted and participated in project meetings and provided the team with trial progress to ensure study timeline and milestones on-track; followed up on action items

Clinical Research Coordinator, Oncology, Buffalo General Hospital, SUNY at Buffalo, Buffalo, NY 1990-1991

Managed a Phase II clinical trial on retinol acid in treating acute leukemia. Responsible for patient enrollment, CRF data queries, adverse event monitoring and reporting, preparing tabulated clinical data in excel spreadsheets for Investigators. Also maintained clinical databases and presented data to study team.

Clinical Research Associate, Gastroenterology, Children’s Hospital of Buffalo, SUNY at Buffalo, NY 1986-1988

Worked on WHO (World Health Organization) sponsored trial on Home-Prepared Oral Rehydration Supplement Solution to treat children’s dehydration in acute diarrhea in developing countries. The primary objective of the trial was to evaluate the effectiveness of treating dehydration during acute diarrhea in children with an easy access and easy storage dry power package containing pancreatic enzymes and supplement salts for home preparation of oral rehydration solution with rice by care givers in remote areas. Responsible for data collection, review, validation, and uploading into database. Trial was run internationally in Indonesia, Thailand and other developing countries.

MEMBERSHIPS:

Society for Neuroscience since 1996

AAAS since 1996

OTHER ACTIVITIES

Co-organized annual “Bring Kids to Work Day” in company

Volunteered in company’s annual “Bring Science to Community” since 2004; activities included lectures and on site research demos for local middle or high school students

Taught Chinese in regional non-profit Chinese School at weekends

PUBLICATIONS:

1. Charych EI, Jiang L-X, Lo F, and Brandon NJ. N-terminal Palmitoylation of PDE10A2 is regulated by PKA phosphorylation and is required for plasma membrane localization. The J. of Neuroscience 2010, in press.

2. Kelly MP, Logue SF, Brennan J, Lakkaraju S, Jiang L, Rizzo S, Platt BJ, Dwyer JM, Neal S, Pulito VL, Grauer S, Navarra RL, Kelley C, Comery TA, Murrills RJ, Brandon NJ (in press). Phosphodiesterase 11A (PDE11A) in brain is enriched in ventral hippocampus and deletion results in schizophrenia-related phenotypes. PNAS 2010, MS#2010-00730.

3. Feng Liu, Robert L. Arias, Guoming Zhang, Raquel Revilla-Sanchez, Lixin Jiang, Amy Sung, Ronald F. Mervis, Rachel Navarra, Stephen J. Moss, Menelas N. Pangalos and Nicholas J. Brandon. Activation of estrogen receptor-β decreases phosphorylation of translation initiation factor eIF2α and regulates synaptic plasticity. (under review by Nature of Neuroscience).

4. Steven M. Grauer, Virginia L. Pulito, Rachel Navarra, Michele Kelly, Cody Kelley, Radka Graf, Barbara Langen, Sheree Logue, Julie Brennan, Lixin Jiang, Erik Charych, Ute Egerland, Feng Liu, Karen Marquis, Michael Malamas, Thorsten Hage, Thomas A. Comery and Nicholas J. Brandon. Phosphodiesterase 10A Inhibitor Activity in Preclinical Models of the Positive,Cognitive, and Negative Symptoms of Schizophrenia. The Journal of Pharmacology and Experimental Therpeutics (in press).

5. Heinrich JN. Brennan J. Lai MH. Sullivan K. Hornby G. Popiolek M. Jiang LX. Pausch MH. Stack G. Marquis KL. Andree TH. Aplindore (DAB-452), a high affinity selective dopamine D2 receptor partial agonist. [Journal Article] European Journal of Pharmacology. 552(1-3):36-45, 2006 Dec 15.

6. C. Aston, L. Jiang, B.P. Sokolov. Microarray analysis of postmortem temporal cortex from patients with schizophrenia. J Neurosci Res. 2004 Sep 15; 77(6): 858-66.

7. C. Aston, L. Jiang, B.P. Sokolov. Transcriptional profiling reveals evidence for signaling and oligodendroglial abnormalities in the temporal cortex from patients with major depressive disorder. Mol Psychiatry. 2004 Aug 10: 1-14.

8. B.P. Sokolov, L. Jiang, N.S. Trivedi, C. Aston. Transcriptional profiling reveals mitochondrial, ubiquitin and signaling systems abnormalities in postmortem brains from subjects with a history of alcohol abuse or dependence. J. Neurosci. Res. 72:756-767, 2003.

9. S. Burchett, P. Flanary, C. Aston, L. Jiang, K.H. Young, P. Uetz, S. Fields, H.G. Dohlman. Regulation of stress response signaling by the N-terminal DEP (dishevelled/ EGL-10/pleckstrin) domain of Sst2, a regulator of G protein signaling in Saccharomyces cerevisiae. J. Biol. Chem. 277: 221**-*****, 2002.

10. Kenrick MK. Jiang L. Potts CL. Owen PJ. Shuey DJ. Econome JG. Anson JG. Quinet EM. A homogeneous method to quantify mRNA levels: a hybridization of RNase protection and scintillation proximity assay technologies. [Journal Article] Nucleic Acids Research. 25(14): 2947-8, 1997.

11. K.Y. Lee, L. Jiang, E. Lebenthal. Pancreatic Exocrine Enzymes During the Neonatal Period in Postmature Rats, International Journal of Pancreatology. 2:325-335, 1987.

ABSTRACTS:

1. L. Jiang, E. I. Charych, K. Chan, R. Martone, M. Kelly, F. Liu, F. Lo, U. Egerland, T. Hage, M. Pausch, N. Brandon. Understanding the role of phosphorylation, palmitoylation, and subcellular localization in PDE10a activity 155.20. SFN, Oct. 2009 Chicago, IL.

2. M. P. Kelly, S. F. Logue, J. Brennan, S. Lakkaraju, L. Jiang, E. Presman, M. Tam, S. Rizzo, B. J. Platt, J. M. Dwyer, S. Neal, V. L. Pulito, S. Grauer, R. L. Navarra, C. Kelley, A. Kramer, T. A. Comery, K. Marquis, R. J. Murrills, N. J. Brandon. PDE11a expression in the brain is enriched in ventral hippocampus and deletion results in schizophrenia-related phenotypes. 248.4. SFN, Oct. 2009 Chicago, IL.

3. F. Pruthi, Q. Wang, G. Jin, A. Sievers, A. Godbole, X. Zhong, L. Cameron-landis, R. Kriz, L. Jiang, J. Kouranova, K. Kelleher, E. Charych, M. Kelly, E. Vogan, G. Krishnamurthy, N. J. Brandon, M. H. Pausch. Characterization of localization and enzymatic properties of the Traf2 and Nck-Interacting Kinase TNIK. 249.5. SFN, Oct. 2009 Chicago, IL.

4. T. Hage, B. Langen, N. Hoefgen, H. Stange, U. Egerland, T. Kronbach, V. Pulitto, R. Navarra, M. Kelly, R. Graf, S. Logue, L. Jiang, C. Kelly, S. Grauer, B. Harrison, K. Marquis, T. Comery, M. S. Malamas, N. Brandon. PDE10a inhibitors show anti-psychotic, pro-cognitive and negative symptom activities suggesting a broad-spectrum utility for the treatment of schizophrenia, 748.6. SFN, Oct. 2009 Chicago, IL.

5. J. Heinrich, M. Lai, M. Popiolek, L. Jiang, M. Pausch, H. Mazandarani, D. Smith, G. Horby, L. Schechter, T. Wasik, G. Stack, K. Marquis and T. Andree. Pharmacological Evaluation of D2 Partial Agonists: Coupling D2Rs to Gsq/I Chemeras in CHO-K1 Cells. SFN, Nov. 2005.

6. G. Hornby, L. Jiang, B. Jow, T.H. Andree, J. Dunlop, M. Pausch, S. Grauer, K. Marquis, S. Logue. Functional Characterization of the Mouse Type I Glycine Transporter (GlyT1). SFN, Nov. 2004.

7. L. Jiang, C. Gonzales, D. Jacobowitz, M. Blatcher, M. Fennell, J.A. Moyer, M. Zaleska, C. Aston. Region-specific transcriptional profiling in a transient middle cerebral artery occlusion (MCAO) rat model of ischemia, using oligonucleotide microarrays. SFN, Nov. 2003.

8. C. Aston, L. Jiang, N.S. Trivedi, B.P. Sokolov. Genome-wide transcriptional profiling reveals common mitochondrial, ubiquitin and signaling systems abnormalities across subjects with alcohol abuse or dependence, with or without other psychiatric diagnoses. SFN, Nov.2003.

9. B.P. Sokolov, L. Jiang, C. Aston. Microarray analysis indicates altered myelination and synaptic function in schizophrenia and a possible role for epigenetic mechanisms. The American College of Neuropsychopharmacology (ACNP), Puerto Rico, December 8-12, 2002.

10. L. Jiang, H. Sugimori, I. Ay, M. Zaleska, J. Moyer, S. Finklestein, C. Aston. Transcriptional profiling of the effects of basic fibroblast growth factor (bFGF) in recovering ischemic and non-ischemic rats using oligonucleotide microarrays. XIVth World Congress of Pharmacology, San Francisco, California, USA July 7-12, 2002. #B108R.

11. L. Jiang, D.W. Dilks, H. Sugimori, I. Ay, T. Novak, K.W. Wang, J. Moyer, S. Finklestein, C. Aston. Transcriptional profiling of the effects of basic fibroblast growth factor (bFGF) in ischemic and non-ischemic rats using differential display PCR (DD-PCR) and confirmation by real-time quantitative PCR. SFN Nov. 2000.

REFERENCES: available upon request.

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