Dipti Kothari Email & Phone Number

South Brunswick Township, Nj, Us

Princeton, Nj

• Enable R&D leaders in Global Clinical Operations and Strategy, Central Clinical Services & US Site Management organizations to balance FTE resources across divisions, geographies and projects to achieve pipeline and business objectives by using resource forecasting models to translate workload demand into resource needs and evaluate relative to resource availability• Provide resource management support to Global Clinical Operations and Strategy, Central Clinical Services & US Site Management to enable effective book of work planning for over 100 projects and resource capacity planning for a headcount of ~200• Assess FTE needs of drug pipeline to support line functions in strategic resource planning• Generate insightful analyses and reports to provide stakeholder transparency into headcount capacity, time actuals, and resource forecasts against drug pipeline utilizing ePlan, MARS, Spotfire & Excel• Led analysis of resource scenario planning and identified $50M cost reduction by optimizing blend of outsourced and in house clinical studies. Identified constraints in staffing in several functional areas throughout R&D. Identified impact of new projects or alliances on resource capacity.• Conduct data analyses in support of decisions triggered by progression along PD&C process• Lead process to evaluate and recommend GDO clinical study starts approvals on a quarterly basis through collaboration with a broad group of management and operational areas • Support annual R&D budgeting process by providing robust resource analysis to aid in scenario planning and evaluation• Develop, test, deploy and manage algorithms for Protocol Managers, Outsourcing Managers & Clinical trial associates to aid in efficient book of work planning and capacity planning• Efficiently led various initiatives (staff meeting manager, budget working group, system migration, modeling forum manager etc.) that led to process improvements and change management

Princeton, Nj

• Generate and maintain accurate and well-constructed timelines in ePlan by collaborating with project managers and development teams in maintaining efficient and accurate schedules.• Deliver analytical, timeline and sub-team support to various development teams to support portfolio planning• Facilitate sub-team meetings and activities including issue identification and resolution.• Support MEC activities and conduct & identify activities that support data quality and integrity.• Support POCG & Portfolio budget process by ensuring accurate information is available for change requests, budget baseline and annual budget reports and analyses• Drive timeline related scenario planning for strategic planning and budget by collaborating across multiple functional areas.• Generate portfolio/TA level resource analysis to identify resource gaps• Participate in annual budget processes in updating timelines, revising/reviewing study driver information and projecting resource estimates.• Prepare timeline and resource reports for clinical pharmacology plan reviews, coordinate review of timeline and resource reports to reflect team’s current project plan.

Princeton, Nj

• Programming team lead for Anti-infective group in Phase I. Responsibilities include coordinating priorities across projects, resource allocation, managing work of team members and training & mentoring personnel.• Work with CRO by training, coaching, reviewing and validating to assure BMS standards have been maintained• Provide management/programming support by meeting aggressive timelines while maintaining integrity and accuracy of the output being delivered across projects.• Generate and validate ISS tables utilizing a rolling ISS system and create electronic submission data sets for filing• Support FDA & EMEA responses and provide support for Advisory Committee Meetings.• Provide programming support in setting, enhancing, and preserving standard systems.• Manage multiple projects across TA’s by coordinating project time lines, tasking programmers, developing standard SAS programs that affect the entire project/program and generating ISS• Provide SAS programming support to various functions for management analysis and reporting of data to the FDA from Phase I through Phase IV clinical drug trials.• Develop SAS applications to produce standard safety and efficacy reports for statistical analysis.• Perform cross-platform data transfers and utilize WP macros.

• Developed and documented SAS applications to review medical data for clinical drug trials.• Performed system testing according to test plans and requirements• Managed the Drug Dictionary

• Developed, implemented, and documented applications in RPG-II.• Supported daily computer operations and performed daily tape loads and backups.

• Developed applications on the Rapid Access Management Information System (RAMIS).• Developed and implemented FORTRAN programs to process health related data.