Scot Faulkner, MPA

Richard Paul, MD

Dr. Richard Paul is an actively licensed Internal Medicine M.D. with more than two decades of experience in drug development, regulatory affairs and clinical research. He has worked as a practicing physician, a pharmaceutical company development executive and CRO executive.  Rich’s experience spans medical safety, clinical research, and regulatory strategy. In addition to his generalized drug development knowledge, Dr. Paul has experience in metabolic, hematology, oncology, CNS disease including Pain, Parkinson’s Disease and Alzheimer’s dementia, respectively.

 

Dr. Paul started his career after securing his Medical Degree with post graduate work at Albert Einstein College of Medicine, NY, Rutgers University’s Internal Medicine Residency program and a Fellowship tenure at Harvard Medical School/Joslin Diabetes Center.  Following the postgraduate work, Rich enjoyed private clinical practice treating adults and juveniles with diabetes and metabolic diseases for over 9 years before transitioning into pharmaceutical research with Pfizer.  He has also held executive leadership positions in clinical research, regulatory and medical safety departments with Ergo Science, Grünenthal USA, Shionogi USA and Schering Plough Corporation.   Notably, Dr. Paul was the founding Managing Director of Grünenthal USA, establishing the subsidiary for Grunenthal GmbH of Germany.

 

 

Through the course of his accomplished career, Rich has served many clients and employers in the areas of scientific and regulatory consultation.  Dr. Paul has multi-divisional FDA experience having represented and participated with a number of Biotech and Pharmaceutical sponsors supporting Investigational and New Drug Applications with the US FDA and other international regulatory agencies.  Further, Dr. Paul has led global regulatory groups for two CROs and one biotech organization.

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Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

Christopher Kotsopulos, MS

Dia Hill

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D

Scot Faulkner, MPA

 

EU Regulatory

Catherine Bernard, Ph.D

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Diane Paul, MS, RN

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

David Bergstrom, Ph.D

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

Rob Walsh, MD

 

 QA/QC

Christopher Kotsopulos, MS

Joshua Sharlin, Ph.D

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Lynn Schaich

Robert Kaster, RPh., ASQ-CQA

 

Medical Writing/Regulatory Submissions

Dahlia Sperling

Russ Neubauer, Ph.D

Sandor Bernath, Ph.D, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Formulation Development

David Bergstrom, Ph.D

 

Business Strategy & Management Support

Stephen Casey, MBA

Lisa Jansa, MBA

Martin Lafontaine

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA