Our Leadership Team

We know your challenges and the solutions that work

The D2V Clinical team offers unique hands-on experience – we’ve done it, we’ve made the mistakes, and we’ve had the successes in both the US and China. Work with the team that has been in your shoes.

The right experience to propel you forward

Amanda Fu, M.D., M.S., MBA

CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Walt Cao, Ph.D.

CO-FOUNDER, PRESIDENT AND REGULATORY OFFICER

Vijay Reddy, M.D.

Chief Medical Officer

Jeffery Roe

Executive Vice President, Human Resources

Marwa Noaman

Clinical Operations Director

Vijay Reddy, M.D., Ph.D., CHIEF MEDICAL OFFICER

Vijay Reddy, MD, Ph.D., is the Chief Medical Officer of D2V Clinical.

Vijay has more than 25 years of clinical practice and biotechnology pharmaceutical industry experience in hematology, oncology and immuno-oncology. His background includes medical affairs leadership, clinical leadership of Phase I first-in-human trials for solid tumors, and the publication of more than 50 original research publications in high-impact peer-reviewed journals.

Vijay is responsible for medical oversight of protocol, site initiation, education and training of principal investigators; assessment of efficacy; data entry within D2V; development of study-specific manuals and plans; maintaining quality standards, support of all aspects of IRB/ERC and Regulatory Agency submissions; clinical input in interactions between the sponsor, the site and the FDA; and medical input internal audit and inspections.

Prior to his work with D2V, Vijay served as Vice President of Clinical Development for Actinium Pharmaceuticals from 2018 to 2022, Senior Medical Director of Medical Affairs at Pharmacyclics LLC from 2016 to 2018, Medical Director of Early Clinical Development for Medimmune, Astra Zeneca from 2015-2016, and Medical Director of Janssen Scientific Affairs for Johnson & Johnson from 2013 to 2015. He has served as a Professor in the College of Medicine at the University of Central Florida since 2012.

Vijay earned his M.B., B.S. (M.D. equivalent) from Madras Medical College in India and his Ph.D. in Immunology from the Memorial University of Newfoundland, St. John’s, in Newfoundland, Canada. He also attained Specialty Board Certification in Hematology from the American Board of Internal Medicine, Internal Medicine and Hematology Fellow of the Royal College of Physicians and Surgeons of Canada, and Internal Medicine from the American Board of Internal Medicine.

Vijay Reddy, M.D., Ph.D.

CHIEF MEDICAL OFFICER

Amanda (Meng) Fu, M.D., M.S., MBA CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Amanda is the Co-founder and Chief Executive Officer of D2V Clinical. She brings to the position a passion for driving significant growth in global clinical development for oncology, hematology and rare disease. Amanda has extensive international management experience in strategy, corporate development, and strategic planning. In addition, she has more than 20 years of experience as an outstanding strategic group leader in clinical development and clinical strategy. She has planned and executed global clinical trials from Phase I - IV on four continents and in more than 30 countries.

From 2015 to 2019, Amanda served as Vice President of Clinical Development at 3D Medicine and Senior Clinical Operation Lead and Clinical Scientist in Oncology at MedImmune, where her focus on both clinical development and operations was invaluable. In 2015 she served in Project Management at Pharmacyclics, an AbbVie-owned company, and was the Clinical Surveillance Team Lead for INC Research from 2010 to 2015. From 2008 to 2010, she was Team Lead for GE Healthcare, Diagnostic Cardiology, and Clinical Research Site Director for Complete Healthcare for Women. In addition, Amanda was General Manager and head of Clinical Development at Gleneagles CRC in Beijing, China, from 2004 to 2008 and an attending physician at Beijing General Hospital from 2000 to 2002.

She earned her Medical Degree from Jilin University, Norman Bethune Medical School, in China, and her MS in Health Services Research and Technology Assessment from the University of Sheffield in Sheffield, UK. Amanda also earned an MBA from Ohio University.

Amanda (Meng) Fu, M.D., M.S., MBA

CO-FOUNDER AND CHIEF EXECUTIVE OFFICER

Xianhua (Walt) Cao, Ph.D., PRESIDENT AND REGULATORY OFFICER

Xianhua (Walt) Cao, Ph.D., is the founder and President of D2V Clinical, where he provides more than 20 years of experience in drug discovery and development in both the pharmaceutical industry and the U.S. Food and Drug Administration. During this time, he worked extensively with NME NDA/BLA applications and more than 500 IND Phase I-III clinical trial protocols. Additionally, he worked on drug development and marketing application for both new chemical entities and new biological entities. Walt has invaluable experience in cell and gene therapy, early-stage project optimization and clinical translation, translational sciences, clinical pharmacology, pharmacometrics, clinical study design, and global regulatory strategies for new drug marketing applications.

Walt served six years as Senior Clinical Pharmacologist for the FDA from 2013 to 2019. Previously, he served as Senior Scientist II/III at Abbot/AbbVie from 2010 to 2013 and Senior Scientist at Boehringer Ingelheim, from 2007 to 2010.

Walt earned his B.S. in Microbiology and Immunology from the Department of Microbiology and Immunology, School of Life Sciences, at Wuhan University in Wuhan, P.R. China. He also earned an M.S. in Microbiology from the Institute of Microbiology, Chinese Academy of Sciences, in Beijing, P.R. China, and a Ph.D. in Pharmaceutics at the Division of Pharmaceutics, School of Pharmacy, at Ohio State University in Columbus, OH.

Xianhua (Walt) Cao, Ph.D

CO-FOUNDER, PRESIDENT AND REGULATORY OFFICER

Jill Loftiss, MHS, CHIEF DEVELOPMENT OFFICER

Jill Loftiss, MHS, is the Chief Strategic Officer at D2V Clinical. She brings more than 25 years of experience as an R&D Clinical Operations Leader in pharma, managing clinical operations specialists and clinical scientists. Over those two decades, Jill built a flexible, scalable outsource model with leading CROs to meet internal project demands and led teams to multiple successful BLAs, NDA, and sNDAs in Oncology.

Prior to joining D2V, Jill served as Director and Senior Director in Oncology Development at MedImmune/AstraZeneca from 2014 to 2020, where she was responsible for the execution of a diverse portfolio of immunomodulators, monotherapy, and novel-novel combinations, as well as other biological therapies. She also gained significant outsourcing expertise to manage a wide range of clinical CROs using the model she created. In addition, Jill spent 15 years with GlaxoSmithKline as Director of Global Clinical Operations in the Oncology Business Unit from 1999 to 2014. She got her start at BMS as a Clinical Research Scientist and at Quintiles as a Clinical Research Associate from 1996 to 1999.

Jill earned her BSN in Nursing at Indiana University and went on to earn her MHS in Public Health at Duke University.

Jill Loftiss, MHS

CHIEF DEVELOPMENT OFFICER

Jeffrey Roe, MBA , EXECUTIVE VICE PRESIDENT, HUMAN RESOURCES

Jeffrey Roe, MBA, is the Executive Vice President, Human Resources for D2V Clinical. He is a highly accomplished and results-oriented global HR executive with over 25 years of experience leading change and increasing organizational effectiveness within dynamic life sciences organizations. As a strategic business advisor, Jeffrey brings vast experience across multiple corporate functions, including HR, Finance, IT, Administration, M&A, Integration, and Facilities. He is skilled in performance management, leadership development, diversity and inclusion, talent acquisition, employee engagement and retention, and compensation and benefits planning.

Before joining D2V Clinical, Jeffrey served as Head of HR at M3 Wake Research during 2022, where he implemented strategies that increased diversity and inclusion by 15% and improved employee engagement by 20% and productivity by 10%. As Head of HR at Velocity Clinical Research from 2020 to 2022, he implemented succession planning and talent acquisition programs which resulted in a 20% increase in new hire retention. Jeff spent four years as Human Resources Executive Consultant for JMR Consulting from 2016 to 2020, and was the Vice President of Human Resources for Clinipace Worldwide from 2009 to 2016. Jeff served as Vice President, Human Resources for Transamerica from 2005 to 2006. His earlier career included HR roles at IQVIA and BTI.

Jeffrey holds an MBA in Business Administration from Baker University and a BA in Human Resources from Mid America Nazarene University.

Jeffrey Roe, MBA

EXECUTIVE VICE PRESIDENT, HUMAN RESOURCES

Marwa Noaman, CLINICAL OPERATIONS DIRECTOR

Marwa Noaman, MBA, is the Clinical Operations Director at D2V Clinical. She brings more than 16 years of experience as a clinical research professional, managing research facilities, sites, and clinical trials. During her time in project management, Marwa has built long-lasting client relationships and successfully managed and overseen trials from start-up to trial publishing.

Prior to joining D2V Clinical, Marwa served as Head of Center of Excellence in Oncology and Project Director at ProPharma Group and Veristat from 2020 to 2023, where she was responsible for building site networks to support sponsor needs. Her experiences gained in those roles include the management of solid tumor trials and combination device trials. She earned a significant portion of her expertise by conducting project management at IQVIA/IQVIA Biotech from 2012 to 2020. In addition, Marwa spent much of her earlier career with direct patient care supporting Phase I-III clinical trials from 2007 to 2012.

Marwa earned her B.S. in Behavioral Neuroscience at the University of Kansas and went on to earn her MBA in Project Management at Capella University.

Marwa Noaman, MBA

CLINICAL OPERATIONS DIRECTOR