SENIOR MEDICAL DIRECTOR FOR CLINICAL RESEARCH AND DEVELOPMENT
Leads cross-functional coordination of multiple clinical trials, ensuring medical integrity and regulatory compliance through development of scientific study plans, management of tactical aspects, and directing investigative protocols. Engages communications with external partners and internal / corporate professionals to establish medical findings, discoveries, and regulatory approvals.
HengRui USA, Princeton, NJ ,Senior Director Clinical Science Non-Oncology( present)
Leads clinical development projects on use of hetrombopag in patients with severe aplastic anemia,
chemotherapy-induced thrombocytopenia and use of FXIa inhibitor for multiple indications.
- Develops Clinical Development Plans, clinical trial protocols, and investigator brochures.
- Constantly interacts with safety, regulatory and operations teams in the USA, China, and Europe.
- Constantly interacts with key opinion leaders (KOLs) in the USA and Europe, organizes Advisory Boards.
- Prepares Investigational New Drug Application (IND) submissions, prepares and participates in meetings with Food and Drug Administration (FDA).
SANOFI GENZYME, Cambridge, MA, Clinical Research Director (2020-2021)
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.
NOVO NORDISK, INC., Plainsboro, NJ (2005-2009), Senior Director / Director / Associate Director – Clinical Development (2009 – 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 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 FDA, participated in BLA submissions and label preparations.
- Presented at international congresses and symposia. Represented Company at national and international meetings.Wrote manuscripts and abstracts
Study Director / Senior Staff Scientist / Staff Scientist (2005 – 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
MOUNT SINAI SCHOOL OF MEDICINE, New York, NY , Consultant – Department of Emergency Medicine(2008-2009)
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
UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY (UMDNJ) – MEDICAL SCHOOL, Newark, NJ (2000-2005)
Clinical Research Coordinator – Department of Surgery (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).
Hemophilia and Rare Bleeding Disorders, Red Blood Cell Disorders and Blood Transfusion, Cardiovascular, Surgery, Neurology, Rehabilitation, and Pediatrics.
author have more than 253 publication , 1 Papent and 175 presentation