James Warren

Commander
DISC Type : D

SVP, Global CMC Development at Ultragenyx

Greater Boston, United States

Overview

James is a pharmaceutical executive with 30 years of experience, currently serving as SVP of Global CMC Development at Ultragenyx. He is an expert in advancing vaccines, viral vectors, and gene therapies, leading large scientific teams from early development through to licensure. He holds a PhD from Lehigh University.

Outside of his biotech career, James is a Lieutenant Commander in the U. S. Navy Reserve, where he serves as an Executive Officer for a warfare analysis unit. His interests include the U. S. Naval War College and the Harvard Business Review, reflecting a focus on strategy and leadership in both his professional domains.

He has a unique dual career as both a senior biotech executive and a ranking officer in the U. S. Navy Reserve.

Personality Overview

Candid & Clear

Impact-Driven

Risk-Taker

They respond better to strong and respectful interactions.  They are less concerned about the product and more about its potential impact. They put a lot of effort into ensuring personal success.

Topics They Care About

Gene Therapy CMC
As the head of Global CMC Development, he focuses on the strategy for bringing new gene therapies, viral vectors, and biologics from development to licensure.
AAV Bioprocessing
He and his team frequently present at industry summits on developing intensified and scalable AAV production processes to improve yields and reduce costs.
Accelerated Drug Approval
He has delivered keynotes on CMC planning and execution specifically to support accelerated approval pathways for new medicines, showing an interest in speed to market.

Media Appearances

James Warren, Ph.D. – Ultragenyx Pharmaceutical Inc.. Featured in Informa Connect (Bioprocess International)

See Now

Work History

2-2024
SVP, Global CMC Development at Ultragenyx
2024
SVP, Head of Engineering and Manufacturing at Amlogenyx
4-2019 - 2-2024
Vice President, Pharmaceutical Development at Ultragenyx
5-2018 - 3-2019
Executive Director, Pharmaceutical Development at Ultragenyx
6-2016 - 5-2018
Vice President of Manufacturing at Homology Medicines, Inc.

Education

2000 - 2006
PhD from Lehigh University
2013 - 2016
Diploma: College of Naval Command and Staff from U.S. Naval War College

More Information

Social Presence :

Prographics :

Exp : 31 Location : Greater Boston, United States Job Level : Leadership Designation : SVP, Global CMC Development at Ultragenyx
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Insights For Selling To James

During A Call Or A Meeting

DO's

  • When negotiating terms, help them build an impression that they are the ones calling the shots
  • Hold your ground without indulging in one-upmanship
  • Objectively showcase the impact that your product creates

DONT's

  • Don’t take too much time in sending them information if they ask for any
  • Don't try too hard to forge relationships with them
  • Don’t focus on process and rules, give the impression of being a ‘gets it done’ person

When Cold Calling

When Writing An Email

While Negotiating & Closing

    The secret to closing fast with James is

  • Conviction around the impact matters the most to them, followed by a sense of achievement and ROI.
  • Will you ever get a clear answer from James

  • If they decide not to use your product, they will say no clearly.

Insights For Deal Planning

    How fast (or slow) will James move?

  • If convinced, they can reach decisions quite fast.
  • Can James take some risk or not?

  • They do not shy away from taking risks, but can be quite binary about them.

You And James

Personality Compatibility


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