* Biotechnology Program and Clinical Operations in global drug development leading to successful outcomes from pre-clinical to commercialization.* Project and Program Development Strategy infrastructure to support small biotech (Series A seed) to large biotech/pharmaceutical companies with valuation range of $1M to $1B* Strategy and hands-on team leadership to build cross-functional virtual collaborations within the pre-clinical development, CMC, Toxicology, Analytical and Bioanalytical, Clinical Operations, Regulatory, Biostatistics, Data Management, Programming, Pharmacovigilance, Medical Affairs, and 3rd party vendors.* Ensure late stage programs are BIMO and PAI inspection ready for a successful outcome.

Director oversight and hands-on leadership of a global team under a functional service provider model. Ensuring all vendors complied with ICH/GCP, local regulations, and respective vendor SOPs.

Operational Leader providing management oversight of Pharm-Olam's largest Phase 3 global clinical program with 70% of staff reporting in a matrix environment in 25 countries on 3 continents. Cross-functional leadership from financial management, feasibility, regulatory submissions, recruitment, data cleaning, analysis, writing, grant payments, and closure.