B.S. Microbiology, Purdue University
MBA, St. Mary's College of California
Regulatory Affairs Certification
Over 30 years of R&D, directing and implementing development of novel biopharmaceuticals and medical devices. Clinical, regulatory operations, and market strategies for commercialization.
Project and team management in all phases of development: Discovery, IND, clinical trials, NDA/BLA, and commercial launch, including FDA interactions with several therapeutic divisions.
Risk assessment (technical, regulatory, commercial, timelines and costs; Monte Carlo scenarios) and mitigation planning
Alliance management of development partnerships, domestic and international
Managed multi-million dollar federal research programs in pathogen inactivation and vaccines
University of California, Santa Cruz
- Program Chair, Clinical Trials Design and Management Certificate
- Science of Clinical Trials Design instructor
On-site training in clinical drug development
B.S. Business, San Francisco State
Over 30 years Human Resources experience. Positions up to Director for Cetus Corporation, Lucky Food Stores, Webvan, Clorox, Chiron/Novartis, & Onyx Pharmaceuticals.
- Director, Human Resources
- Compensation Analyst
- Executive Compensation planning for recruitment and retention for pre- and post-IPO biotechnology companies