Changkun Hu M. D.

About Changkun Hu M. D.

Over the past decades of my educations and careers, acted as a medical student, physician, graduate student, scientist, consultant, CRA, medical director, chief medical officer, project director, I, however, always focused on one thing-Committed to fighting diseases and improving human health and life. I dedicated the last 7 years to clinical research since I moved back to USA. Through training and practice as a CRA, I then worked for drug development either in a CRO company or pharmaceutical companies. What concerns me the most are malignancies including solid tumors and hematologic cancers, the other therapeutic areas that I have covered were cardiac disorders, eye disorders, nervous system disorders, respiratory disorders and infections.• 30+ years oncology, 10 years medical physician, 10+ years clinical research, 10+ years drug development, 7 years pharmaceutical industry• Highly self-motivated, results-driven, detail-oriented and objective focused with strong analytical and problem-solving skills;• Ability to handle multiple projects concurrently and independently;• Broad experience in pre-clinical research, clinical research, drug development, medical affairs, clinical practice, medical research and post market surveillance;• Good communication and interpersonal skills;• Proficient in Microsoft Office (Word, Excel, PPT), Mendeley, MedDRA, Adobe Photoshop, SPSS, GraphPad Prism, etc.

Experience

1. Clinical Scientist

   远大医药集团有限公司

   Feb 2020 — Present · Wuhan, CN

   Worked with cross-functional team to develop study protocols including bioequivalence (BE) studies for generic drugs and Phase 1-3 trials for innovative products; • Wrote clinical overview, clinical summary, IB, informed consent forms and drug labels, etc; • Participated in document retrievals, due diligence evaluation for products in various diseases (including tumors, neurological diseases, ophthalmic diseases, sepsis, cardiovascular diseases, etc.); • Searched, translated, proofread and reviewed documentations such as reports, published journal papers, patents, etc;• Provided medical oversight for clinical studies as a medical monitor for multiple trials.

Education

• Wuhan University

  Doctor of Medicine (MD), Medicine

  1980 — 1985

• Fudan University

  Master's degree, Radiation Oncology

  1988 — 1991

Skills

• Pharmaceutical Industry
• Dna Sequencing
• Life Sciences
• Word Processing
• Page Layout
• Clinical Trials
• Elisa
• Statistics
• Medical Research
• Print Production
• Spss
• Customer Service
• Laboratory Skills
• Qualitative Research
• Process Improvement
• Polymerase Chain Reaction (Pcr)
• Microsoft Office
• Clinical Research
• Public Speaking
• Good Clinical Practice (Gcp)
• Research
• Typography
• Biotechnology
• Presentations
• Strategic Planning
• Healthcare
• Medicine
• Management
• Molecular Biology
• Microsoft Excel
• Powerpoint
• Graphpad Prism
• Flow Cytometry
• Training
• Radiation Oncology
• Microsoft Word
• Spreadsheets
• Teaching
• Social Media
• Cell Culture