2018 -2021 Associate Director, CMC Global Regulatory Affairs @
2013 -2018 CMC and Regulatory Affairs @ United States Food & Drug Administration
2011 -2013 COO @ Sapientia Pharmaceuticals
2002 -2011 Principal Scientist @
1996 -2002 Research Scientist @ 3 Dimensional Pharmaceuticals
1995 -1996 Project Manager @ Group Syndetic
1994 -1995 Business Development Analyst @ Johnson Matthey Pharmaceutical Services
1989 -1994 Staff Chemist @
1987 -1989 Research Scientist @
James Hoffman Education
Saint Joseph's University
MBA (Marketing)
1989-1991
Dickinson College
Bachelor of Science (Chemistry)
1983-1987
Dickinson College
Bachelor of Science - BS (Chemistry)
Dickinson College
Monsignor Clarke
James Hoffman Skills
Data Mining
Intellectual Property
Process Improvement
Change Management
Predictive Modeling
Quantitative Analysis
Data Analysis
Market Research
Strategic Planning
Drug Design
Technical Writing
Proposal Writing
HPLC
Sales
Writing
Substance
Patent Applications
Market
Chemical
Erb
Chemistry
Draft
Bacterial
Net
Infectious Diseases
Consideration
Clinical Research
Allocating
Access Control
Structure
Coupling
Competitive Intelligence
Patent Strategy
Business Administration
Adoption
Impurities
Symposium
Sbir
Co Authored
Natural Resources
Business Partners
Clinical Development
Treatment
Assessment
Activator
Search
CMC
Management
Proven Leader
Design
Autodesk Inventor
Science
Investigational New Drug
Aseptic Processing
Therapeutic Areas
Delivering Solutions
Patents
Hp Enterprise Solutions
Peptide Synthesis
HIV
Key Opinion Leaders
SAR
Initiation
Synthetic
Administrative Management
Candidate Selection
Publications
Public Speaking
et.al
Cardiovascular
Site Visits
Dermatology
Philadelphia
Bone
Guidance
Reaction
Process Validation
Bridging
Business Services
Education
Healthcare
Visualization
Strategy
Strategies
Oncology
Risk Management
Et. Al
Intermediates
Training
Policy
Point of Contact
Patient
Audience
Contract Negotiation
Policy Issues
Institutes
Diabetes
Medicinal Chemistry
Streamline
Proteases
Project Management
Product Development
Academic Background
Research
New Orleans
Stakeholders
OPs
Venture Capital
Investigation
R&d
Analysis
Surveillance
Suzuki
Laboratory
Letters
Antibacterial
R
Probe
Verizon
Barriers
Dimensional
C
Affinity
Kind
Applications
Client Services
Communication
Business Development
Schedules
Life Sciences
Active
Scientific
Safety
Business Intelligence Development Studio
Licensing
Summaries
Operations
Stage
Miller
Author
Drug Discovery
DMPK
Visibility
Marketing
Aligning
Clinical Software
Timelines
Business Intelligence
Project Planning
Project
Contractual Agreements
Facilities Management
Indications
Data Integrity
Bronze
Covering
Presentations
Spain
Usa
Therapists
Regulations
Banking
International
Business Units
CRO
Executive Management
Logic Synthesis
Forms
Reviews
Selections
Grants
Investments
ICH guidelines
Academic
Guidelines
Kol
Bridge Inspection
Compliance
San Francisco
Business Planning
Phase
Fashion
Agents
Pharmaceutics
Manufacturing
Internal Controls
Schneider
Libraries
Market Analysis
Scientific Management
Versatile
Budgets
Due Diligence
Pharmaceutical Industry
Problem Solving
Trading
Meetings
Synthetic Organic Chemistry
FDA
Evaluation
Databases
.NET
James Hoffman Summary
James Hoffman, based in Ardmore, PA, US, is currently a Vice President Regulatory Affairs at BriaCell Therapeutics Corp.. James Hoffman brings experience from previous roles at Poseida Therapeutics, Inc. (Roche), Poseida Therapeutics, Inc., Amicus Therapeutics and United States Food & Drug Administration. James Hoffman holds a 1989 - 1991 MBA in Marketing @ Saint Joseph's University. With a robust skill set that includes Data Mining, Intellectual Property, Process Improvement, Change Management, Predictive Modeling and more. James Hoffman has 2 emails and 2 mobile phone numbers on RocketReach.
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