Chief Scientific Manager

Department Details Role Summary 1 CRU Head BE Study monitoring IMP management CRO Qualification Evaluation of CRO for execution of Clinical studies Preparation of Protocol Synopsis Review and finalization of study protocol and report Preparation of Controlled Correspondence scientific advice SEC Meeting and Executive Summary for Regulatory submission Regulatory query response Clinical Non-Clinical Overview preparation Preparation of Clinical Documents Related to Devices Preparation of Executive summaries Controlled correspondence Scientific advice executive summaries for Regulatory submissions Result evaluation Establishing IVIVC models from In-Vitro In-Vivodata BE Prediction of new Test formulation evaluation and selection for batch for subsequent BE study To evaluate the critical PK aspects and discuss the same with FnD to improve biostudy success rate New product evaluation and Budget estimation Supporting dossier submission for extended markets Coordination with internal team CRO and other vendors for timely execution and submission of BE Maintenance of Project Tracker for BE Studies Departmental Training Coordinator Bio study execution at CROs within Budget Coordinate with Finance and legal team for CDA MSA Project Contracts with Vendors CROs Over all InCharge of clinical research unit and its related operations 2 CRU Clinical Operation BE Study monitoring IMP management CRO Qualification Evaluation of CRO for execution of Clinical studies 3 CRU Program Management New product evaluation and Budget estimation Supporting dossier submission for extended markets Coordination with internal team CRO and other vendors for timely execution and submission of BE Maintenance of Project Tracker for BE Studieso Departmental Training Coordinator Bio study execution at CROs within Budget Coordinate with Finance and legal team for CDA MSA Project Contracts with Vendors CROs 4 CRU Medical Writing Review Preparation of Protocol Synopsis Review and finalization of study protocol and report Preparation of Controlled Correspondence scientific advice SEC Meeting and Executive Summary for Regulatory submission Regulatory query response Clinical Non-Clinical Overview preparation Preparation of Clinical Documents Related to Devices Preparation of Executive summaries Controlled correspondence Scientific advice executive summaries for Regulatory submissions 5 CRU Clinical Operation BE Study monitoring IMP management CRO Qualification Evaluation of CRO for execution of Clinical studies Key Responsibilities 1 Chief Scientific Manager Biocon Pharma Limited Bangalore Key Responsibilities Planning coordination and execution of biostudies for different Regulatory Markets Contribute as member of Clinical development leadership team to continuous harmonization process improvement initiatives Knowledge sharing and setting the excellence framework for Clinical Research Conducting Preclinical PK and toxicity studies Clinical Strategy and Scientific Advice to support development of Generic and Complex Generic Product Support Formulation R D for Study Design Bio strategy Data Interpretation and in -vitro-in-vivo correlation using simulation software Review and provide inputs of Clinical documents Protocol Synopsis Study Protocol ICF Clinical study Report Study Monitoring and Audit of Clinical Research Organization to ensure quality and Regulatory compliance Provide scientifically rational responses to bio-deficiency received from Drug Regulatory Authorities Portfolio Evaluation Clinical due diligence Budgetary requirement Educational Qualifications Required Education Qualification Ph D Required Experience 10 - 20 years