Esha Pandey

Clinical Scientist @Merz Aesthetics

Collaborated with cross-functional teams, including data management, regulatory affairs, commercial, and clinical operations to design and execute clinical studies and to optimize workflows for digital data capture and analysis.• Developed and authored strategic clinical protocols, Investigator Brochure (IB), Clinical Study Report (CSR), and Informed Consent Form (ICF) to ensure alignment with FDA standards, contributing to key components of the Clinical Development Plan (CDP) for early-phase and late-phase studies• Designed and executed clinical studies across various development stages, including site feasibility, study start-up, investigator meeting/training, execution, and close-out activities• Contributed to global regulatory submissions (PMA, Qsub, IDE, 510k) by drafting and reviewing clinical sections in alignment with GCP and FDA standards• Served as the primary clinical lead during a strategic in-person FDA meeting, collaborating with regulatory counterparts to align trial design and development strategy with FDA expectations• Conducted medical monitoring to ensure subject safety, supported CRF design and query resolution during clinical data review cycles• Utilized electronic data capture (EDC) systems such as Medidata and Clincase for data management and analysis.• Interacted with cross-functional teams (Biostatistics, Safety, Regulatory, Data Management) and external stakeholders (study sites, CROs, KOLs) to ensure protocol compliance and trial success• Presented clinical data at advisory boards and scientific meetings; summarized top-line results for R&D leadership, including the Chief Scientific Officer (CSO), influencing strategic R&D decisions.