Mahua Roychoudhury
About
Mahua Roychoudhury is from United States. Mahua is currently Vice President Clinical Operations at Candel Therapeutics, located in Massachusetts, United States. In Mahua's previous role as a Senior Director, Global Clinical Operations and Planning at Daiichi Sankyo, Inc., Mahua worked in United States until May 2025. Prior to joining Daiichi Sankyo, Inc., Mahua was a Global Clinical Development Director, Oncology Therapeutic Area, GSK Pharmaceuticals at GSK and held the position of Global Clinical Development Director, Oncology Therapeutic Area, GSK Pharmaceuticals at Waltham. Prior to that, Mahua was a Director-Trial Management, Clinical Operations at TESARO, Inc. (Acquired by GlaxoSmithKline, GSK), based in Waltham, MA from Sep 2016 to Jan 2019. Mahua started working as Director Clinical Operations at Flexion Therapeutics in Burlington, Ma in Sep 2015. From Sep 2008 to Sep 2015, Mahua was Clinical Research Scientist at Novartis Vaccines & Diagnostics. Prior to that, Mahua was a Manager, Clinical Programs at Novartis Vaccines & Diagnostics, Inc. from Sep 2008 to Feb 2011. Mahua started working as Clinical Project Manager at Shire Human Genetic Therapies, Inc. in Mar 2004.
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Mahua Roychoudhury's current jobs
Mahua Roychoudhury's past jobs
- Represent Clinical Operations function in core development teams to provide strategic input to clinical development programs including various clinical trial scenarios and associated risks and costs aligned with company goals - Select and hire vendors and manage their performance and quality metrics through contracts and periodic review meetings adjusting scope of services as needed - Provide line management within Clinical Operations. Develop internal and external resource strategy to support corporate and program goals for development compounds. Hire, mentor and retain clinical team members to achieve goals - Develop operational plans to ensure compliance to current regulatory guidance and GCPs - Develop and maintain productive partnerships with internal and external stakeholders (CROs, consortia, investigators) including communication plans and setting of program milestones. Maintain a positive culture and strong working relationships across organizational functions - Develop and update integrated program timelines and budgets through collaboration with internal and external stakeholders as required to support operational plan and lead clinical trial team meetings - Provide oversight and guidance to clinical operations teams, documents and processes to ensure patient risk-benefit is optimized - Report status of program milestones and escalate issues to senior management. Identify program risks and develop and manage mitigation plans -Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, monitoring plans, study reports and annual reports -Contribute to clinical operations functional excellence through process development and working groups
Lead the pivotal Ph 3 study of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) in intra-articular therapy for patients confronting osteoarthritis-related knee pain. Oversight of the CROs (project management, site management, data-management, central imaging) and management of the global study budget and direct reports. This study led to the marketing authorization approval of this product.
Senior member of clinical development organization, accountable for overall clinical trials in phases I to III, execution of trial objectives, management of trial timelines, authorship of trial documents, budget management, overall trial oversight in adherence with ICH-GCP and company SOPs. Contributes to clinical development plans, IND updates, clinical summaries for regulatory filing and clinical study reports. Supports process improvement.