David Skarinsky

**Matrix strategic development and team leadership execution in the fields of innovator drug and biologics, plus generic/biosimilar development from preclinical to commercialization
**32 years of cross-therapeutic, Phase I-IV, multinational development leadership including project planning & risk management, global regulatory affairs development strategy, extensive clinical operations and project/program management, quality systems and efficiency, process development, technical writing, and data management expertise
**Multi-region global regulatory expertise and consulting overseeing regulatory strategy, technical execution, meetings, special designation requests, special population development and submissions
**Multi-therapeutic expertise in neurology, psychiatry, infectious disease, urology, GI, oncology and dermatology.