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Kathleen Walker

Kathleen Walker

Executive Director Regulatory CMC | Xencor

California, United States

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Kathleen Walker

Summary

Kathleen Walker is an accomplished Executive Director specializing in CMC Regulatory Affairs within the biotechnology sector. With a robust background in analytical chemistry and a proven track record in regulatory submissions, she has successfully led CMC development for both biologic and small molecule drug candidates. Her expertise spans across various stages of drug development, emphasizing compliance with global regulatory standards. Kathleen has held leadership roles in several prominent organizations, showcasing her ability to navigate complex regulatory landscapes. Her strategic mindset is complemented by a strong focus on cross-functional collaboration and team leadership. Kathleen is passionate about advancing pharmaceutical innovation and ensuring the safe delivery of new therapies to patients. Outside of her professional pursuits, she is likely to be involved in mentoring the next generation of scientists and regulatory professionals.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Innovation

Organisational experience

Corporate Experience

Kathleen Walker

Work Experience

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Executive Director Regulatory CMC at

Xencor

October 2022 - Present

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Senior Director, CMC Regulatory Affairs at

Xencor

January 2020 - Present

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Principal Consultant at

NDA Group - an SSI Strategy Company

January 2019 - January 2020

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Senior Director Chemistry, Manufacturing and Controls, Pharmaceutical Development at

La Jolla Pharmaceutical Company

January 2016 - January 2018

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Site Head, Regulatory Affairs, Biologics CMC at

Gilead Sciences Austria

January 2014 - January 2016

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Director Scientific Consulting at

Cardinal Health Specialty Solutions

January 2008 - January 2014

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Director, Technical Operations at

HI-EISAI PHARMACEUTICAL, INC.

January 2006 - January 2008

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Director Technical Support at

Ligand Pharmaceuticals

January 2003 - January 2006

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Assistant Director at

Ionis Pharmaceuticals, Inc.

January 1996 - January 2003

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Kathleen Walker

Education

The Johns Hopkins University School of Pharmacology, Post Doctoral Fellow

Frequently Asked Questions about Kathleen Walker

What is Kathleen Walker email address?

Kathleen Walker's primary email address is *******@xencor.com. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Kathleen Walker work for?

Kathleen Walker is a Executive Director Regulatory CMC at Xencor, a company specializing in Commercial physical research.

Where Kathleen Walker graduated from?

Kathleen Walker holds a degree in Bioanalytical And High Resolution Mass Spectroscopy from The Johns Hopkins University School of Pharmacology.

How can I directly contact Kathleen Walker?

To contact Kathleen Walker directly, you can use the email address *******@xencor.com. Complete contact information is available upon registration with Muraena.

Who is Kathleen Walker?

Kathleen Walker is an accomplished Executive Director specializing in CMC Regulatory Affairs within the biotechnology sector. With a robust background in analytical chemistry and a proven track record in regulatory submissions, she has successfully led CMC development for both biologic and small molecule drug candidates. Her expertise spans across various stages of drug development, emphasizing compliance with global regulatory standards. Kathleen has held leadership roles in several prominent organizations, showcasing her ability to navigate complex regulatory landscapes. Her strategic mindset is complemented by a strong focus on cross-functional collaboration and team leadership. Kathleen is passionate about advancing pharmaceutical innovation and ensuring the safe delivery of new therapies to patients. Outside of her professional pursuits, she is likely to be involved in mentoring the next generation of scientists and regulatory professionals.

Kathleen`s contact details

mail

*******@xencor.com

*******@ljpc.com

*******@abac.com

Colleagues

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Sophie Visonneau

Vice President, Head of Clinical Operations

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Robin Silva

Patent Attorney (retired but consulting for Xencor)

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Kirk Rosemark

Sr. Vice President Regulatory Affairs and Quality Assurance

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Shelley Belouski

Executive Director, Nonclinical and Bioanalytical Development

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Eric Kowack

Vice President, Program Leadership and Strategic Alliances

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Julie Casciani

Executive Director, Human Resources

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Bart Burington

Vice President, Biometrics

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Charles Reichel

Executive Director, CMC Operations – Drug Product and Supply Chain

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Frances Rena Bahjat

VP Discovery Biology and Pharmacology

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