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SENIOR PRINCIPAL SCIENTIST AND SR. CONSULTANT Resume Example

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SENIOR PRINCIPAL SCIENTIST AND SR. CONSULTANT
Summary
SENIOR PRINCIPAL SCIENTIST - Skilled and highly trained molecular pathologist with over thirteen years of biopharmaceutical preclinical and translational medical research experience and proven ability to lead preclinical animal model PD/PK/EF studies, early clinical study design and clinical companion diagnostic biomarker development .
Skills
  • Led preclinical animal model development and biomarker design, PD/PK/EF studies
  • Experienced Molecular Pathologist
  • knowledgeable in using preclinical in vivo model data to drive drug into clinical
  • Successfully led collaboration with multidisciplinary project teams and managed CRO


  • Good tracking record in new assay development to  support oncology and immuno-oncology research projects
  • Lead author on scientific publications
  • Skilled in advanced molecular pathology techniques 
  • Extensive biopharmaceutical industry experience over 13 years and group leader for 8 years. 
Accomplishments
  • Developed new TSA platform for clinical trial studies and lead author of  publication in J. Biomarker (2016).
  • Developed pSYK assay for companion diagnostic biomarker development and filed a patent as co-inventor.
  • Developed PBMC IHC technique and successfully pushed the assay into AML clinical trail for patient selection and PD study.
  • Developed multiplex platform to support company-wide immuno-oncology projects.

Experience
SENIOR PRINCIPAL SCIENTIST AND SR. CONSULTANT
January 2017 to CurrentOutdo Biotech USA － Boston, MA
  • In charge of establishing a Molecular Pathology CRO laboratory in Boston area to support pharmaceutical and research organization preclinical and clinical research works.
  • Performed bio-sample requisition, provided general and customized TMAs, histology work, IHC, multiplex IHC, IF, ISH, FISH, RNAscope, image analysis and pathology consultation to support PD studies, early clinical biomarker development for novel compound indication selection, companion diagnostic biomarker development and other research projects.
  • Advised Shanghai Outdo Biobank on advanced U.S. research techniques and standards.
SENIOR SCIENTIST II
August 2011 to December 2016Takeda Pharmaceutical Company － Cambridge, MA

  • Led preclinical animal model development, PD/PK/EF studies, piloted the creation of precision, reproducibility, and target distribution metrics on cell lines, xenograft, and human tissue.
  • Played instrumental role in designing clinical biomarkers for patient selection to support clinical trials.   
  • Led the development of new assays to support pre-clinical studies. Delivered pathology support for all research study needs.
  • Created protocols, managed and collaborated with CROs from Phase I to III clinical trials.
  • Worked with multi-disciplinary teams to design Phase I clinical trials studies and companion diagnostic biomarker development for patient selection.
  • Contributed to the success of immune-oncology projects and developed immune-oncology biomarker multi-platforms for all immune-oncology projects.
  • Lead author of scientific papers for publication.
SENIOR INVESTIGATOR and MOLECULAR PATHOLOGIST
May 2010 to August 2011Sanofi Oncology R&D － Cambridge, MA
  • Led the development and validation of molecular pathology assays to support Sanofi's Oncology Small Molecule programs.
  • Provided scientific and technical leadership in pharmacodynamics (PD) studies including analyzing laboratory analytical data and providing technical expertise.
  • Collaborated with project teams on a day-to-day basis to develop new biomarkers to support the project needs.
  • Prepared and delivered effective presentations to key project stakeholders in support of clinical trials.
  • Supported Phase I and Phase II of clinical trials and clinical biomarkers development.
  • Established and developed human tissue repository to provide genomic information and provide tumor tissue for use by external research groups.
  • Directed the launch of real-time global digital pathology connection for use by Sanofi R&D groups worldwide.
  • Instituted an oncology pathology database and a web-based image data management system.
INVESTIGATOR
November 2004 to May 2010Novartis Institute for Biomedical Research, Inc － Cambridge, MA
  • Directed preclinical PD studies to support IAP, DR5, DNMT, CDKs, Glevic, Bcl-2, and other projects.
  • Delivered medical monitoring and implementation of development programs for research pipeline molecules.
  • Performed clinical trial development and execution to ensure resource efficient drug development programs.
  • Provided clinical and scientific input into discovery research and early development activities.
  • Executed pre-clinical translational research projects aimed at expanding immunocytochemistry applications.
  • Assisted in the development of a scientifically rigorous early clinical development plans.
  • Supported both large and small molecule drug discovery and development, from high throughput technologies to unique specialized analytics to answer project specific questions.
  • Partnered with biometrics and clinical operations to ensureclinical operations and development program success.
  • Advised on translational medicine approaches that mitigated risk while ensuring and validating the mechanism of action, safety, and development plan for early drug development.
SENIOR PATHOLOGY TECHNOLOGIST
January 2002 to November 2004ST. ELIZABETH'S MEDICAL CENTER － Boston, MA
Lab manager for IHC CLIA certified Lab.
Education and Training
Cell Biology, 2012Harvard Medical School － Boston, MA, USA
Ph.D. : Cell Biology, 1996University of Hong Kong － Hong Kong, China
M.D. : Medicine, 1982Ningxia Medical School － Niningxia, China
Activities and Honors
Board certification in clinical pathology in China
Key Words
Clinical research , data management,   Preclinical and clinical study designing, drug development, Image analysis, Management, CRO, Leadership, Oncology, Pathology, Molecular Pathology, Pharmacology modeling, PD/PK/EF study,  Protocols design for preclinical and clinical study, Scientific Publication, Research,
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Resume Overview

Companies Worked For:

  • Outdo Biotech USA
  • Takeda Pharmaceutical Company
  • Sanofi Oncology R&D
  • Novartis Institute for Biomedical Research, Inc
  • ST. ELIZABETH'S MEDICAL CENTER

School Attended

  • Harvard Medical School
  • University of Hong Kong
  • Ningxia Medical School

Job Titles Held:

  • SENIOR PRINCIPAL SCIENTIST AND SR. CONSULTANT
  • SENIOR SCIENTIST II
  • SENIOR INVESTIGATOR and MOLECULAR PATHOLOGIST
  • INVESTIGATOR
  • SENIOR PATHOLOGY TECHNOLOGIST

Degrees

  • Cell Biology , 2012
    Ph.D. : Cell Biology , 1996
    M.D. : Medicine , 1982

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