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
Publications click here
30 years of human resources experience in biopharmaceutical and consumer goods industries. Specializing in compensation policies and strategies.
Former positions up to Director for Cetus Corporation, Lucky Food Stores, Webvan, Clorox, Chiron/Novartis, & Onyx Pharmaceuticals.