Responsible for supporting Chief Medical Officer in developing a proactive enrollment plan at clinical trial sites and their referral centers to enable rapid and timely subject enrollment at the target rate along with developing educational materials to support patient screening and enrollment for the individual clinical sites. My responsibilities included:● Supported enrollment and recruitment activities● Reviewed all screening documents to assure that all subjects were eligible prior to randomizing● Managed the randomization schedule to assure that all subjects were assigned to the correct treatment regimen● Provided technical expertise to support the ELAD team (nurses trained to run the device at the clinical sites) as well as the principal investigators, other ICU physicians and nurses as well as other research staff● Assisted Medical Monitor with pharmacovigilance● Supported medical science liaison team● Supported efforts to develop strong relationships with key opinion leaders (KOL’s) ● Developed and finalized educational materials for the clinical trial ● Worked with clinical operations and consultants to support reimbursement strategy● Developed relationships with key organizations such as AASLD, EASL, ALF, and SCCM● Maintained updated medical/scientific knowledge of liver disease via literature review, , attendance to advisory boards, and key medical congresses (e.g., AASLD, EASL, etc.)● Developed and managed a strategic medical education plan for target professional audiences

Responsible for supporting Chief Medical Officer with clinical content, technical expertise, training, patient management, representing the company at external events, and contributing to the overall success of multiple clinical trialsAssisted executive management with medical aspects of clinical studyKey role in clinical trial protocol development, revisions, and training internal staff and external sites as neededDeveloped training materials for all study protocolsEnsured protocol compliance at clinical sites Supported enrollment and recruitment activitiesReviewed all screening documents to assure that all subjects were eligible prior to randomizingManaged the randomization schedule to assure that all subjects were assigned to the correct treatment regimenWorked with clinical operations to support prestudy visits and site initiation visits, developing relationships with study coordinators and principal investigators, liaising between study site staffProvided technical expertise to support the ELAD team (nurses trained to run the device at the clinical sites) as well as the principal investigators, other ICU physicians and nurses as well as other research staffAssisted Medical Monitor with pharmacovigilanceReviewed Serious Adverse Events and data, providing analysis and information to Medical MonitorDeveloped relationships with key organizations such as AASLD, EASL, ALF, and SCCMMaintained updated medical/scientific knowledge of liver disease via literature review, , attendance to advisory boards, and key medical congresses (e.g., AASLD, EASL)Provided training on approved materials to promotional speakers and KOL’sAssisted CMO in developing new KOL’s and identifying prospective sites and partnersWorked with Marketing, Clinical and other departments to provide Medical Affairs input and approval for educational materials, slide sets, training materials, and other marketing materials that contain medical or product information. Developed SOP’s

VTI developed the first human liver cell based biologic liver support system, ELAD®• Managed daily operations, conducted assessments and performance evaluations at 32 clinical sites in the US, UK, EU, Singapore, Saudi Arabia and China during Phase II/III clinical trials involving ELAD® in subjects with Acute on Chronic Hepatitis, Acute Alcoholic Hepatitis and Fulminant Hepatic Failure• Collaborated with senior management to establish and mobilize the ELAD® trial design, including formulating the study, drafting/evaluating protocol, investigating outcomes, ensuring regulatory compliance and assisting in all other aspects of multiple human study clinical trial work• Drafted ELAD® Standard Operating Procedures and Operator’s Manual in collaboration with chief scientist and engineering department • Developed training and certification program for ELAD® Specialists; trained and managed clinical team, both domestic and international, including directly supervising 9 ELAD® Specialists, 4 CRA’s and controlling clinical team budget of ~$6.5 million• Oversaw 19 US, 7 UK, 1 Denmark, 1 Saudi, 2 Singapore and 2 China investigational clinical study sites, which included direct responsibility for regulatory compliance, pre-study site assessments, Western IRB protocol submission, ICF approval for local IRB’s, site initiation, monitoring and study close-out visits• Negotiated contracts and budgets with clinical sites and vendors; controlled all final study related clinical site/vendor invoicing• Provided 24/7 technical and logistical support related to the conduct of the study and operation of the ELAD® System• Conducted scientific/clinical presentations for clinical site medical, nursing and research staff

• Drafted guidelines for human investigational clinical trial work in the area of acute liver failure• Assisted with design, development/testing and operation of ELAD® System; drafted Operators Manual with chief scientist and engineer• Acted as Senior ELAD® Specialist at 2 Beijing, China hospitals during Phase III trial; diagnosed and solved technical issues related to operation of ELAD® System• Trained and supervised Chinese clinical site nursing staff ELAD® Specialists; educated Chinese Principal Investigators and medical staff; facilitated successful communication between company and Principal Investigators and staff to ensure efficacy during subject enrollment• Achieved statistical significance in transplant free survival for treated subjects and assisted in organizing data for marketing application to the Chinese SFDA

• Coordinated industry and grant sponsored research for Department of Critical Care Medicine• Assisted in directing studies, quantifying and compiling data and ensuring regulatory compliance• Documented study requirements and fulfilled both internal and external regulations in accordance with various protocol guidelines

Liver Transplant Intensive Care Unit and Cardiothoracic Intensive Care Unit• Staffed unit dedicated to helping some of the most medically compromised patients from around the world with end-stage organ failure• Operated as active multidisciplinary team member working towards continual improvement of the clinical, scientific and social aspects of transplantation to improve the lives of patients and families