Qingqin Li
Flemington,NJ
Summary
- 25+ years of pharmaceutical industry experience in the field of Translational Research/Biomarkers/ Pharmacogenomics/Clinical Trial/Computational Biology/Data Science/Digital Health/Real World Evidence (RWE)/Bioinformatics/Artificial Intelligence/Machine Learning/Applied Statistics
- 7 years of academic experience in Molecular Biology, Biochemistry, Cell Biology, and Molecular Genetics.
- Mission-focused, problem-orientated, versatile scientific leader championing Biomarker Discovery and Validation/Target Identification/Target Validation/Human Genetics/Precision Medicine/Stratified Medicine/Data Science from strategic vision to flawless implementation.
- Lead internal/external collaborations but can also be independent/hands-on (end-to-end from project proposal, funding approval, to data collection and analysis/reporting) where warranted
- Track record of maintaining comprehensive scientific strategy for clinical programs, trailblazing novel approaches, building up new capabilities, and delivering high-quality results with scientific/statistical rigors.
Overview
28
28
years of professional experience
1
1
Certificate
Work History
Senior Director
Janssen Research & Development, Johnson & Johnson
04.2022 - Current
- Serve as Data Science Lead to represent Data Science as a function (2021-) in selected Compound Development Teams (CDTs) responsible for precision medicine, digital health, and real-world evidence (RWE) strategy and implementation (one compound each in phase I, II, III, post-launch stage)
- Responsible for end-to-end scientific strategies for precision medicine, digital health, and RWE.
- Lead major depressive disorder (MDD) (2017-) and schizophrenia patient subtype identification and characterization (2021-)
Scientific Director
Janssen Research & Development, Johnson & Johnson
05.2019 - 04.2022
- Translational Research Role
- Multi-omics lead for biomarker discovery and validation (2013-) for company-sponsored observational clinical study to predict MDD relapse (NCT02489305) and 6 phase III esketamine studies (end-to-end, biomarker sections in Clinical protocols, budget approval for data generation, CRO qualification and management, data analysis and reporting, and result dissemination), consortium ADNI epigenetic study, and in collaboration with selected external academic group (e.g., McGill University)
- Multi-omics lead for target identification/target validation via research studies such as Alzheimer’s disease (AD, 2013-)/Parkinson’s Disease (PD, 2023-) post-mortem brain studies
- Pharmacogenomics/genetics/genomics lead (2002-) for internal antipsychotics, antidepressant, pain, neurology (epilepsy and AD) studies, Janssen Principle Investigator (PI) in Psychiatric Genomic Consortium (schizophrenia, bipolar disorder, Major depressive disorder, suicide, eating disorder (ED), and AD working groups), ILAE (epilepsy), and ADNI Genetics and Epigenetics Working Group, and in collaboration with selected external academic (e.g., University of Utah) and industry partners (e.g. 23andMe).
- Clinical trial | Digital health roles (2015-):
- Solution Development Team Leader (SDTL)/Clinical Lead (CL)/Study Responsible Scientist (SRS) for a company-sponsored observational clinical study to predict schizophrenia relapse (NCT03629951), multi-omics lead for company-sponsored observational clinical study to predict MDD relapse (NCT02489305), SRS for collaborative studies with CAN-BIND (NCT02934334), Veteran Affairs, and Ad Scientiam. Each study highlighted implements a digital health strategy including objective speech/voice analytics, actigraphy, and passive behavior sensing, which could generate insights for patient enrichment strategy and support the post-product launch (i.e. Disease management clinical decision tool)
- Address emerging clinical needs (such as ALT elevation) and predict treatment response (efficacy and side effect) (2002-)
- Real World Evidence Role:
- RWE predictive analytics (2017-): using RWE data to build predictive model to predict clinical events of interest such as suicidal attempts and suicide death (internal efforts and partnership with Optum Insight).
- Evidence generation to support clinical assets: unmet needs, patient journey, and comparative effectiveness using both survey (i.e. deploy custom survey to 23andMe members), RWD (EHR and claims), and historical clinical data (in conjunction with new investigative compound data)
Director, NS & CVM Business Technology Leader
Janssen Research & Development, Johnson & Johnson
10.2016 - 05.2019
- Identify opportunities to support NS and CVM’s business needs (Drug Discovery, Biomarkers, Clinical Development) by filling the gaps and enhancing efficiency, as well as provide analytics to key clinical programs to support product differentiation strategy.
- For neuroscience, my roles in Integrative Solutions continued but expanded as new opportunities arose. These responsibilities continued into the roles in Neuroscience Data Science (one team essentially under different “brands”).
- Use RWE data to build major bleeding models for anticoagulants as a product differentiation strategy.
Director, NS Integrative Solutions and Informatics
Janssen Research & Development, Johnson & Johnson
10.2013 - 10.2016
- Problem-centric, technology-agnostic scientific leader: current state of art landscape assessment, think big: What is needed to tackle a problem of interest to the business unit, leverage internal/external data/samples to address the problem, collaborate with internal/external partners on the opportunity on data collection/generation and conduct (clinical) study when there is a significant gap
- Hands-on in implementation when resources are short, but leverage Discovery Science collaborators where possible
Director, Analytics Group Leader, NS Biomarkers
Janssen Research & Development, Johnson & Johnson
06.2011 - 10.2013
- Responsible for neuroscience biomarker and pharmacogenomic data analysis
- Resource management
Director, Bioinformatics Group Leader
Janssen Research & Development, Johnson & Johnson
03.2006 - 06.2011
- Responsible for cross-TA Pharmacogenomic analysis (GWAS and large scale candidate gene studies).
- Build up internal capability in human genetics (2002-) and Next Generation Sequencing (NGS, 2008-)
- Build up NGS computing infrastructure and data analysis capabilities (2008-) including whole exome sequencing, whole genome sequencing, bulk RNA-Seq, mutational profiling, etc.
Bioinformaticist – Project Lead
Johnson & Johnson Pharmaceuticals R&D, LLC
03.2003 - 02.2006
Senior Bioinformaticist
Johnson & Johnson Pharmaceuticals R&D, LLC
07.2002 - 02.2003
Principal Research Scientist
Eli Lilly And Company
01.2002 - 06.2002
Senior Scientist, Bioinformatics, Research Technol
Eli Lilly And Company
06.1998 - 12.2001
- Microarray analytic capability Leader (cross-TA and functions) - a vertical role
- Provide bioinformatics support for Research Technology and Proteins(biologic) and Oncology TA - a horizontal role
Research Fellow
The University Of Chicago
10.1997 - 04.1998
Research Fellow
Mass General Hospital
04.1996 - 09.1997
- Received Leukemia Society of America Postdoctoral Fellowship Award following up the work of "αLβ2 integrin/LFA-1 binding to ICAM-1 induced by cytohesin-1, a cytoplasmic regulatory molecule" by W Kolanus, W Nagel, B Schiller, L Zeitlmann, S Godar, H Stockinger, B Seed published in Cell (2016),
- Molecular cloning of homologous cytohesin family members and identified and sequenced cytohesin-2 and cytohesin-3.
- Establish cell adhesion assay to measure the in vitro integrin binding activity
- Establish mouse knock-out (KO) lines for three genes in preparation for crossing to derive triple KO.
- Assisted another project in biochemical assays (Xavier R, Brennan T, Li Q, McCormack C, Seed B. Membrane compartmentation is required for efficient T cell activation. Immunity. 1998;8(6):723-732)
Research Fellow
Emory University
09.1995 - 03.1996
Education
Master of Science - Computer Science
The University of Chicago
Chicago, IL06.1998
Ph.D. - Biochemistry And Molecular Biology
Emory University
Atlanta, GA08.1995
Bachelor of Science - Biochemistry
Fudan University
Shanghai, PRC07.1991
Skills
- Scientific Strategy and implementation
- Resource management and project prioritization
- Genomics (genetics/epigenetics)/transcriptomics (bulk RNA-Seq, small RNA-Seq/circulating miRNA)/proteomics/biomarker discovery and validation/target discovery/target validation/digital health/RWE
- Statistical Genetics/Computational biology/Applied Statistics/Artificial Intelligence/Machine Learning/System Biology
- Programming skills including R, SAS, Perl, Python, Java, Oracle/MySQL/RedShift relational databases
- HPC Computing (Amazon AWS and on-premises HPC cluster)
Accomplishments
- Co-principal investigator on the Horizon 2020 Project REALMENT leveraging RWE and clinical trial data to enable precision psychiatry (2021-2025)
- Authored 80+ peer-reviewed articles (h-index 43)
o First author in journals such as Molecular psychiatry, Clin Epigenetics, Transl Psychiatry, Brain Behav Immun Health, Scientific reports, Front Psychiatry, Front Neurosci, BMC genomics, PLoS One, Pharmacogenet Genomics, Psychiatry Res, The Clinical journal of pain with impact factors up to 13.44 - 4 issued patents
- Contributed to high impact consortium findings (Psychiatric Genomic Consortium (PGC), Alzheimer's Disease Neuroimaging Initiative (ADNI), International League Against Epilepsy (ILAE) Consortium on Genetics of Complex Epilepsies, etc.
Certification
Certificate in Applied Statistics (2006)
Languages
English
Chinese (Mandarin)
Affiliations
- Society of Biological Psychiatry
- The International Society of Psychiatric Genetics
Timeline
Senior Director
Janssen Research & Development, Johnson & Johnson
04.2022 - Current
Scientific Director
Janssen Research & Development, Johnson & Johnson
05.2019 - 04.2022
Director, NS & CVM Business Technology Leader
Janssen Research & Development, Johnson & Johnson
10.2016 - 05.2019
Director, NS Integrative Solutions and Informatics
Janssen Research & Development, Johnson & Johnson
10.2013 - 10.2016
Director, Analytics Group Leader, NS Biomarkers
Janssen Research & Development, Johnson & Johnson
06.2011 - 10.2013
Director, Bioinformatics Group Leader
Janssen Research & Development, Johnson & Johnson
03.2006 - 06.2011
Bioinformaticist – Project Lead
Johnson & Johnson Pharmaceuticals R&D, LLC
03.2003 - 02.2006
Senior Bioinformaticist
Johnson & Johnson Pharmaceuticals R&D, LLC
07.2002 - 02.2003
Principal Research Scientist
Eli Lilly And Company
01.2002 - 06.2002
Senior Scientist, Bioinformatics, Research Technol
Eli Lilly And Company
06.1998 - 12.2001
Research Fellow
The University Of Chicago
10.1997 - 04.1998
Research Fellow
Mass General Hospital
04.1996 - 09.1997
Research Fellow
Emory University
09.1995 - 03.1996
Master of Science - Computer Science
The University of Chicago
Ph.D. - Biochemistry And Molecular Biology
Emory University
Bachelor of Science - Biochemistry
Fudan University
Similar Profiles
Mary ProctorMary Proctor
Associate Director- Regulatory Affairs, CMC at Janssen Research & Development, Johnson & JohnsonAssociate Director- Regulatory Affairs, CMC at Janssen Research & Development, Johnson & Johnson
GINA DURANGINA DURAN
Field Reimbursement Manager at Johnson & Johnson, Janssen PharmaceuticalsField Reimbursement Manager at Johnson & Johnson, Janssen Pharmaceuticals
Boryana AlexievaBoryana Alexieva
GOVERNMENT AFFAIRS PATIENT ENGAGEMENT LEAD at JANSSEN PHARMACEUTICA JOHNSON & JOHNSONGOVERNMENT AFFAIRS PATIENT ENGAGEMENT LEAD at JANSSEN PHARMACEUTICA JOHNSON & JOHNSON