Abinav Kumar Singh, PhD

Experience

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  University of Southern California

  Jan 2009 - Aug 2011

  Postdoctoral Fellow/ Research Associate - Inflammation Research

  Respiratory Inflammation research: Characterized the role of Programmed cell death markers co-stimulation on NKT cells in respiratory diseases including Asthma inflammatory responses and influenza virus pathogenesis.

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  Stanford University Medical Center

  Sept 2011 - Feb 2013

  Postdoctoral Fellow - Autoimmune diseases

  Narcolepsy/Autoimmune research: Characterized the T-cell response and role of auto-antibodies on hypocretin/Orexin function following immunization with GSK influenza vaccine Pandermix and other seasonal FLU vaccine in humanized mice models.

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  The University of Texas Medical Branch at Galveston

  Mar 2013 - Dec 2017

  Postdoctoral Fellow

  • Inflammatory Bowel Diseases: Studied the role of Co-stimulatory molecules, PD-L1 expressed on colonic fibroblast cells in IBDs and colon cancer. Manage Protocol development, IRB communications, data analysis, and project management.

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  Collaborative Clinical Research Solutions, Inc. (d/b/a CCRS Consultants)

  Sept 2017 - Feb 2019

  Clinical Research Analyst

  • Served as liaison between study sponsors and UT Health System investigators-physicians and KOLs.• Assessed initial interest in incoming industry-sponsored oncology trials by overall UT investigators pool for basic site capabilities, investigator qualifications, and access to patient population.• Performed regulatory submissions for oncology trials to both institutional IRBs and commercial (external) IRBs.• Provided coverage analysis for budget estimation for oncology trials.

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  BioMérieux

  Mar 2019 - Jul 2021

  Clinical Scientist

  • Worked in the bioMérieux Immunoassays Clinical Affairs group for the successful launch of TB Immunoassay (EU/FDA approved) and Acute Kidney Injury (AKI) assays (FDA approved).• Led global CRO/vendor management, development of study manuals, workflow procedures, and study documents.• Led identification and qualification of sites, and KOLs management (both US and OUS).• Performed SIVs and protocol training for vendors and clinical sites. Led sites' data monitoring and site closeout.

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  T2 Biosystems

  Jul 2021 - Jun 2022

  • Led product approval strategies and investigational plans for T2-Biothreat Panel (FDA approved) and T2-AMR diagnostics assays (FDA under submission), leveraging internal and external resources.• Held responsibility for clinical site feasibility, protocol training, monitoring, source document verification, and regulatory submissions.• Managed external vendors, core labs, budget, contracts, and safety reporting.• Developed study protocols and trial-related documents such as case report forms, informed consent documents, investigator recruitment materials, and established recruitment plan and strategies. Show less

  • Senior Manager Clinical Affairs

    Mar 2022 - Jun 2022

  • Manager Clinical Affairs

    Jul 2021 - Mar 2022
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  R&D Partners

  Oct 2022 - Jan 2023

  Contractor Study Lead

  Contract role: Provides medical/scientific input into pharma protocols for Post market studies.

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  Abbott

  Jan 2023 - Mar 2025

  • Led execution of global clinical evidence generation studies, ensuring compliance with ICH/GCP, relevant regulations, DEI plans and company standards for FDA, EU/UK, and PMDA approval.• Directed team of CRAs, leading clinical projects for Respiratory (COVID/FLU/RSV), and STI (CT/NG) assays.• Supported HEOR, Ethnography, and Observational studies for clinical evidence generation. • Prepared and managed project deliverables, project plan, resource allocation, budget, contract, and timelines.• Collaborated on studies utilizing Real-World Evidence (RWE) to generate evidence for HEOR and ethnography. Show less

  • Senior Manager, Clinical Strategy Lead, RMDx, Lateral Assays and Molecular Diagnostics

    Jul 2023 - Mar 2025

  • Senior Manager, Clinical Affairs, IDDM

    Jan 2023 - Jul 2023