Yang Liu
Medical Director Clinical Development @ Verastem Oncology
About
I am a clinical development professional (oncology) committed to bringing new drugs from laboratories to patients. My expertise spans early and late clinical development (solid tumors and hematological malignancies), translational research and disease strategic planning.
United States
Greater Boston
Pharmaceuticals
Early-Late Clinical Development , Safety Review, Coding Review, Medical Review, Medical Monitoring, Scientific Leadership , Disease strategic planning, Cross-Functional Collaboration, Medical Monitoring, sNDA, scientific leadership, cross-functional collaboration, protocol development, disease/therapeutic area specific strategies., Communication, Cancer, Angiogenesis, Grant Writing, Finance, Quantitative Analytics, Analysis, Statistics, Data Analysis, SPSS, Research
Experience

Medical Director Clinical Development
Boston, MA
· Serves as the lead medical director for the RAMP-301 Study (a registrational global phase 3 study in recurrent Low-Grade Serous Ovarian Cancer) to ensure compliance and patient safety. · Serves as the primary contact for medical-related inquiries from investigators, and internal/external teams, ensuring consistent protocol interpretation and clarification, including eligibility review, AE managements, dose modifications, etc. · Acts as a key member of the RAMP-301 Study team to devise integrated development plan(s) and development / regulatory strategies. · Works with safety to provide ongoing and ad hoc safety data analyses for the study IDMC, internal safety committee and regulatory requests as required.

Senior Director, Global Lead, Clinical Science
Boston, MA
· Function as medical monitor for the RAMP301 study (a registrational global phase 3 study in recurrent Low-Grade Serous Ovarian Cancer). · Responsible for the clinical/scientific development/authorship and execution of the RAMP301 study in close partnership with the other key members of the development team. · Contribute to development/authorship of key strategic and clinical documents, e.g., protocol amendment, responses to Health Authorities questions. · Communicate/coordinate with investigators and review and query, as needed, clinical trial data, in close partnership with the medical, safety, clinical pharmacology and data sciences function, to ensure quality and integrity of study data and appropriate medical/safety oversight.

Senior Director Clinical Development Scientist
Boston, MA
Mirati was acquired by BMS in Jan 2024. Clinical Development – Oncology (NSCLC and other solid tumors, e.g., CRC, urothelial carcinoma, renal cell carcinoma). • Worked with cross-functional teams to successfully achieve database lock for final analysis for two global phase 3 studies: 1) SAPPHIRE (Sitravatinib in combination with Nivolumab versus Docetaxel), and 2) KRYSTAL-12 (Adagrasib versus Docetaxel) in patients with previously treated NSCLC. • Acting Medical Monitor for a phase 2 study. • Contributed to Adagrasib sNDA for full approval. • Contributed to clinical trial protocol development and other study documents review, e.g., ICF, CSR, IB, eCRF, CCGs, TFLs.

Global Development Scientist
Greater Boston
Clinical Development - Hematological malignancies including lymphoma and leukemia (phases I, II and III) • Performed medical review of patient profiles, data listings/TFLs, and patient monitoring • Contributed to clinical trial protocol development (writing, review and amendment) and execution • Supported development of clinical study documents, e.g., Development Safety Update Report, Period Benefit-Risk Evaluation Report, Independent Data Monitoring Committee Charter, Informed Consent Forms.

Senior Clinical Research Scientist
Great Boston Area, Massachusetts, United States
Clinical Development - Solid tumors including glioblastoma and melanoma (phases I and II) • Contributed to the clinical trial protocol development and execution • Monitored patient data in EDC • Supported clinical study documents and regulatory submission, e.g., Development Safety Update Report, Clinical Study Report, Investigator Brochure, Data Safety Monitoring Board, orphan drug application, informed consent forms, medical monitoring plan • Supported clinical development/disease strategy planning including data analysis and literature review

Instructor and Research Assistant Professor
Rochester, New York Area
Conducted clinical research and investigated novel therapeutic targets for brain cancer including primary brain cancer and brain metastasis from other cancers. • Collaborated with a pharmaceutical company to design/implement preclinical study of drug targeting brain cancer. • Identified barriers to clinical trial participation (phase 1-3), characterized strategy to maximize clinical trial outcomes. • Collaborated with industry and academia to carry out clinical research (phase 4) for brain cancer. • Supervised/trained lab technicians and students.

Postdoctoral Associate
Greater Pittsburgh Area
Managed study and played a critical role in investigating and identifying biomarkers for early detection of lung cancer. Demonstrated that multiple genes were methylated in lung tumor, and furthermore, that specific gene methylation can be detected in sputum from high-risk population, suggesting potential clinical implications for diagnosis of lung cancer.
Yang Liu's Contact Information
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