Essai Mahalingam
Global Clinical Project Manager @礼来
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WORK HISTORY
Global Clinical Project Manager @礼来
Lead cross functional teams to develop late phase oncology molecules from asset strategy, clinical strategies, life cycle plans, late phase registration scenarios to global regulatory submissions. Manage multi-million dollar clinical development budget and provide direction and oversight for global clinical trial teams to meet milestones on time, on budget and within scope.•Recognized with Lilly’s prestigious 2016 “Top 100 Innovator” award for work in accelerating development of an oncolytic drug through the novel design of clinical trials.•Developed, and implemented clinical plan, clinical trial timelines, clinical risk management plans, and proactive risk management from the start of a clinical development program until closure. •Lead multiple cross-functional global regulatory submissions (FDA, EMA, PMDA) and downstream activities supporting launch. •Established partnerships and effective working relationships with external vendors.•Clinical Operations contact for in-licensing and due diligence activities. •Collaborated with other pharmaceutical companies in developing and executing novel-novel combination trials, including immuno-oncology trials. •Subject matter expert (SME) on Clinical Costing and Oncology Disease state benchmarks. •Coach, mentor, and provide on boarding training for Clinical Project/program Managers.•Microsoft Project Critical Chain Professional Certification
EDUCATION
University of Waterloo
Bachelor of Science
ABOUT ESSAI MAHALINGAM
Top 100 Innovator by Eli Lilly and Company; I am a Clinical Program Leader with >15 years of pharmaceutical experience who is passionate about successful clinical development based on the unique scientific attributes of an asset aligned to the patient\'s needs. I have extensive experience in strategic planning and execution of a global clinical development programs and leading and managing cross-functional matrix teams from Ph I through Ph IV development in oncology, diabetes, neuroscience, critical care, and cardiovascular care. I am notably known for the ability to empower, influence and lead decisively in the mist of ambiguity, leveraging strong leadership, project management skills and learning agility in order to deliver results with speed, quality and value. Specialties:People management, product development, business planning, clinical development strategy and execution, sourcing strategy, life cycle planning, global regulatory submissions, trial management and monitoring.
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