Expert Details
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
ID: 724018
Massachusetts, USA
Expert is an expert in drug clinical development from planning to protocol design, conducting and reporting.
Drug approval regulation is complexed processes. Expert has years of experience in working on all requirements related to drug approval.
Expert has developed drug labels from draft to 1st approved label on all medical and safety related sections. He has been maintaining label updates on safety and new indications.
Expert has a working knowledge of regulations in US and EMEA is key to be successful in this field. He keeps up with all related regulations (updates) and applies those to the development programs.
Expert is working with many investigational drugs in clinical phase of development. He is an expert in the evaluation of new compounds.
Expert has been leading the efforts to file NDA for several drugs involving all the clinical aspects of the program.
Clinical drug safety is his primary focus in clinical development. Anaylsis safety information from clinical studies are part of his rountine daily life. He is leading signal detection and risk management efforts.
Expert has a working knowledge of ICH guidance related to patient protection and relevant US laws.
Expert has been working on a number of pro-drugs in clinical development with experience in special requirements in regulations and clinical development.
Participated drug evaluation meeting for in-licensing
and safety monitoring committee.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1986 | Degree: MD | Subject: Medicine | Institution: Tianjin Medical University |
| Year: 1998 | Degree: PhD | Subject: Cardiology and Immunology | Institution: Temple University School of Medicine |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to 2012 | Employer: Sanofi-Aventis | Title: Sr. Medical Director | Department: Medical Affairs, Oncology |
Responsibilities:working with marketing/brand team on marketing strategies. working with internal clinical team for clinical studies. working with KOL for medical education. |
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| Years | Employer | Title | Department |
| Years: 2004 to 2008 | Employer: Otsuka (Taiho Pharma) | Title: Director, Medical Affairs and Drug Safety | Department: Medical Affairs |
Responsibilities:Head of medical affairs and drug safety departments. Plan, design and conduct of clinical trials. Drug development strategic planning, drug evaluation of in/out licening, manage CROs and external experts, responsible for publication, drug labeling, training materials. In charge of safety pharmacovigilance. Attend FDA meetings |
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| Years | Employer | Title | Department |
| Years: 2000 to 2004 | Employer: Merck (Schering-Plough) | Title: Clinical Scientist and Project Leader | Department: Clinical Development |
Responsibilities:In charge of drug development team. design protocol, analysis results and IND/NDA filing. Clinical team leader for timelines, budgets and present to higher management. |
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| Years | Employer | Title | Department |
| Years: 1997 to 2002 | Employer: Tample University Hospital | Title: Fellow | Department: Cardiology |
Responsibilities:Cardiovascular research in heart transplantation patients |
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| Years | Employer | Title | Department |
| Years: 1993 to 1998 | Employer: Temple U. Sch. of Med | Title: Research Assistant | Department: Physiology |
Responsibilities:Research in gene therapy, immunology and molecular cardiology |
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| Years | Employer | Title | Department |
| Years: 1998 to 2000 | Employer: Covance | Title: Medical Associate | Department: Clinical Services |
Responsibilities:Medical monitor for clinical studies. keep client relationship. Study manager for clinical study team. |
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| Years | Employer | Title | Department |
| Years: 1990 to 1993 | Employer: Tianjin First Central Hospital | Title: Attending and Instructor | Department: Surgery |
Responsibilities:General surgery, surgical oncology. Urology, cardiac surgery experience |
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| Years | Employer | Title | Department |
| Years: 2012 to Present | Employer: Undisclosed | Title: Sr. Medical Director | Department: Clinical Development |
Responsibilities:Oncology: NSCLC, Breast Cancer, Colorectal Cancer, Prostate Cancer, Gastric Cancer, Hepatocellular Carcinoma, Renal Cell Carcinoma, Leukemia |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: to Present | Country / Region: China | Summary: He worked as a surgeon in teaching hospitals in China |
Career Accomplishments
| Associations / Societies |
|---|
| American Society of Clinical Oncology |
| Licenses / Certifications |
|---|
| medical license |
| Awards / Recognition |
|---|
| fellowship and scholarship awards |
| Medical / Professional |
|---|
| general surgery and surgical oncology |
| Publications and Patents Summary |
|---|
| 8 publications in peer review journals |
Additional Experience
| Training / Seminars |
|---|
| Oversee the publication strategy. Review training materials for national sales meeting and communication to regulatory authorities and media. Organize expert meeting, CME symposiums, and advisory broad meetings. |
| Vendor Selection |
|---|
| select CRO for central lab, clinical monitor, medical writing, pharmacovigilance, select clinical investigators and experts committee, safety monitoring board |
| Marketing Experience |
|---|
| Expertise in new drug development and product commercialization in oncology. Leading experience in new drug development stratagy, drug safety evaluation, clinical study conduct, CRO management, FDA regulations, IND-NDA filings, scientific publications. Follow up the trends in development and commercialization for global and US marketplace for oncology products. FDA pre-NDA meeting, end-Phase I-II meetings. hands-on experience in drug development plan, medical safety evaluation of compound for in-licensing, drug safety evaluation, protocol, data, report review and approval, patient enrollment, advertising, project budgeting |
Language Skills
| Language | Proficiency |
|---|---|
| Chinese |
Fields of Expertise
drug, prescription drug, drug clinical trial, drug development, new drug, drug product approval, drug labeling requirement, drug regulation, Food and Drug Administration regulation, investigational drug, investigational drug procedures, new drug application, drug safety testing, bioethics, prodrug, pharmacovigilance, craniotomy, prescription, gynecologic oncology, medical writing, oncologic surgery, drug evaluation, patient risk management, abbreviated new drug application, bioethics, pharmacodynamics, drug allergy, Food and Drug Administration compliance, alopecia, FDA food labeling regulation, pharmacoeconomics, medical device clinical research, drug toxicology, medical device premarket approval, governmental registration process, Food and Drug Administration drug registration, urogenital surgery, gynecologic drug development, pharmaceutical industry, Food and Drug Administration, reproductive system disease, drug, pharmacology, gynecology