Lynn Schaich

Susan Manley

Sue Manley has over 25 years of pharmaceutical industry experience and has been consulting for 5 years.    Her most recent corporate experience was as Global Head of Regulatory Operations for Novartis Pharmaceuticals. She has a broad knowledge of the workings of the pharmaceutical industry with a focus on design and implementation of organizational processes to create harmony and efficiency across conflicting and inconsistent technical, cultural and geographic environments. Her experience includes managing transitions mandated by new regulatory requirements or company changes such as in or out licensing and mergers.  She has directed staff to manage world-wide regulatory submission preparation, coordinate due diligence and legal depositions and oversee outsourcing.  Her strong people skills have allowed success in team oriented “must do” environments.  She has a MS degree from Seton Hall University in Biology/Business and a BS degree from Indiana University in Biology.  

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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, PhD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

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

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, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, PhD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, 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, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

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

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Business Strategy & Management Support

Lisa Jansa, MBA

Martin Lafontaine

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA