James Kirwin Email & Phone Number
COO and Sr VP, Clinical Development @ SFA Therapeutics
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James Kirwin Location
- United States
James Kirwin Work
- COO and Sr VP, Clinical Development @ (March 2024 - Present)
- COO and Sr VP, Clinical Development @ (January 2024 - Present)
- VP, Clinical Operations @ (August 2023 - March 2024)
- Head of Global Clinical Operations @ (January 2020 - May 2023)
- VP, Clinical Alliances and Clinical Development Operations @ (January 2018 - March 2020)
- CEO, Founder and General Manager @ (December 2014 - December 2017)
- Consultant and Senior Advisor, Clinical Development Operations @ (February 2011 - December 2017)
- VP Clinical Operations, Interim @ (January 2017 - September 2017)
- VP Medical Services @ (January 2014 - January 2015)
- VP Medical Affiars @ (January 2012 - June 2013)
- Vice President, Clinical Development Operations @ (January 2010 - January 2011)
- VP, Process Excellence (formerly Wyeth) @ (December 2009 - December 2010)
- Vice President, Global Development Operations( formerly Wyeth) @ (December 2008 - December 2009)
- VP Clinical Trial Operations (formerly Wyeth) @ (August 2000 - December 2007)
- Group Director, Global Clinical Affairs @ (August 2000 - December 2000)
- Manager, Clinical Research and Orthopedics Laboratory @ (July 1994 - July 1995)
- Director, Project Management, Clinical Team Leader @ (August 1995 - October 1999)
- Clinical Research Coordinator @
- Manager, Clinical Research Administration and Orthopedics Laboratory @ (July 1994 - July 1995)
- Clinical Research Coordinator @ (August 1993 - July 1994)
James Kirwin Education
- Columbia University
Master of Science - MS ABT (Bioethics: Biotechnology, Pharmaceutics and Ethics)
2016-2016 - The Wharton School
Certificate (Operations Management and Supervision)
2008-2009 - Alfred Lerner College of Business & Economics at University of Delaware
Master of Business Administration - MBA (Business Administration, Management and Operations)
1997-1999 - Penn State University
Bachelor of Science (Microbiology and Immunology)
James Kirwin Skills
- Clinical Trials
- Pharmaceutical Industry
- Biotechnology
- CRO
- Oncology
- Clinical Research
- Regulatory Affairs
- CTMS
- Lifesciences
- Infectious Diseases
- FDA
- Medical Devices
- Sop
- Vaccines
- Clinical Development
- EDC
- Change Management
- Management Consulting
- Clinical Operations
- Biopharmaceuticals
- Cross-functional Team Leadership
- Endocrinology
- Drug Development
- Drug Discovery
- Therapeutic Areas
- GCP
- Medical Affairs
- Cardiology
- Medical Writing
- Diabetes
- Protocol
- Data Management
- Neurology
- Clinical Monitoring
- ICH-GCP
- IND
- GMP
- Dermatology
- GLP
- Regulatory Submissions
- Immunology
- Validation
- Pharmacovigilance
- 21 CFR Part 11
- R&D
- Technology Transfer
- Pharmacology
- Commercialization
- Clinical Data Management
- Regulatory Requirements
- Development
- Ich Gcp
- Shared Services
- Cross Functional Team Leadership
- Marketing
- Training
- Product Development
- Research
- Services
James Kirwin Summary
- James Kirwin, based in United States, is currently a COO and Sr VP, Clinical Development at SFA Therapeutics. James Kirwin brings experience from previous roles at SFA Therapeutics, Telix Pharmaceuticals Limited, Arvinas and Iterum Therapeutics plc. James Kirwin holds a 2016 - 2016 Master of Science - MS ABT in Bioethics: Biotechnology, Pharmaceutics and Ethics @ Columbia University. With a robust skill set that includes Clinical Trials, Pharmaceutical Industry, Biotechnology, CRO, Oncology and more. James Kirwin has 2 emails and 4 mobile phone numbers on RocketReach.
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