◆ Managing 7+ clinical trials, focusing on study design strategy and clinical writing to support Philips' patient monitoring business.◆ Collaborating with cross-functional teams, including R&D, Regulatory, Quality, and Clinical Operations, to manage complex projects and meet project milestones on time and within budget.◆ Authored 20+ clinical study documents, including clinical evaluation protocols, investigator's brochures, consent forms and site training materials, ensuring compliance with regulatory and GCP standards.◆ Working closely with engineering and data management teams to interpret data, author clinical study reports and communicate findings to key stakeholders.◆ Serving as a subject matter expert to support complex clinical programs, manage document timelines and resource planning to ensure timely regulatory submissions.

◆ Managed the clinical study design, execution and data analysis for 5+ clinical trials to support global regulatory submissions.◆ Acted as the primary clinical and scientific expert during interactions with KOLs, SMEs, health authorities, clinical sites, study vendors and CROs, ensuring efficient study conduct.◆ Authored several clinical study documents including preclinical feasibility designs, clinical plans, study protocols, ICFs, CRFs and clinical study reports.◆ Collaborated closely with Clinical Affairs, R&D, Regulatory and Product Management teams to launch successful products.

◆ Led clinical studies for the rapid detection of multiple infectious diseases on a Point of Care IVD testing platform.◆ Ensured adherence to GCP regulations and provided clinical inputs for FDA EUA and 510(k) submissions. ◆ Led the scientific study design and authored several clinical study protocols and reports, ensuring that study objectives were met within project timelines and budget.

◆ Developed 12+ IVD diagnostics assays for cancer diagnosis on an automated tissue-based staining platform for immunohistochemistry (IHC) and in situ hybridization (ISH). ◆ Managed full product development lifecycle from assay feasibility studies to design transfer, ensuring regulatory compliance and product quality.◆ Gained in-depth knowledge of FDA and ISO regulatory requirements, risk mitigation strategies and Quality Systems.◆ Collaborated closely with product management and engineering teams, ensuring that the product claims are customer-focused and in compliance with regulatory guidelines.

◆ Contributed to the newly emerging COVID-19 pandemic as an Immunology expert to accelerate the development of COVID-19 antibody diagnostic tests using oral fluids. ◆ Analyzed complex clinical data resulting in 2 FDA EUA submissions and 4 publications in reputed journals (Nature Sci Rep, JCM).◆ Collaborated with a team of 10+ scientists on multiple complex projects, reviewing study design, protocols and reports.◆ Presented study findings and troubleshooting strategies to key stakeholders, ensuring clear and efficient communication.

◆ Conducted research on lung inflammation pathways and the function of GSDMB in asthma. Published key findings in PNAS, one of the top 4 journals in the field.◆ Led multi-disciplinary team projects to understand lung inflammation and fibrosis pathways, resulting in 8 journal publications (JACI, JI) and 3 invited review articles.◆ Won 2 oral presentation awards at international conferences featuring 50+ speakers, demonstrating outstanding communication skills.