Jingke Yang
Cary,NC
Summary
Physician-scientist (MD/PhD) with 8 years in sponsor-facing medical leadership and 7+ years of prior hematology-oncology practice. Leading Phase I-III medical monitoring and safety oversight across hematologic malignancies and solid tumors, partnering closely with sponsor clinical development teams and internal CRO cross-functional colleagues. Deep expertise in cell and gene therapy development, including CAR-T clinical trial oversight.
Overview
18
18
years of professional experience
Work History
Senior Medical Director
Parexel International
10.2021 - Current
- Lead medical monitoring and safety oversight for 20+ Phase I-III oncology trials across hematologic malignancies and solid tumors, including 5 pivotal studies supporting 3 approved products/indications (US/China) and 2 ongoing regulatory submissions.
- Serve as primary medical contact for sites and investigators, providing timely guidance on eligibility, AE/SAE/AESI assessment, dose modifications, concomitant medications, and escalation decisions.
- Chair investigator meetings; prepare and present medical/scientific content at Safety Review Committee meetings; assess and manage emerging safety signals.
- Review and interpret safety and efficacy data; identify clinically meaningful trends/risks; deliver actionable medical recommendations and support query resolution and data quality decisions.
- Partner with Pharmacovigilance, Clinical Operations, Data Management, and Biostatistics to ensure high-quality safety case processing, consistent medical documentation, and timely issue follow-up.
- Develop and/or review Medical Monitoring Plans, Medical Data Review Plans, and periodic medical/safety monitoring reports, ensuring alignment with protocol, ICH-GCP, and sponsor requirements.
- Provide medical input to core study documents (protocol, ICF, CRF) and contribute to risk assessments, issue management, and ongoing data surveillance.
- Serve as therapeutic area lead for cancer cell & gene therapy, providing medical training and mentorship for sponsors, sites, and internal teams; Lead author of an enterprise-wide CAR-T Safety Management SOP.
- Contribute medical/scientific expertise to proposals and bid defenses for oncology/CGT programs, as needed.
Medical Director
Parexel International
08.2019 - 10.2021
Associate Medical Director
Parexel International
02.2019 - 08.2019
Associate Chief Physician, Hematology (Board Certified)
The Affiliated Cancer Hospital of Zhengzhou University
01.2015 - 12.2017
- Managed inpatient and outpatient care for hematologic malignancies; developed individualized treatment plans and performed hematopoietic stem cell transplantation procedures.
- Investigator on multiple clinical trials in hematologic malignancies (including CAR-T-era and targeted therapies); contributed to peer-reviewed publications and grant/patent activities.
Research Fellow
Wellman Center for Photomedicine / Massachusetts General Hospital / Harvard Medical School
08.2013 - 01.2015
- Discovered that photobiomodulation therapy ameliorates immune thrombocytopenia and promotes engraftment of human umbilical cord blood-derived hematopoietic stem cells.
Hematology-Oncology Fellowship
The Affiliated Cancer Hospital of Zhengzhou University
07.2010 - 07.2013
Resident Physician, Internal Medicine
The Second Xiangya Hospital of Central South University
09.2007 - 03.2009
Education
PhD - Internal Medicine (Hematology)
Xiangya Medical School, Central South University
China01.2010
MS - Pharmacology
Henan Medical School, Zhengzhou University
China01.2007
MD - Medicine
Henan Medical School, Zhengzhou University
China01.2004
Skills
- Therapeutic Area: Hematology, Oncology
- Years: 78, 77
- Indications: AML, MDS, ALL, B-Cell Lymphoma, DLBCL, Follicular Lymphoma, MZL, Hodgkin Lymphoma, T-Cell Lymphoma, Extranodal NK/T-Cell Lymphoma, Waldenström Macroglobulinemia, Myelofibrosis, ITP, Hemophilia A, Breast Cancer, NSCLC, Prostate Cancer, Urothelial Cancer, CNS Tumors, Head & Neck Cancer, Gastric/Esophageal Cancer, Advanced Solid Tumors
- Modalities: CAR T-cells, TCR T-cells, molecular targeted agents, immune checkpoint inhibitors, monoclonal antibodies, antibody-drug conjugates, recombinant coagulation factors, PSMA PET radiotracer
Affiliations
- Member, American Society of Hematology (ASH), 2019 – Present
- Science Editor, Cancer Translation Medicine, 2014 – 2019
LANGUAGES
English: Fluent (Professional Working Proficiency)
Chinese: Fluent (Native)
SELECTED PUBLICATIONS
- 30+ peer-reviewed publications. Selected:
- Zeng Z, Yang A, Yang J, et al. Sintilimab (anti-PD-1 antibody) combined with high-dose methotrexate, temozolomide, and rituximab (anti-CD20 antibody) in primary central nervous system lymphoma: a phase 2 study. Signal Transduct Target Ther. 2024.
- Wang X, Wei L, Yang J, et al. DNA methylation determines the regulation of pregnane X receptor on CYP3A4 expression. Clin Exp Pharmacol Physiol. 2021.
- Zhang Q, Steensma D, Yang J, et al. Uncoupling of CD71 shedding with mitochondrial clearance in reticulocytes in a subset of myelodysplastic syndromes. Leukemia. 2019.
- Yang J, Zhang Q, et al. Low-level light treatment ameliorates immune thrombocytopenia. Sci Rep. 2016.
- Xiao X#, Yang J#, et al. Deregulation of mitochondrial ATPsyn-β in AML cells with increased drug resistance. PLoS One. 2013. (#Co-first author)
- Complete publication list available upon request
Timeline
Senior Medical Director
Parexel International
10.2021 - Current
Medical Director
Parexel International
08.2019 - 10.2021
Associate Medical Director
Parexel International
02.2019 - 08.2019
Associate Chief Physician, Hematology (Board Certified)
The Affiliated Cancer Hospital of Zhengzhou University
01.2015 - 12.2017
Research Fellow
Wellman Center for Photomedicine / Massachusetts General Hospital / Harvard Medical School
08.2013 - 01.2015
Hematology-Oncology Fellowship
The Affiliated Cancer Hospital of Zhengzhou University
07.2010 - 07.2013
Resident Physician, Internal Medicine
The Second Xiangya Hospital of Central South University
09.2007 - 03.2009
MS - Pharmacology
Henan Medical School, Zhengzhou University
MD - Medicine
Henan Medical School, Zhengzhou University
PhD - Internal Medicine (Hematology)
Xiangya Medical School, Central South University