Experience

Pacira BioSciences, Inc.

• United States
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Senior Director - Clinical Lead Medical Strategy

  • Dec 2022 - Present

  Supervises the team and leads clinical development projects on use of stellate ganglion block with EXPAREL or Iovera for prevention of life-threatening arrhythmias. • Leads preparation of Clinical Development Plans, clinical trial protocols, and investigator brochures. • Constantly interacts with safety, regulatory and operations teams, and Contract Research Organizations (CROs). • Constantly interacts with key opinion leaders (KOLs) in the USA and Europe, organizes Steering Committees and Data Monitoring Committees (DMCs). • Leads preparation of Investigational New Drug Application (IND) and organization of meetings with Food and Drug Administration (FDA). • Leads preparation to the initiation of global phase III trial on use of stellate ganglion block with EXPAREL for prevention of post-operative atrial fibrillation in patients undergoing coronary artery bypass grafting. Show less



HengRui USA

• Senior Director – Clinical Lead Innovative Medicines

  • Jan 2021 - Nov 2022

  Led clinical development projects on use of hetrombopag in patients with severe aplastic anemia, chemotherapy-induced thrombocytopenia and use of FXIa inhibitor for prophylaxis of thrombosis. • Led preparation of Clinical Development Plans, clinical trial protocols, and investigator brochures. • Constantly interacted with safety, regulatory and operations teams in the USA, China, and Europe. • Constantly interacted with key opinion leaders (KOLs) in the USA and Europe, organized Advisory Boards. • Led preparation of Investigational New Drug Application (IND) submissions, and organization of meetings with Food and Drug Administration (FDA). • Led preparation to the initiation of global phase III trial on use of hetrombopag in patients with CIT. Show less



Sanofi Genzyme

• Clinical Research Director

  • Jul 2020 - Jan 2021

  Provided medical supervision of global phase 3 clinical trials on use of fitusiran in patients with hemophilia A and B. • Developed new clinical trials with fitusiran in patients with hemophilia A and B as well as new indications for the product. • Constantly interacted with medical affairs, safety, regulatory and operations teams as well as with KOLs. • Reviewed clinical trial and compassionate use protocols/amendments, investigator brochures, and clinical study reports. • Participated in Biologics License Application (BLA) submission and label preparation. Show less



Novo Nordisk

• Denmark
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Director/Director/Associate Director Clinical Development

  • Jun 2009 - Nov 2019

  Provided medical supervision of clinical trials for proposed new hemophilia medicines in North America: - Phase I-IV on use of recombinant factor VIII and IX products (including PEGylated) in patients with hemophilia A and B (12 trials in total). Products (Novoeight, Esperoct, and Rebinyn) received regulatory approval. - Phase I-III on use of concizumab (monoclonal antibody) in patients with hemophilia A and B (phase 3 program ongoing) [6 trials in total]. - Phase I-IV on use of recombinant factor XIII in patients with congenital FXIII deficiency (6 trials in total). Product (Tretten/NovoThirteen) received regulatory approval. • Initiated constant interaction on clinical development to trial sites (up to 25 sites per trial) and key opinion leaders (KOLs) in North America, and provided guidance to project management, medical affairs, medical liaison, safety, and regulatory teams in North America, and coordinated trial implementation with Copenhagen headquarters. • Reviewed trial protocols including investigator-initiated study protocols, Clinical Development plans, information letters, and prepared General Investigational Plans. • Prepared and participated in meetings with Food and Drug Administration (FDA), and participated in Biologics License Application (BLA) submissions and label preparations. • Presented at international congresses and symposia. Represented Company at national and international meetings. • Wrote manuscripts and abstracts. Show less



Mount Sinai Medical School

• United States
• Medical Practices
• 1 - 100 Employee

• Consultant

  • Apr 2008 - Mar 2009

  Designed and coordinated clinical trial devoted to use of normobaric oxygenation in patients with stroke. • Developed protocols, informed consent forms, and case report forms. • Facilitated communication between research centers, project teams, and sponsors. Designed and coordinated clinical trial devoted to use of normobaric oxygenation in patients with stroke. • Developed protocols, informed consent forms, and case report forms. • Facilitated communication between research centers, project teams, and sponsors.

• Study Director/Senior Staff Scientist/Staff Scientist

  • Dec 2005 - Sep 2008

  Designed and supervised 6 successfully completed research projects with budget of $75k-90k, revealing unique therapeutic effect of tested compound or unknown phenomenon / pathway: - Role of coagulation factor XIII in prevention of multiple organ dysfunction after gut ischemia-reperfusion injury, trauma-hemorrhagic shock, and burns (3 separate projects); - Coagulation disorders as cause of postoperative complications after pediatric cardiac surgery with special emphasis on role of coagulation factor XIII; - Role of C5a pathway in gut ischemia-reperfusion injury; - Impact of SDF-1 on platelet function in hemophilia. • Managed multi-institutional team of at least 5 scientists and technicians. • Organized collaboration and managed agreements between Novo Nordisk US and University of Medicine and Dentistry of New Jersey, and Bakoulev Center for Cardiovascular Surgery, Moscow, Russia for joint projects. • As subject matter expert (SME), participated in Novo Nordisk International Platelet Scouting Team. Show less



UMDNJ

• United States
• Hospitals and Health Care

• Clinical Research Coordinator/Research Associate

  • 2000 - 2008

  As a Clinical Research Coordinator (2005), designed and coordinated clinical trials in stroke and cardiology. • Enrolled patients, monitored various cardiac and neurological tests, and managed data. • Organized meetings with physicians and sponsor companies. • Communicated with Institutional Review Board (IRB). As a Research Associate (2000-2005), designed / implemented experimental and clinical research, receiving grant support from National Institutes of Health (NIH): - Erythrocyte disfunction in trauma-hemorrhagic shock, burns, pancreatitis, and coronary disease; - Gender differences in erythrocyte response to trauma / hemorrhagic shock and burns; - Effect of trauma-hemorrhagic shock on structure of erythrocyte membrane; - Effect of different resuscitation strategies on erythrocyte properties; - Effect of blood storage on erythrocyte properties (deformability and shape). • Prepared experimental and clinical study reports, performed statistical analysis, and interpreted data. • Wrote grants manuscripts and abstracts and made presentations at national and international congresses. Show less