Served as Clinical Operations representative on the cross-functional Product Development Team. Provided operational feasibility for the Clinical Development Plan (CDP), Developed and managed operational strategy, timelines, budgets and resource forecasts for assigned clinical programs. Led the cross-functional clinical team in clinical study execution to ensure program strategies were implemented, and corporate goals were achieved. Assessed clinical program risks, created risk registry, and… Show more Served as Clinical Operations representative on the cross-functional Product Development Team. Provided operational feasibility for the Clinical Development Plan (CDP), Developed and managed operational strategy, timelines, budgets and resource forecasts for assigned clinical programs. Led the cross-functional clinical team in clinical study execution to ensure program strategies were implemented, and corporate goals were achieved. Assessed clinical program risks, created risk registry, and identified risk mitigation strategies. Prepared and presented status reports to Funding Agencies, Program Management, and Product Steering Committee. Oversaw the clinical operation preparation of contract and grant proposals to secure external funding for assigned programs. Generated Statements of Work and led the Request for process for selecting and contracting external vendors. Managed oversight of external vendors associated with clinical studies, including tracking milestones and deliverables, budgets, contracts, invoices, relationship governance, and served as escalation point of contact. Collaborated in generating documents for applicable regulatory submissions, including pre-IND packages, IND packages, BLA summaries, and NDA summaries. Participated in and oversee the preparation and ongoing review of study documents (e.g., protocols, investigational brochures, consent forms, and study-specific materials). Provided input to the clinical development department budget, forecast, and resources planning. Ensured reporting of required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance). Developed and revised departmental SOPs to ensure continued compliance with ICH-GCP and regulatory updates. Led initiatives for continuous improvement in the Program Management Office (PMO). Supervised and mentored CRAs, Clinical Trial Managers, and Clinical Trial Management Associates. Show less