Jerry J. Li Email and Phone Number
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Close to 14 years of pharmaceutical and regulatory experiences in multiple therapeutic areas: oncology/ hematology, infectious diseases, immunology and neurosciences. • Experienced in phases 2 and 3 registration studies, and phases 1 and 2 dose finding and dose optimization. • Protocol design and development, IND, NDA, BLA submissions to the worldwide health authorities including FDA, EMA, PMDA, CDE. • Interacting with regulatory agencies worldwide; responding to information requests and comments, and meetings with the agencies• Recruiting and managing statisticians • Statistical representative working with cross-function teams including clinical, regulatory, commercial, operation, medical affairs.• Experienced in working with CROs
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Ta Lead, Global Biometrics And Data Sciences (Gbds)Bristol Myers SquibbNew York, Ny, Us -
Ta Lead Of Hematology Malignant Myeloid Diseases - Global Biometrics And Data Sciences (Gbds)Bristol Myers Squibb Nov 2021 - PresentLawrence Township, Nj, Us• Leading multiple assets in malignant hematology myeloid diseases including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and myelofibrosis (MF). • Program lead for the protocol development, corporate governance committees and regulatory interactions including FDA, EMA, PMDA, CDE on NDA/BLA submissions as well as IND submissions on phase 2/3 operational seamless design and phase 1/2 dose finding/dose optimization. • Standing Committee Member of BMS Hematology Protocol Review Committee (PRC) reviewing and approving all hematology studies (myeloid diseases, lymphoma, multiple myeloma as well as non-malignant hematological diseases) design, protocol amendment, statistical analysis plan, etc. • Established and co-lead of the department wide Dynamic Borrowing Working Group across all TAs as well as early phase group, medical affairs group and data sciences group.• Liaison of GBDS and Pediatric Center of Excellence (PCoE)• Conducted due diligence and business development to successfully acquiring external ADC asset.• Build and manage a group of talented statisticians. -
DirectorDaiichi Sankyo Us Apr 2021 - Nov 2021Basking Ridge, Nj, UsOncology ADC Drug Development -
Principal Scientist, Associate Principal Scientist, Senior Scientist - (Bards)Merck 2013 - 2021Oncology Studies• Phase 3 study, Keytruda (pembrolizumab) plus chemo and targeted therapy for first line cervical cancer • Phase 3 study, Keytruda in combination with Lenvima (lenvatinib) treating first line hepatocellular carcinoma (HCC). • Phase 2 and 3 studies, relapsed or refractory (R/R) classical Hodgkin’s Lymphoma (cHL) (the first hematological indication approval for Keytruda)• Phase 1b, multi-cohort, Keytruda+folfox/folfori+targeted therapy treating metastatic colorectal cancers (1L, 2L and 3L).• Integrated summary of safety (ISS) for multiple Keytruda phase 3 studies across various indications Non-oncology Studies: Infectious Disease: Phase 2 and 3 studies of Zepatier treating chronic hepatitis C. Immunology: Phase 3 study of Simponi treating non-radiographic axial spondyloarthritis (nr aSpA),Neurosciences:• Phase 3 study of verubecestat, a BACE Inhibitor, treating participants with Alzheimer’s Disease • Phase 2a/b study of double-blind, placebo-controlled study of an allosteric modulator of the M1 muscarinic receptor treating mild to moderate Alzheimer’s Disease• Phase 4 PMR study of Bridion (sugammadex) for the reversal of neuromuscular blockade induced by either rocuronium bromide or vecuronium bromide. Closely involved in designing and developing the following studies:• Phase 3 Study of randomized, open- label placebo-controlled trial of pembrolizumab (Keytruda) in combination with lag3 for 1L, 2L and 3L+ metastatic colorectal cancer• Phase 2 tissue/site agnostic study of Keytruda in subjects with advanced solid tumors containing high tumor mutation burden (hTMB). • Phase 3 study of a triplet treatment regimen (uprifosbuvir/grazoprevir/ruzasvir) in subjects with chronic HCV GT1-6 genotypesStatistical Methodology and Research: • Statistical modeling of disease-modifying treatment effect in Alzheimer's Disease • Properties of log-rank test following covariate-adaptive randomization in oncology trials
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Mathematical StatisticianFda 2011 - 2013Silver Spring, Md, Us• Worked closely with biostatistics colleagues and medical officers reviewing IND and NDA submissions• Actively involved in research on statistical methods to further improve drug review and approval process including missing data and standardizations of the dataset structure
Jerry J. Li Skills
Jerry J. Li Education Details
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University Of MarylandStatistics -
Columbia UniversityBiomedical Sciences
Frequently Asked Questions about Jerry J. Li
What company does Jerry J. Li work for?
Jerry J. Li works for Bristol Myers Squibb
What is Jerry J. Li's role at the current company?
Jerry J. Li's current role is TA Lead, Global Biometrics and Data Sciences (GBDS).
What is Jerry J. Li's email address?
Jerry J. Li's email address is jl****@****ail.com
What is Jerry J. Li's direct phone number?
Jerry J. Li's direct phone number is +120179*****
What schools did Jerry J. Li attend?
Jerry J. Li attended University Of Maryland, Columbia University.
What skills is Jerry J. Li known for?
Jerry J. Li has skills like R, Clinical Trials, Sas, Statistical Programming, Sas Programming, Survival Analysis, Data Analysis, Molecular Biology, Drug Development, Genomics, Statistical Modeling, Epidemiology.
Who are Jerry J. Li's colleagues?
Jerry J. Li's colleagues are Antonia Lopez-Girona, Sharon Mccrary, Tyrone Walterson Walterson, Rodrigo Blanc, Manisha Mone, Santiago Beltran Vaquerizo, Graham Springs.
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