Abdul Mehbob Email and Phone Number

Senior Scientist working in the Pharmacovigilance Evaluation and Reporting Group.

Associate Principal Scientist within the Early Development Team.

Position: Clinical Scientist Associate*Lead Scientist and Study Management Team member for Ocrelizumab Phase III global clinical trials and then rituximab Phase II/III global clinical trials and Phase IV PMC trials.*Lead responsible for new protocols and amendments/ICF writing and implementation, CRF design, SMT data review plans, database lock activities, analysis of interim and final study outputs (efficacy and safety data), long term safety data pooled annual analysis… Show more Position: Clinical Scientist Associate*Lead Scientist and Study Management Team member for Ocrelizumab Phase III global clinical trials and then rituximab Phase II/III global clinical trials and Phase IV PMC trials.*Lead responsible for new protocols and amendments/ICF writing and implementation, CRF design, SMT data review plans, database lock activities, analysis of interim and final study outputs (efficacy and safety data), long term safety data pooled annual analysis, ongoing review/signal detection for clinical trials (individual patient data and overall grouped data summaries). *Reviewer/author for clinical trial related documentation including but not limited to statistical documents (DAP/LoPO), informed consent forms, protocols, clinical study reports, Investigator brochure, drug safety/development reports (DSR/DSUR/PSUR/RMP/PBRER) and investigator/health care professional communications (DILs/HCPs) and response to Heath Authority/Ethic Committees Clinical Study/Protocol questions. *Lead scientist for multiple CSRs’ data compilation/document preparation (lead author) and submission. *Lead responsible for annual safety review, SAE reconciliation and SAE narratives across the global development program for CSRs and primary reviewer for clinical trial SAE reports to sponsor. *Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations.Previous position: Drug Safety Specialist (Pharmacovigilance Group) *Lead responsible for overseeing individual case safety reports (ICSR) from Roche sponsored clinical trials and PMPs to external HAs and BPs*Safety contact for health authorities, global affiliates, internal functions and business partners. *ICH E2B ICSR subject matter expert for business projects. *Reviewer/author of group GCP SOP documentation. Show less

Position: Cell Biologist (Metabolic & Virology Centre of Excellence for Disease Discovery)*Preclinical scientist responsible for using cell based signalling systems to test novel compounds for efficacy and toxicity (safety). *Compounds targeted towards hepatitis C RNA dependant RNA polymerase (HCV NS5B) with the aim of identifying a molecule with replicon antiviral activity; and the toll like receptor 7 (TLR) with the aim of specifically inducing a TLR7 antiviral response… Show more Position: Cell Biologist (Metabolic & Virology Centre of Excellence for Disease Discovery)*Preclinical scientist responsible for using cell based signalling systems to test novel compounds for efficacy and toxicity (safety). *Compounds targeted towards hepatitis C RNA dependant RNA polymerase (HCV NS5B) with the aim of identifying a molecule with replicon antiviral activity; and the toll like receptor 7 (TLR) with the aim of specifically inducing a TLR7 antiviral response. *Safety and efficacy data used to drive a successful candidate selection process for first time in human (FTIH) clinical trials for several new molecular entities. *Large quantities of analysed data managed and communicated to functional program teams effectively and efficiently without compromising data integrity and timelines. *Supervisor responsible for managing industrial placement students/contractors (part of company initiative to identify and provide training to employees with potential for management). *Laboratory supervisor responsible for maintaining and ensuring the GLP standards and everyday operation of the cell biology labs. Previous Position at GSK: Development Research Assistant (2002 – 2004) *Designing and developing innovative structure activity relationship (SAR) assay systems for use by research scientists within the high-throughput screening (HTS) research and development organisation. *Focus on developing a robust and reproducible SAR assay systems based on the effects of novel compounds specific to the androgen and progesterone nuclear receptors. Show less