Served as Clinical Science Lead for global Phase 3 study in Refractory Chronic Cough (CALM 2). Oversaw study execution in collaboration with clinical operations.- Key contributor to Phase 3 study designs, protocol development, and statistical analysis plans.- Developed global regulatory filing strategies and prepared responses to Institutional Review Boards (IRBs) and Ethics Committee (ECs).- Managed all Sponsor responsibilities for Phase 3 Data Monitoring Committee (DMC).- Led the Life Cycle Development Team, developing BLU-5937-line extension strategy in chronic cough.Represented Clinical Development in the assessment of novel cough counting devices.

Led multidisciplinary teams to assess commercial opportunities and validate drug targets. - Identified new therapeutic areas aligning with Vertex's corporate strategy and with >$1B annual sales potential.- Established connections with external experts, key opinion leaders (KOLs), and patient advocacy groups.

Specialized in early proof-of-concept and proof-of-mechanism read-outs. Developed clinical biomarker strategies for various diseases, with a focus on Cystic Fibrosis.- Designed translational medicine studies and managed biomarker assay and technology developments.- Contributed to IND and NDA filings.- Presented study results at international meetings.

Worked on clinical programs related to obesity, and wakefulness. Responsibilities include writing and reviewing clinical regulatory documents, designing study protocols, reviewing and co-authoring clinical study reports, writing manuscripts and reviewing and reconciling blinded data prior to database locks. Authored and co-authored clinical efficacy and pharmacokinetic documents for the recent Lorcaserin NDA submission.

Co-investigator for clinical research studies in the Department of Pediatric Gastroenterology and Nutrition- Designed research protocols for pre-clinical and clinical studies. Studies included a preclinical in vivo pharmacokinetics trial, phase 4 intestinal drug absorption study, and design and testing of a controlled-release preparation.- Assist with IND submissions to the FDA - Obtained and maintained IRB approvals- Recruited and enrolled study subjects- Analyze blood samples, primarily using tandem MS