Hematology / Oncology Medical Affairs Delivery Unit (MADU) Janssen Innovative Medicine, Pharmaceutical Companies of Johnson & Johnson, USA (Mandated by ICON, Plc)
● Protocol CLL2032: Phase II IS: Multicohort Study to Customize Ibrutinib (Imbruvica) Treatment Regimens for Patients with Previously Untreated Chronic Lymphocytic Leukemia

Hematology / Oncology Global Studies & Global Public Health Janssen, Pharmaceutical Companies of Johnson & Johnson, USA (Mandated by ICON, Plc)
● Protocol JNJ NAP4001: Phase IV Prospective, Observational NIS PASS Study: Post-authorization safety study to evaluate the incidence of and risk factors for severe and fatal Infusion related reactions in participants treated with Daratumumab (Darzalex®) Intravenous or subcutaneous in patients with Multiple Myeloma
● The Global Trial Leader provides global, regional or complex local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to-end program/ project management including start-up, execution, close-out, analysis and reporting. Further, services will ensure the teams operational activities are in line with country specific regulations and trial teams are delivering high quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical Program Leader (CPL), Clinical Operations Head (COH), Global Clinical Trial Assistant (GCTA MAO), and other Global Trial Leaders (GTL) to ensure overall study delivery at the country level.
Deliverables: Contribute as a ment

Trial Management, Global Drug Development Novartis Pharmaceuticals Corporation, Fort Worth, USA

Trial Management, Global Drug Development Novartis Pharmaceuticals Corporation, Alcon Fort Worth Campus, USA

Global Clinical Trial Leadership, Global Drug Development Novartis Pharmaceuticals Corporation, Alcon Fort Worth Campus, USA
● January 2017- January 2022: Approvals for Beovu from global HA - FDA, EMEA, TGA, Swiss Medic, Japan, Health Canada
• Phase III Novartis: HAWK Study- A Two-Year, Randomized, Double-Masked, Multicenter, Three- Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age Related Macular Degeneration
• Phase IIIb Novartis: TALON Study- A 64 week, two-arm, randomized, double-masked, multi- center, phase IIIb study assessing the efficacy and safety of brolucizumab 6 mg compared to aflibercept 2 mg in a treat to-control regimen in patients with Neovascular Age-Related Macular Degeneration
• Other Key Deliverables: DSMB, Investigator Meeting planning and presentations, planning events at congresses like AAO, ARVO
● - Digital Therapeutics Studies
• NoPHIS Protocol: Feasibility of Visual Acuity assessments using Focal View at home and in the clinic, including comparison with e-ETDRS assessment in the clinic, in subjects with nAMD or DME
• NIS: A non-interventional study based on HAWK and HARRIER clinical trials to evaluate the accuracy of the Intelligent precision dosing application (IPDA) in assessing disease activity in patients with nAMD treated with Brolucizumab
• A 52-week randomized, single masked, multicenter proof of concept study of binocular video games versus patching for amblyopia in children 4-7

The Global Lead Clinical Site Manager is responsible for supporting the implementation and execution of Alcon's clinical trials by performing specific project management tasks at country, regional and site levels;

Study Management

• Maintained a stably transfected CHO engineered cell line which over expressed Human Myocilin
• Purified the Myocilin using Size ExclusionChromatography
• The purified protein was contracted out to generate monoclonal antibodies & perform X-Ray Crystallography for protein structure elucidation
• Contributed to presentation of Glaucoma basic research results within Alcon R&D at peerlevels

• Cloned (in a bacterial system), optimized, quantified & purified human recombinant therapeutic cytokines
• Gamma Interferon, GMCSF & Epidermal Growth Factor
• Assisted the Clinical Research Group with the Clinical Product Launch materials for Syscan Eye Drops, Fluconazole Ophthalmic Solution 0.3%

• Developed Nested PCR-based Nucleic Acid diagnostic assay for studies to detect viruses causing ocular inflammation (collaboration with Yokohama School of Medicine, Japan as a part of the world wide epidemiology of infectious conjunctivitis detection
• Presented work in Ophthalmic Grand Rounds at the Institute, National (Indian Eye Research Group IERG) & International conferences (ARVO)