Siddharth Parulkar

Background

About Siddharth Parulkar

With a Master’s degree in pharmacy (M. Pharm) an advancing clinical research professional with over 17 years of industry experience (Pharma, Biotech and CROs) in managing, supervising and monitoring global multi centric clinical studies through Phase I, II and across multiple therapy areas i.e. Oncology, Neuropsychiatry, Nephrology, Hematology/ Immunology/Infectious diseases, Rheumatology and Ophthalmology. Over 6 years of core experience in project management working with Startup, Midsize and large Pharmaceuticals/Biotech Companies. As a trial manager, seasoned in supporting NDA submissions and successfully managing an FDA Inspection. Strong leadership, planning and project management skills; ability to lead cross-functional and cross country teams in a matrix driven environment ensuring strict adherence with timelines, costs and quality metrics are as per the project goals. Over 5 years of experience in managing global/ international clinical studies in challenging regulatory environments like North America (United States, Canada, Mexico), Latin America, Europe and Asia. A thorough understanding of clinical trial application process across above mentioned countries and experience in working on the entire life cycle of the drug development from preclinical studies, phases (I – IV) and post marketing surveillance. Efficient in management of clinical development program with strong cross-functional understanding of clinical trial methodology in managing Clinical Supplies, Data Management, Biostatistics, Medical Writing, Pharmacovigilance, Regulatory Affairs, expert panels, physicians and investigators, CROs, contract laboratories, advisory board committees, data safety monitoring board/Safety review committees and clinical trial consultants.