Samit Joshi's Email Addresses & Phone Numbers

Medical Director @ ViiV Healthcare As Physician Product Lead (Clinical Lead) within Clinical Development, I am responsible for providing the clinical leadership of an anti-infective drug in Phase 2a clinical development. Greater New York City AreaAssistant Clinical Professor @ Yale School of Medicine -In/Out-Patient care (Infectious Diseases)-Bedside and didactic teaching for students, interns, residents, and fellows. Clinical...

Medical Director @ ViiV Healthcare As Physician Product Lead (Clinical Lead) within Clinical Development, I am responsible for providing the clinical leadership of an anti-infective drug in Phase 2a clinical development. Greater New York City AreaAssistant Clinical Professor @ Yale School of Medicine -In/Out-Patient care (Infectious Diseases)-Bedside and didactic teaching for students, interns, residents, and fellows. Clinical Instructor @ Yale School of Medicine -In/Out-Patient care (Infectious Diseases)-Bedside and didactic teaching for students, interns, residents, and fellows. From May 2012 to June 2016 (4 years 2 months) Fellow (Infectious Diseases) @ Yale School of Medicine -Clinical and bench training in Infectious Diseases. -Area of study: Innate immunoscencence and oral microbiome-Mentor: Albert Shaw M.D., Ph.D. From July 2008 to May 2012 (3 years 11 months) Resident (Internal Medicine) @ Yale School of Medicine From July 2005 to June 2008 (3 years) Medical Director @ Bristol-Myers Squibb Responsibilities as Study Director/Medical Monitor and Therapeutic Area Medical Lead within Global Clinical Research and Exploratory Clinical & Translational Research across four different anti-infective targets, from Phase 1-3:Regulatory Interactions:• FDA EOP 1 & 2 meetings• Breakthrough Therapy Designation• Dose selection rationale and Background/Briefing documents• Trial amendments or responses to FDA and HAs internationally.• Harmonization of HA FeedbackI have demonstrated both matrix leadership and cross-functional collaboration:• Led multidisciplinary study teams• Balanced high quality decision-making against speed & risk• Focused on the most important workLeadership in Clinical Trials:• Leading clinical trial conceptualization, design, execution, ongoing in-depth real-time clinical monitoring, long-term follow-up, & termination • Leading data analysis, synthesis, & presentation • Leading Phase 1-3 dose(s) selection• Leading clinical and scientific interactions with EU/US CROCore Global Clinical Research Activities:• Clinical and scientific contribution to medical strategy for Phase 2b and 3 assets • Country and site selection• Built close relationships with EU/US KOLs at advisory boards & PIs at conferences and investigator meetings • Developed clinical documents: synopses, protocols, IBs, ICFs, DSURs, and CSRs• Pediatric program conception, design, and submission• Due diligence/Business Development with both CRO & Biopharma companies• Expertise with Internal process improvementTranslational R&D physician • Animal model for study anti-infective drug safety & efficacy.• Evaluation of laboratory assays predicting observed clinical responses• Characterization of clinical anti-retroviral safety, efficacy, & resistance• Immunology and Epidemiology of HIV-1 infected populationClinical Trials: • Phase 1/2 Study of anti-infective agent• Phase 2b Study: NCT02415595• Phase 2b Study: NCT02386098• Phase 3 Study: NCT02362503 From February 2014 to July 2016 (2 years 6 months) Wallingford, CTAssociate Medical Director @ Bristol-Myers Squibb Responsibilities as Medical Monitor across two different anti-infective targets:• Ongoing in-depth real-time monitoring of safety, tolerability, efficacy, and resistance• Provided clinical expertise in the termination of Phase 2b trial AI467-003• Evaluation of clinical assays used in trials• Phase 3 protocol planning, development, and writing• Data analysis, synthesis, and presentation (Internal and DSMB)Clinical Trials: • Phase 2b Study of BMS-986001 (HIV-1 Nucleoside Reverse Transcriptase Inhibitor): NCT01489046 • Phase 2b Study of BMS-663068 (HIV-1 Attachment Inhibitor): NCT01384734 From May 2012 to February 2014 (1 year 10 months) Consultant (Infectious Diseases) @ Waterbury Hospital -Consultative coverage for the Infectious Diseases Service-Engaged in intern and resident education (bedside and didactic) From August 2010 to May 2019 (8 years 10 months)