Elena Maksimova, PhD

Associate Director, Clinical Sciences at Regeneron Pharma at Regeneron Pharmaceuticals, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
New York City Metropolitan Area
Languages
  • English -
  • Russian -

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Experience

    • United States
    • Biotechnology
    • 700 & Above Employee
    • Associate Director, Clinical Sciences at Regeneron Pharma
      • Jun 2018 - Present

      Lead clinical development of the phase I/II/III protocols and study activities for several indications (Oncology/Hematology - r/r multiple myeloma, smoldering myeloma, MGUS_BCMAxCD3; COVID-19, Pain due to osteoarthritis) Lead clinical development of the phase I/II/III protocols and study activities for several indications (Oncology/Hematology - r/r multiple myeloma, smoldering myeloma, MGUS_BCMAxCD3; COVID-19, Pain due to osteoarthritis)

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Clinical Scientist/Assoc Director
      • Jun 2016 - Jun 2018

      Oncology/ Immuno-oncology (i-o): Phase II, III -Keytruda (pembrolizumab, PD-1 inhibitor), solid tumors/ adults Oncology/ Immuno-oncology (i-o): Phase II, III -Keytruda (pembrolizumab, PD-1 inhibitor), solid tumors/ adults

    • Switzerland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Clinical Manager
      • Mar 2013 - Jun 2016

      • Global Oncology Clinical Development, Phase I-III --March 2013 - March 2015: TKI Team: solid tumors, adults --March 2015 - June 2016: Gene&Cell Therapies Unit - (CART) Chimeric Antigen Receptor Adoptive T- cell therapy (immunotherapy) CTL019 Team: hematological malignancies - r/r acute leukemia (ALL), pediatric • Global Oncology Clinical Development, Phase I-III --March 2013 - March 2015: TKI Team: solid tumors, adults --March 2015 - June 2016: Gene&Cell Therapies Unit - (CART) Chimeric Antigen Receptor Adoptive T- cell therapy (immunotherapy) CTL019 Team: hematological malignancies - r/r acute leukemia (ALL), pediatric

    • Pharmaceutical Manufacturing
    • 500 - 600 Employee
    • Clinical Scientist
      • Feb 2011 - Jan 2013

      • Clinical development and study management to provide scientific and logistical support to planned and ongoing CNS trials, Phase II, III; Regulatory submission for Cariprazine (schizophrenia) • Clinical development and study management to provide scientific and logistical support to planned and ongoing CNS trials, Phase II, III; Regulatory submission for Cariprazine (schizophrenia)

    • Quality Control (Document) Specialist
      • May 2010 - Jan 2011

      • Quality control and assurance; reviewing regulatory documentation (Trial Master File documents) related to the conduct of clinical trials for compliance with internal standards and GCP/ICH guidelines • Quality control and assurance; reviewing regulatory documentation (Trial Master File documents) related to the conduct of clinical trials for compliance with internal standards and GCP/ICH guidelines

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Clinical Research Associate (CRA) /Monitor
      • Sep 2009 - Sep 2010

      • Monitoring the study of investigational medical device for early detection of breast cancer in accordance with the Protocol and SOPs to insure the integrity per Protocol and GCP guidelines • Monitoring the study of investigational medical device for early detection of breast cancer in accordance with the Protocol and SOPs to insure the integrity per Protocol and GCP guidelines

    • Consultant/Analyst
      • 2008 - Mar 2010

      • Designed, managed and analyzed primary, as well as secondary research data to support business objectives and decision-making processes • Provided recommendations based on business implications of findings • Designed, managed and analyzed primary, as well as secondary research data to support business objectives and decision-making processes • Provided recommendations based on business implications of findings

    • United States
    • Higher Education
    • 400 - 500 Employee
    • Research Scientist
      • Aug 2004 - 2008

      • Planned, managed and implemented research project’s activities to explore an anticancer mechanism of cholesterol-lowering drug Lovastatin (Mevacor) in non-small cell lung cancer • Assessed, analyzed and proactively developed experiments to elucidate the role of microRNAs in non-smal and small cell lung cancers • Planned, managed and implemented research project’s activities to explore an anticancer mechanism of cholesterol-lowering drug Lovastatin (Mevacor) in non-small cell lung cancer • Assessed, analyzed and proactively developed experiments to elucidate the role of microRNAs in non-smal and small cell lung cancers

    • Research Scientist
      • Mar 2001 - Feb 2003

      • Conducted experiments to examine the regulation of Bruton's tyrosine kinase (Btk), the protein which genetic defects cause the human disease X-linked agammaglobulinemia (XLA) • Conducted experiments to examine the regulation of Bruton's tyrosine kinase (Btk), the protein which genetic defects cause the human disease X-linked agammaglobulinemia (XLA)

    • Research Scientist (post-doc)
      • Jan 1998 - Feb 2001

      • Carried out a project to identify the formation of a new complex between the wild-type human insulin receptor beta-subunit and molecule X, a thiol-reactive membrane-associated protein • Carried out a project to identify the formation of a new complex between the wild-type human insulin receptor beta-subunit and molecule X, a thiol-reactive membrane-associated protein

Education

  • Harvard University
    Women in Leadership: Program for Emerging Leaders
    2022 -
  • Temple University
    MS, Quality Assurance/ Regulatory Affairs
  • New York University
    Certificate, Business Project Management (PMP)
  • Rutgers University
    mini-MBA, BioPharma Innovation Program
  • Russian Academy of Medical Sciences, Moscow
    PhD, Biochemistry

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