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)
- 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, Co-Founder, CEO 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 @ Intrexon Corporation (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)
- Director, Project Management, Clinical Team Leader @ (August 1995 - October 1999)
- Manager, Clinical Research Administration and Orthopedics Laboratory @ (July 1994 - July 1995)
- Clinical Research Coordinator @ (August 1993 - July 1994)
James Kirwin Education
- 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 - Columbia University
Master of Science - MS ABT (Bioethics: Biotechnology, Pharmaceutics and Ethics)
2027 - Penn State University
Bachelor of Science (Microbiology and Immunology)
James Kirwin Skills
- 21 CFR Part 11
- Biopharmaceuticals
- Biotechnology
- CRO
- CTMS
- Cardiology
- Change Management
- Clinical Data Management
- Clinical Development
- Clinical Monitoring
- Clinical Operations
- Clinical Research
- Clinical Trials
- Commercialization
- Cross-functional Team Leadership
- Data Management
- Dermatology
- Diabetes
- Drug Development
- Drug Discovery
- EDC
- Endocrinology
- FDA
- GCP
- GLP
- GMP
- ICH-GCP
- IND
- Immunology
- Infectious Diseases
- Leadership
- Medical Affairs
- Medical Devices
- Medical Writing
- Neurology
- Oncology
- Performance Metrics
- Pharmaceutical Industry
- Pharmacology
- Pharmacovigilance
- Protocol
- R&D
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Submissions
- Sop
- Technology Transfer
- Therapeutic Areas
- Vaccines
- Validation
- Lifesciences
- Management Consulting
- 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 Telix Pharmaceuticals Limited, Arvinas, Iterum Therapeutics plc and New Millennium Gaming, LLC. James Kirwin holds a 2008 - 2009 Certificate in Operations Management and Supervision @ The Wharton School. With a robust skill set that includes 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CRO, CTMS and more. James Kirwin has 2 emails and 4 mobile phone numbers on RocketReach.
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