Santa Clara, California, United States
Clinical research professional with extensive experience leading clinical trial operations and protocol development for rare disease therapeutics. Managed 20+ clinical trials across drug, gene therapy, antibody, cell therapy, and medical device programs spanning Phase I–III and open-label extension studies in both adult and pediatric populations. Experienced in clinical protocol development, IND regulatory submissions, IRB management, safety review, and clinical data analysis. Proven ability to collaborate across clinical development, regulatory, data management, and translational research teams to successfully execute complex clinical programs. Contributed to development of VYJUVEK, the first FDA-approved gene therapy for recessive dystrophic epidermolysis bullosa (RDEB). Contributed to research initiatives that secured $1.8M in funding support. CORE COMPETENCIES: Clinical Development Strategy, Clinical Trial Operations (Phase I–III), Protocol & Amendment Development, IND & Regulatory Submissions, IRB (Local & Central) Management, Rare Disease Clinical Research, Gene Therapy & Cell Therapy Trials, Medical Monitoring Support, Clinical Data Review & Analysis, EDC Setup & Source Documentation, Cross-functional Team Leadership. GCP / FDA Compliance
Lead clinical research operations and protocol development for multiple rare disease and squamous cell carcinoma clinical programs involving gene therapy, biologics, and cell-based therapies. Key Contributions • Provide strategic input to clinical development plans and study design for rare dermatology therapeutic programs. • Lead preparation and revision of clinical study protocols, protocol amendments, and informed consent documents in collaboration with clinical leadership. • Support development of regulatory documentation including IND submissions, IRB protocols, and investigator materials. • Assist in medical monitoring activities, including review of subject enrollment packets, adverse events (AE/SAE), and clinical safety data. • Manage execution of Phase I–III and open-label extension clinical trials involving adult and pediatric populations. • Collaborate with Data Management teams to ensure timely and accurate capture of clinical data and assist in review and cleaning of clinical data listings. • Establish EDC systems and source documentation frameworks to ensure regulatory-compliant data capture. • Maintain clinical study documentation and secure trial master files. • Coordinate activities of research staff including clinical coordinators, regulatory specialists, and laboratory personnel. • Contributed to research initiatives that secured $1.8M in funding support. Clinical Programs Supported: VYJUVEK – first FDA-approved gene therapy for RDEB, Dabocemagene Autoficel, Efgartigimod. CAART Therapy
• Coordinated clinical studies supporting translational medicine initiatives. • Managed patient recruitment, regulatory documentation, clinical data collection, and study coordination. Clinical Programs Supported: OTO-201, OTO-104, Lacrimal Stent. Azficel-T
Responsible for doing in vitro clonogenic assays on drugs in phase I and II of clinical trials in the MDS clinic at Stanford. Drugs studied included VEGF, Farnesyl Transerase Inhibitors, Darbepoietin Alpha. Actively involved in nano-immunoassays with Rigosertib and Anti EphA3 Monoclonal Antibody. Solely responsible for gene expression studies using microarray. Was actively involved in the investigating Gene Expression using RNA seq from the stem cells isolated from patient samples and Proteomic study for biomarker discovery using the plasma from Myelodysplastic Syndrome (MDS) and Normal subjects. Manage tissue bank including procurement, processing and banking plasma, mononuclear cells and stem cells from MDS patients and Normal subjects. Managing and training students (undergraduate and graduate), in all facets of study related procedures, compliance with respect to HIPAA and laboratory safety