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CURRICULUM VITAE
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Address: 3-20-9 BR-ShibauraN 2 Shibaura,Minato-ku,Tokyo 108-0023
TelF03-5484-6936@@Fax: 03-5484-5924
Email: taro.yamada@bbc.com
Mobile: 090xxxxxxxxx |
SUMMARY
After getting a Master of Science Degree (M.S.) in Medical Sciences from Tokyu
University, joined Pharma Japan Co., Ltd.--currently Pharam Internaitonal.
I researched the effects and stability of various medicines in the Analytical
Science Section of the Pharmaceutical Development Dept.
I transfered to the PMS Division, where I was in charge of domestic and foreign
reports concerning adverse drug reactions.
Subsequently, I joined ABC Pharma. Ltd., where I worked in the PMS Division. |
Resume
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After graduating from Department of Hygienic Pharmacy, Tokyu University of
Pharmacy, I joined ABC Pharmaceutical Co., Ltd. Assigned to Clinical Development
Department, I consistently worked as a monitor in charge of Phase II to Phase
III for new drugs. As the company had adopted a project system, I experienced
various assignments from protocol planning to CRF preparation, DM, preparation
of submission summary, overview report and publication papers, though under the
old GCP. After introduction of the new GCP, I worked as a monitor in the cardiovascular
surgery field for 2 years. Subsequently, I moved to the unit responsible for the
overall management of basic and clinical studies. For 1 year and 3 months, I served
as an assistant to the project leader. The drug I was dealing with had been introduced
from an American venture company, and therefore, I have acquired the experience
of negotiating in English. After the management department and clinical development
department were merged, I again worked as a monitor for infective area under the
new GCP. At present, I am engaged in planning a Phase I study for an antidiabetic
drug. |
Position desired
| Clinical development staff member in a pharmaceutical company |
Professional Career
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April 199X-
Joined ABC Pharmaceutical Co., Ltd. Assigned to Clinical Development Department,
Development Division, and worked as monitor for new drugs. Drugs and studies handled
after the end of training period:
EExtension of indications of Palux, a joint development project with the former
Green Cross Corporation: Monitoring, planning, CRF preparation and DM for spinal
canal stenosis (early Phase II), and contrast radiography for superior mesenteric
artery (Phase III) Engaged in preparation of the submission dossier for Palux
in contrast radiography of superior mesenteric artery, which was approved by the
government (Development of spinal canal stenosis was discontinued.)
EAS-013 (Palux prodrug), a joint project with the former Green Cross Corporation:
Monitoring, planning, CRF preparation and DM for chronic arterial obstruction
(early Phase II) and collagenosis (Taisho Pharmaceutical withdrew from this project,
and Green Cross continued the development.)
ETTC-909, a joint project with Teijin: Monitoring for chronic arterial obstruction
(Phase III)
March 199x-
Nominated for a position in charge of development of new gastrointestinal drugs
EIT-066 (late Phase II, Phase III)
Monitoring, planning, CRF preparation and DM for gastric ulcer and duodenal ulcer
(applied but not approved)
EClarith (early Phase II)
Monitoring for eradication of Helicobacter pylori (concurrent use of two drugs)
(The regimen of concurrently using 3 drugs was adopted by the medical society,
and this development project was cancelled.)
October 199x-
ETTC-909, a joint development project with Teijin
Monitoring under the new GCP for chronic arterial obstruction (Phase III)
(In Phase III, a significant difference from placebo could not be demonstrated,
and therefore, submission was given up.)
January 200x-
Transferred to Development Promotion Department (responsible for total management
of basic and clinical studies)
EINS-1 (anti-diabetic)
Management of the project, in which negotiations with an American venture company
were handled, by attending meetings and preparing documents in English
August 200x-
Merger of clinical development department and development promotion department
EABT-773, a joint project with Dynabbott:
Monitoring under the new GCP for community acquired pneumonia (Phase IIa)
The cost of the drug substance could not be reduced, and the clinical study was
temporarily suspended.
April 200x-
TS-021
Preparation of PRT, the investigator's brochure and informed consent form, and
negotiation for manufacture of the study drug.
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ACADEMIC RECORD
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March 1989
Graduated from Regular Course, Hyogo Prefectural Hakuyo Senior High School
April 1989
Entered Hygienic Pharmacy Department, Tokyu University of Pharma
April 1993
Graduated from Hygienic Pharmacy Department, Hoshi College of Pharmacy
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Qualifications
April 1993
Passed National Examination for Pharmacist and obtained license to practice pharmacy |
Others
Birth date:June 15, 1973
Hobbies:skiing, skating, watching sport games |
Self PR
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I have been engaged in clinical studies for new drugs for the past 10 years.
Although I mostly worked for vascular surgery, I have experienced other various
fields from the time before the new GCP. I am therefore confident that I will
be able to deal with any areas. As I also served as an assistant for the total
management of basic and clinical studies, though only for a short 1 year &
3 month-period, I am able to grasp clinical studies from broad perspectives. During
the time, I negotiated with the American venture company, attending meetings,
sending E-mails and preparing documents in English. Meanwhile, I attended in-house
training sessions for medical English (10-day residential course) and English
business writing. TOEIC 750 points may not yet be sufficient for business operations
in English, but I am studying hard every day. Since I have experienced almost
all the stages of clinical development, I will be able to try my best in whatever
position I will get. |
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