Resume

Telephone#: (215) 896-0404

E-mail: zhengyl@comcast.net

Job Objective: Clinical Research and Development in the United States and/or Ch
ina and Other Asian
Countries
Summary of Experiences:
* Over 10 years' working experiences at pharmaceutical industry (Merck, Jazz, an
d Otsuka) as a medical monitor and project lead for Phase IIa and Phase III tria
ls in neuroscience;
* Over 20 years of experience in validation research of diagnosis and endpoint a
ssessments;
* Over 12 years' psychopharmacological research at NIH Research Center on the Ps
ychobiology of Ethnicity, Harbor-UCLA Medical Center in Los Angeles;
* Over 70 papers published both in international journals and in academic journa
ls in China;
* Familiarity with FDA's policies, GCP/ICH standards, Clinical trial SOPs, and r
egulatory requirements for drug development;
* Well-known professor and psychiatric researcher in China and have strong conne
ction with CNS opinion leaders in China;
* Well-demonstrated leadership and communication skills in diverse cultures;
* Self-motivated, problem-solving focused, and eager to make contribution for th
e company's development in China and other Asian countries.

PHARMACEUTICAL EXPERIENCES
Over 10-years' pharmaceutical experience in developing and monitoring clinical t
rials in CNS. Responsible for the CNS drug development, including early phase st
udies and phase II and III trials in fibromyalgia, major depressive disorder, p
rimary insomnia, ADHD, schizophrenia, bipolar disorder, and dementia of Alzheime
r's disease. Filing experiences for the indications of primary insomnia and fibr
omyalgia. Working closely with cross-functional divisions and team members to es
tablish drug development strategies.
Major responsibilities as a project leader include:
* Protocol development, site selection, provision of protocol-related trainings
in investigators' meetings
* Monitoring quality of enrollment, waivers/deviations, lab tests, AEs, and stud
y progress, conducting site visit and audit
* Working with other divisions, such as database, biostatistics, regulatory, and
quality assurance, to develop workbook, consent form, case report form, DAP, an
d respond questions to the sites, subsidiaries, IRB/IECs, and other agents

* Making strategic plans for quality and quantity of enrollment at the sites, cl
osing enrollment, clinical data review, and frozen file
* Reviewing and supervising the CSR and manuscripts for publication
* Assisting senior managers by providing dynamic projections of the enrollment a
nd evaluating quality of enrollment for the entire MK-0869 program
* Managing CROS and internal team members.
Title From - To
Sr. Director, Clinical Development 04/24/2009-Present
Project Lead for early phase compounds for the indications of MDD and Dementia o
f Alzheimer's type. Developing protocols and monitoring of phase Ib and phase I
I studies, support filing of indication of bipolar I in Japan.
Sr. Director, Clinical Development 07/01/2007 - 4/15/2009
Project Leader, Responsible for all aspects of Phase III program for the treatm
ent of fibromyalgia as assigned. Primarily responsible for the project's progre
ssion and the success of the multidisciplinary team in performing integrated and
timely functions, including working with CRO for the quality patients recruitme
nt, clinical trial completion, to data analysis, interpretation, publication, an
d NDA regulatory submissions.
.
Merck & Co., Inc.
Medical Monitor 07/01/2001 - 6/30/2007
Medical Monitor, 1) Clinical Member of experimental medicine in Early Developmen
t Team (EDT) and Therapeutic Area Group (TAG) for the drug development in sleep
medicine; 2) Clinical member for early phase study (POC) program in Asian-Pacifi
c region for CNS; 3) Medical monitor for phase II and phase III studies of Subs
tance-P antagonist for Major depressive disorder (MDD), gaboxadol program for in
somnia, including protocol development, site selection, presenting clinical stud
y in investigators' meetings, monitoring clinical trials, and reviewing CSRs; 4)
Working member for the ISS and ISE (2.7.3 and 2.7.4) development of gaboxadol p
rogram; 5) Clinical representative of Outcome Research (OR) and Market teams for
the life cycle studies and drug development.
Consultant, Pfizer Inc., 1996-1999,
Sertraline, phase IV worldwide study in fibromyalgia. Major role include formul
ated research design, validation of translation and back translation of CRF from
English into Chinese, Sponsor's invited speaker and trainer for structured diag
nostic interview and endpoint assessment training in international investigator
s' meetings.