Elena Maksimova, PhD
Associate Director, Clinical Sciences at Regeneron Pharma at Regeneron Pharmaceuticals, Inc.- Claim this Profile
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Bio
Experience
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Regeneron
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United States
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Biotechnology
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700 & Above Employee
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Associate Director, Clinical Sciences at Regeneron Pharma
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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)
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Merck
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Clinical Scientist/Assoc Director
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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
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Novartis
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Clinical Manager
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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
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Forest Laboratories (now Allergan)
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Pharmaceutical Manufacturing
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500 - 600 Employee
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Clinical Scientist
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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)
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Quality Control (Document) Specialist
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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
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GE HealthCare
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United States
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Associate (CRA) /Monitor
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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
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Consultant/Analyst
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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
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CUNY School of Medicine
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United States
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Higher Education
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400 - 500 Employee
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Research Scientist
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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
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Cornell University Weill Medical College
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New York, NY
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Research Scientist
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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)
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Research Scientist (post-doc)
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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
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Education
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Harvard University
Women in Leadership: Program for Emerging Leaders -
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