Head of Clinical Operations for the Cell Therapy Solid Tumor portfolio

• Develop program timelines and budgets and manage variance • Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans • Identify program risks and develop and implement mitigation strategies for assigned programs • Define the resourcing and outsourcing strategy for early development programs • Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders

Create and oversee project timelines and budgets, manage competing timelines and prioritize critical tasks.Responsible for financially managing overall programs and highly complex, large volume trial budgets, determining the methodology for forecasting each account.Responsible for the leadership of the monthly budget review meetingLeads strategic project planning and execution tracking for Clinical OperationsUnderstand strategic & operational goals and creates & aligns cross functionally on a plan for execution and completion of the plan and goals in agreed upon time frame.Track and report progress against plans using project management tools available or by creating appropriate tracking and metrics reporting tools.

-Ensures all trial deliverables are met according to timelines, budget, operational procedures and quality standards-Supports the development and implementation of medical education materials for a large phase III trial by working with an agency to create site toolkits/ marketing materials and tailoring these materials to meet study needs helping build the bridge between marketing and the science of clinical trials-Manages the development of key trial presentations and posters at international congresses, investigator / steering committee meetings by interfacing with senior management and internal/external authors (KOLs)-Direct project management responsibilities of Contract Research Organizations and ensures adherence to scope of work within timelines and budget-Establishes team communication and escalation plans-Participated in and significantly contributed to a FDA NDA submission -Responsible for development of study timelines, budget forecasting and total trial grant approvals, including the development and management of vendor contracts -Works seamlessly with the different functional areas participating in this large clinical trial-Contributes to the ongoing scientific review of the clinical data and support trial data analysis, reporting and publishing-Main contact for managing/answering questions related to trial procedures and patients’ eligibility-Excels in a fast paced, pressurized situation

-Provided strategic leadership to help determine strategy for future indications of particular products-Management of all aspects of study conduct, including development of protocols, clinical study reports, case report forms and completion guidelines, study manuals, contract and budget templates-Responsible for the development and execution of project timelines, project plans, and study budgets -Developed and demonstrated effective relationship management with KOLs-Provided training to CRAs, including development of monitoring guidelines and tools -Contributed to the preparation and resolution of internally conducted audits and the development of new departmental SOPs

CRO Program Manager