Extensive leadership experience in early phase clinical research, having led several oncology project teams in a matrix environment, and led the design and conduct of early phase oncology clinical trials of small molecules, monoclonal antibodies, antibody-drug conjugates, and viral and cell based cancer immunotherapy, incorporating predictive and pharmacodynamic biomarkers and pharmacokinetic analyses established external collaborations for combination trials with agents including immune checkpoint inhibitors engaged in later phase development strategies of small molecule compounds/biologics broad knowledge of regulatory aspects of drug development process annual training/refreshers in GCP authored several protocols and IBs and participated in IND/CTA/CTN submissions, EDC development, data review and lead CSR preparations trained as a Cell and Molecular biologist with expertise in gene regulation, cancer drug development, cancer immunotherapy and gene therapy, host-virus interactions, immune response and cytokine signal transduction, viral and non-viral vector design and production for therapeutic gene delivery, including vectors for Th1-biasing cytokines for stimulating antitumor immunity.