Xiaofang Li

** ********** ** ***: 978-***-****

Scotch Plains, NJ, 07076 Email:

acgjh8@r.postjobfree.com

Career Summary

A research scientist with 10 years experiences in drug development R&D from

drug discovery to clinical phases in major pharmaceutical companies. Solid

knowledge and training of preclinical and clinical drug development.

Extensive experiences in preclinical and regulated documentations.

Professional Experience

Clinical, preclinical and discovery experience in Merck & Co Inc

. Scientist, Clinical Development Lab, Merck, NJ, Apr 2013-Present

-Supported phase I clinical studies, provided clinical pharmacokinetic (PK)

and biomarker data to project team, research scientific publications, write

scientific abstracts, presentations, and manuscripts

-Issued clinical study protocols (CSP), SOPs, method validation reports,

and clinical data/study reports (CSR) in a timely fashion

-Good understanding of regulatory documents and templates

-Working knowledge and training of electronic document management system

-Worked with external partners through email, teleconference or team sites,

made sure of smooth transitions and communications with external partners

or different internal sites

-Provided guidelines and SOPs to CROs. Performed data auditing and ensured

data qualities

-Conducted scientific literature search, drafted scientific manuscripts,

posters, and presentations

-Knowledge of GCP and GLP guidelines

. Scientist, Preclinical DMPK, Merck, NJ, Apr 2006-present

-Supported screening drug discovery PK/PD studies and PCC packages, drafted

IND reports for submission, investigator's brochure, and technical reviews

for multiple projects

-Coordinated and worked with CROs for outsourced discovery projects.

Responsibilities include domestic/international shipment, coordinated with

external partner through team sites and teleconferences, and data auditing

-Deep understanding of a broad spectrum of scientific data such as PK/PD,

plasma protein binding, toxicology, PGP, drug-drug interaction,

formulations

Clinical and preclinical experience in Eisai Research Institute

.Research Scientist, Drug Discovery and Disposition, Eisai Research

Institute, MA, Apr 2004-Apr 2006

-Supported early phase clinical PK studies, provided clinical PK data and

report to project team

-Worked under regulated environment. Direct interacted with investigation

sites for study details and timelines

-Drafted SOPs, validation reports, and IND reports

Other Qualifications

-Essential Skills certificate from American Medical Writer Association, Oct

2014

-Six sigma yellow belt certificate

-Work in team and matrix environments

-Regularly volunteer at Children's hospital and work closely with medical

professionals

-Excellent writing, reading, and verbal communication skills

-Very amicable and pleasant personalities

-Strong organization skills, focus on timeline, and very detail oriented

Education

- Aug 2004, M. S. in Chemistry, University of Texas, Arlington, TX

- Jul 1998, B. S. in Chemistry, Nankai University, Tianjin, China

Status

-US citizen

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