AMIN VAKILIPOUR, MD, MBA

** ******* ***, *******, ** • 215-***-**** • ad2pl4@r.postjobfree.com

Senior Clinical Scientist

CLINICAL TRIAL MANAGEMENT • CLINICAL RESEARCH • TRAINING & MENTORING STUDY PROTOCOLS • BUDGETS • DATA ANALYSIS • COLLABORATION & INNOVATION PROFESSIONAL EXPERIENCE

Senior Clinical Scientist- Pandemic and Seasonal Influenza Vaccine CSL, Behring, Summit, New Jersey 2/2022 - Present

• Author protocol and master/model Informed Consent Forms and amendments.

• Oversee the Medical Monitoring Plan.

• Review CRFs, supervised protocol deviations categorization, and assessed their impact on the analysis.

• Handle safety-related communications, including Investigator's Brochure (IB) changes, with Investigators, and Institutional Review Board/Independent Ethics Committee (IRBs/IECs).

• Review and approved Statistical Analysis Plan (SAP) and TLF shells.

• Responsible for addressing protocol questions/clarifications from sites, oversight monitors, and vendor staff.

• Provide input into country/site feasibility and selection.

• Co-author First Interpretable Results (FIR)/Top-line results report with Biostatistics. Clinical Research Scientist- Oncology

Merck, Rahway, New Jersey 4/2021 - 1/2022

• Reviewed and interpreted medical data for accuracy, extracted from JREVIEW, and raised queries as necessary.

• Ensured data collection aligned with the protocol based on US regulatory standards, ensuring clean eCRF data.

• Contributed to the development of the Medical Monitoring Plan (MMP) and reviewed SAE reports.

• Reviewed and updated informed consent documents.

• Provided scientific input to support data management activities (e.g., EDC, DRP, CRFs).

• Co-authored newsletters with the Study Manager (SM).

• Assessed and prepared a protocol deviation list for CSR.

• Provided clinical specifications to SM for interactions with external vendors. Clinical Data Safety Scientist- Oncology

Eisai, Woodcliff Lake, New Jersey 11/2019 - 3/2021

• Generated Clinical Summaries for subjects.

• Reviewed safety data within the Clinical database by generating clinical summaries.

• Collaborated with study teams across therapeutic areas on safety-related matters. Advisor and Research Consultant (Freelancer)

Self-employed 10/2018 - 10/2019

• Advised, guided, and supported scientists to improve scientific publications and optimize clinical trials.

• Served as a peer reviewer for endocrine journals leveraging an excellent medical background. Clinical Scientist

ICON plc, Early Phase Service, San Antonio, Texas 2/2016 - 12/2017

• Spearheaded full-scope clinical projects, including staff training, mentoring, timelines, source documents, budgets, protocols, vendor negotiations, and final study reports.

• Worked closely with sponsors to review protocols and write amendments as needed, handled vendor negotiations, and managed budgets.

• Conducted scientific literature reviews, IRB submissions, data analysis, and addressed deviations in collaboration with medical directors.

• Supervised personnel in preparing timelines, SOPs, and ICF, and resolved deviations, adhering to FDA, ICH, and GCP guidelines.

Clinical Data Associate

DOCS Global, contracted with Abraham Cancer Center, University of Pennsylvania, Philadelphia, PA 2015

• Explored autologous stem-cell transplantation in multiple myeloma patients and Phase 1 study of chimeric antigen receptor-modified T cells in patients with mesothelioma.

• Aligned eCRF with protocols in collaboration with principal investigators and study management personnel.

• Audited data, notified team members regarding deviations, and created reports for principal investigators and sponsors.

Clinical Research Coordinator

University of PA, Perelman School of Medicine, Division of Rs and Renal Electrolyte and Hypertension 2014

• Conducted various studies, including Chorionic Renal Insufficiency Cohort funded by NIH, Systolic Blood Pressure Intervention Trial funded by NIH, cardiovascular effects of sunitinib therapy, and Down's Syndrome metabolic health study.

• Enrolled patients, reviewed ICF, generated source documents, entered data into the computer, notified principal investigators of deviations, and submitted regular reports to NIH. Postdoc Researcher

University of PA, Division of Cardiovascular, Department of Medicine, Perelman School of Medicine 2012 - 2013

• Published articles and papers in medical journals and conferences with guidance from medical references and content.

• Received an award as one of the top ten papers at the 30th Annual Meeting of ASMBS at Obesity Week, Atlanta, Georgia, Nov. 2013.

• Gained experience in medical writing, literature database search, and ensured scientific accuracy of publications, including statistical sections.

• Investigated the effects of Exenatide and Liraglutide on Ischemic heart disease and heart failure on pigs and dogs; critically interpreted data and created posters for presentation. Volunteer Researcher

University of PA, Division of Cardiovascular, Department of Medicine, Perelman School of Medicine 2012

• Examined CPAP, weight loss, or both to regress ventricular remodeling in obese subjects; time-resolved left ventricular myocardial stress in heart failure with reduced ejection fraction revealed a marked increase in late systolic myocardial loads.

• Measured blood velocity and pressure in cardiac imaging using new software; identified and corrected software defects to increase accuracy by 15%.

Senior Physician and Chairman

Ministry of Health and Medical Education, Behbahan City Health Center, Khuzestan, Iran 2006 - 2010

• Directed a team of 22 physicians, nurses, and physician assistants, enforced compliance with federal health policies, and increased the budget by 25% annually by collaborating with congressional representatives.

• Founded the Family Health Awareness department to increase public knowledge of population control, pap smear tests, and child vaccinations; successfully increased local community participation by 65%.

• Received the Outstanding Medical Doctor Award twice. EDUCATION

MBA, University of Texas-Austin, Austin, Texas 2016 - 2018 MD, Tehran University of Medical Sciences, Tehran, Iran President of Medical Students Association, 2000 – 2005 AMIN VAKILIPOUR, MD, MBA

33 Hunters Run, Oakland, NJ • 215-***-**** • ad2pl4@r.postjobfree.com Microsoft Office, MATLAB, SPSS, Sigma Plot, MedRAA, JReview,Oracle, Rave

Journal Articles

Elahi D., Galiatsatos P., Rabiee A., Salas R., Vakilipour A., Carlson O.D., Angeli F.S., Shannon R.P., Egan J.M., Andersen D.K. Mechanism of Type 2 Diabetes Resolution after ROUX-EN-Y GASTRIC BYPASS (RYGB). Journal of Surgery for Obesity and Related Disease, 2014.

Elahi D., Angeli F.S., Vakilipour A., Carlson O.D, Tomas E., Egan.M., Habener J.F., Shannon R.P. GLP-1(32–36)amide, a Novel Pentapeptide Cleavage Product of GLP-1, Modulates Whole Body Glucose Metabolism in Dogs. Peptides, 2014; 59, 20–24.

Abstracts

Vakilipour A., Carlson O.D., Elahi D., Egan J.M. FGF-19 Response to a Standard Test Meal in Bariatric Patients before and Three Months after Surgery. Endocr. Rev, 2013; 34, SAT-828. Vakilipour A., Angeli F.S., Carlson O.D, Chen L., Shen Y.T., Tomas E., Habener J.F., Shannon R.P., Egan J.M., Elahi D. GLP-1(32-36)amide, a Novel Pentapeptide Cleavage Product of GLP-1, Modulates Whole Body Glucose Metabolism in Dogs. Diabetes, 2013; 62, 1016-P.

Chandrashekhar R., Akers S., Vakilipour A., Shiva-Kumar P., Haines P., Jain S., Sail H., Witschey W., Ferrari VA, Chirinos JA. Time-Resolved Left Ventricular Myocardial Stress in Heart Failure with Reduced Ejection Fraction Reveals a Marked Increase in Late Systolic Myocardial Load. J. Am. Coll. Cardiol. 2013; 61(10_S), E613-E613. Chirinos J.A., Shiva-Kumar P., Chandrashekhar R., Haines P., Vakilipour A., Saif H., Witschey W., Pandya N.; Segers P., Ferrari V.A., Akers S. Relationship Between Arterial Load and LV Concentric Hypertrophy Assessed with MR. J. Am. Coll. Cardiol. 2013; 61(10_S), E1473-E1473. Chirinos J., Shiva-Kumar P., Chandrashekhar R., Desai S., P., Witschey W., Chandrashekhar R., Jain S., Saif H., Haines P., Broderick P., Geraci S., Vakilipour A., Rawat D., Ferrari V.A, Akers S. Assessment of Age- Related Arterial Stiffness with Magnetic Resonance Imaging. Circulation, 2013; 128(22 Supplement), A 18304.

Chirinos J.A, Shiva-Kumar P., Geraci S., Desai S., Chandrashekhar R., Jain S., Saif H., Haines P., Broderick P., Vakilipour A., Rawat D., Witschey W., Ferrari V.A., Akers S.. Relationship between Effective Arterial Elastance and Specific Measures of Left Ventricular Afterload. Circulation, 2013; 128(22 Supplement), A 18641.

Konda P., Zamani P., Kumar P.S., Peddireddy S., Desai S., Vakilipour A., Sarabu C., Rawat D., Broderick P., Chirinos J.A. Wave Reflections and Left Ventricular Mass in Aortic Stenosis. Journal of the American Society of Hypertension, 2014; 8 (4 supplement), e43.

Conference Presentations

Vakilipour A., Chen L, Angeli FS, Shannon RP, Shen YT. Native GLP-1 and its Metabolites Mediate Regional Vascular Effects in Conscious Dogs with Early Heart Failure. University of Pennsylvania, Department of Medicine Research Day, June 7th, 2013, Philadelphia, PA.

Chen L, Vakilipour A., Miedel E., Angeli FS, Shannon RP, Shen YT. Cardioproitective Effects of Saxagliptin, a DPP-4 inhibitor, in Myocardial Ischemia and Repurfusion in Conscious Pigs. University of Pennsylvania, Department of Medicine Research Day, June 7th, 2013, Philadelphia, PA. Haines P., Chandrashekhar R., Akers S., Vakilipour A., Shiva-Kumar P., Jain S., Saif H., Witschey W., Ferrari VA., Chirinos JA. Time-resolved Left Ventricular Myocardial Stress in Heart Failure with Reduced Ejection Franction reveals a Marked Increase in Late Systolic Myocardial Load. University of Pennsylvania, Department of Medicine Research Day, June 7th, 2013, Philadelphia, PA.

Shiva-Kumar P., Chirinos JA., Chandrashekhar R., Haines P., Vakilipour A., Saif H., Witschey W., Segers P., Ferrari VA., Akers S.: Relationship Between Arterial Load and LV Concentric Hypertrophy Assessed with MRI. University of Pennsylvania, Department of Medicine Research Day, June 7th, 2013, Philadelphia, PA. Elahi D., Galiatsatos P., Rabiee A., Salas R., Vakilipour A., Andersen DK, Mechanism of Reversed Glucose Intolerance after Roux-en-Y Gastric Bypass. (RYGB) joint meeting of ASMBS and the Obesity Society, (Obesity Week) November 11-16, 2013, Atlanta, GA.

Observerships

Department of Pathology, University of Pennsylvania, Perelman School of Medicine Division of Renal Electrolyte and Hypertension, University of Pennsylvania, Perelman School of Medicine Gastroenterology Division, Presbyterian Hospital, Philadelphia, PA Albert Einstein Hospital, Department of Medicine, Philadelphia, PA

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