Dr. Jayanth GS, MD

Experience

• 

  Apollo Hospitals

  Feb 2011 - Nov 2011

  Clinical pharmacologist and Clinical research site coordinator

  Auditing all the medication prescriptions for scientific rationality across the critical departments (MICU, NICU and SICU) with- Drugs substitution and dose titration as per clinical requirements - Monitoring medication errors - Adverse drug reaction (ADR) monitoring • Convener for Drugs and Therapeutic Committee • Member of Infectious Disease Control Committee • Lead the team of pharmacy for Joint Commission International (JCI) accreditation audit• Clinical trial site coordinator Show less

• 

  IQVIA

  Dec 2011 - Jul 2014

  Associate Manager, Pharmacovigilance Physician

  • As a primary safety physician, reviewed safety data of Individual case safety reports• Safety signal detection, safety assessments and regulatory submissions• Periodic review of non-serious line listings for reassessment on seriousness of event• Reviewed the aggregate reports (PADER document) for regulatory submission• Periodically reviewed and updated product labelings (SmPC and USPI)• Supported the team lead in resource and work allocation• Guided safety associates in triaging the ICSRs for seriousness, Causality assessment and case creation, MedDRA coding, labeling/ expectedness. Show less

• 

  Syngene International Limited

  Aug 2014 - Apr 2019

  Clinical Development_Oncology& Vaccine_ Project Physician

  Clinical development activities of Early and Late phase clinical trials for Oncology, Immunology, Rheumatology products, Vaccines, Infectious Diseases and Nutraceutical product.• Authored IMP dossier, IB with FIH dose selection for NCE molecules• As a Medical advisor, supported CD planning, handled RFP and feasibility assessments• Medical monitoring of First in Human, Phase 1 to 3, epidemiology study and BABE studies• Medical writing of IB, protocol, ICF, study reports and safety narratives• Medical and safety monitoring plan and Risk management plan• Literature search for scientific evidence and data• Dossiers for regulatory submission and Scientific committee meeting presentations• Trained and certified MedDRA and WHO-DG coder• Periodic study data review and safety reporting to regulatory authorities• Protocol training to PM, CRA, DM and Stats team. And handled Investigator meetings• Reviewed statistical analysis plans, did TLFs analysis for study reports• Organized and presented data for DSMB /Interim analysis meetings• Managed a team of medical writers and DSA• Handled client audits and regulatory Inspections by FDA, EMEA, ANVISA and DCGI• Worked with cross-functional consulting teams (Business development, Regulatory, Bio-stats, Data management and Bio analytical team-PK) Show less

• 

  Aurigene Discovery Technologies

  May 2019 - Apr 2021

  Early Clinical Development_ Oncology/ Hematology_ Senior Manager

  Clinical development activities for Early phase of NCEs: CD Plans, Scientific inputs and support to pre-IND packages, Scientific Advisory board meetings, Feasibility assessment, Reg. Submissions and Clinical operations.• Medical Writing- IB, Protocol, Project plans, RMP, DSUR and Executive summaries• Literature search for scientific evidence and data• Preparation of Dossiers for IND application and Scientific committee meeting presentations• Coordinate with KOLs and conduct Scientific Advisory board meetings• Identify, evaluate and negotiate with service providers (DM, Stats, Lab services, etc.)• EC submissions and address scientific queries• Clinical trial sites and Investigator selection, and Study Initiation activities• Medical monitoring, patient safety data review and reporting• Review of Statistical analysis plans, TLs for programmed data and TLFs analysis for study reports• Working with cross-functional consulting teams (Product development, Reg, Biostats and PKPD)• Study milestones and Budget assessment• Execution of DSMB/Interim analysis meetings Show less

• 

  Sun Pharma Advanced Research Company Ltd.

  Apr 2021 - Feb 2022

  Clinical Development_ Oncology_ Deputy General Manager
• 

  ThermoFisher Scientific

  Mar 2022 - now

  Clinical Development_ Hematology/Oncology_Strategy Consulting

  As a Strategy consulting SME, provides support and consultation in all scientific aspects of full product development and programme level activities in Hematology/Oncology. Hands on experience in developing CGT, biosimilars, radiopharmaceuticals, vaccines and orphan drugs. Work on CDP/ IDP, designing clinical trials across all the phases by leveraging innovative trial designs (master protocols, bayesian adaptive, basket and umbrella trial designs). Regulatory submissions and interactions (INTERACT, Pre IND, IND, BTD and ODD). Hands on experience in leveraging the RWE and epidemiological data into strategic development and execution of clinical trials. Show less