Leadership

Brian Oscherwitz, MBA, PMP

 

Areas of expertise: Project Management; Clinical, Regulatory, and Commercial Product Development; SOP Development 

 

Brian Oscherwitz has over 20 years of experience working alongside executive leadership to direct cross-functional teams of subject matter experts. He has led teams in the completion of a wide range of projects, including new product development, commercial launch programs, global regulatory filings, process improvement initiatives, and portfolio and corporate integrations.

 

Brian’s project management expertise spans several areas, including directing the clinical operations of several pharmaceutical companies. As a member of Shire Pharmaceuticals’ Clinical Operational Excellence & Support team, Brian led a novel Risk Management & Clinical Trial Oversight model designed to transform global Clinical Operations while enhancing comprehensive project quality and ICH E6 R2 compliance. Brian also led generic clinical development programs for Biovail Technologies, Inc., and for development/clinical-stage companies Reata Pharmaceuticals and Constellation Pharmaceuticals.

 

Brian has also demonstrated a breadth of regulatory and commercial product development leadership. He managed the planning and timelines for global regulatory filings for high priority cancer therapies with Genentech Inc. He led Global Expansion teams at Hospira/Pfizer to make domestically approved injectable products available to patients in Canada, EMEA, LATAM, MENA, APAC, and CEE. During his tenure at Galderma Laboratories, a joint venture between Nestle, Switzerland, and L’Oreal, Paris, Brian introduced and propagated the organization’s North American project management office. He established the policies, processes, enterprise-wide tools, and training needed to optimize the management and execution of projects ranging from co-development initiatives to M&A projects.

 

Brian’s organizational management also includes identifying process improvement opportunities. He led the Global Supply Chain improvement initiative at Astellas Pharma US, Inc., as well as the Clinical Operations and Promotional Material review process refinement projects at Galderma Laboratories LP.

 

To immerse himself more deeply in every dimension of biopharmaceutical endeavors, Brian spent 10 years in the CRO sector supporting clinical trials in project management, investigator relations, and bids & contracts roles at Pharmaceutical Product Development (PPD). He also developed expertise in the Patient Recruitment and Retention discipline with D. Anderson & Company.

 

Brian provides Kinexum with insight gained from his experience leading teams of contributors with roles ranging from Clinical Research Associate to CEO; and representing a multitude of operational disciplines worldwide. Brian’s experience in developing and leading project initiatives – from pre-clinical to launch – for clients across the CRO, patient recruitment/retention, consumer product, pharmaceutical, and biotech sectors also spans from startup to big pharma.

 

Brian received his MBA with a concentration in the Management of Technology from The University of Texas at San Antonio, and his BA in Microbiology with an emphasis on Immunology from The University of Texas at Austin. Brian is also PMP-certified through the Project Management Institute (PMI).

 

 

Leadership List

Officers

G. Alexander Fleming, MD
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Doug Muchmore, 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

Mustafa A. Noor, MD, FACP

Peter Damsbo, MD

Ramachandra (Ram) G. Naik, M.D.

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Strategy and Operations

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Dia Hill

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D

Susan Manley, MS

 

Biostatistics

Alan Fisher, DrPH

 

EU Regulatory

Catherine Bernard, Ph.D

Gabrielle Wiederkehr, MSc

Michael Trautmann, MD

 

Clinical Operations/Project Management

Brian Oscherwitz, MBA, PMP

Chris Yun, B.S.

Gabrielle Wiederkehr, MSc

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

Susan Manley, MS

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Michael B. Zemel, Ph.D.

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

 

QA/QC

Brian Oscherwitz, MBA, PMP

Jennifer Zhao, B.S.

 

Medical Writing/Electronic Submissions

Jennifer Zhao, B.S.

Kristi Hultberg, B.S.

Sandor Bernath, Ph.D, MBA

 

Botanicals

Jinhui Dou, Ph.D.

 

Government Relations and Public Affairs

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.