Summary
Overview
Work History
Education
Skills
Languages
Certification
Education
Timeline
Generic

John Chibgwe MD, MBA, MPA

Łódź, łódzkie

Summary

A medical doctor with considerable years of pharmaceutical industry experience in areas such as clinical operations, patient safety, clinical/drug development and L&D, with profound knowledge in clinical medicine, system validation and UAT implementation, pharmacovigilance process and oncology clinical development.

I am a resolute, industrious, effectual and assiduous person. My ambition to be the best me is my main drive and it is fueled by the passion I have for the work I dedicate myself to.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Associate Director - Clinical Information Science

AstraZeneca
07.2024 - Current
  • Late Oncology Development
  • Primary Drug projects are Enhertu and Imfinzi. Provide support to colleagues and junior team member responsible for other products in early and late oncology as well as hematology.
  • Information Practice IEMT Lead and core member for the whole Enhertu portfolio in collaboration with Daichii Sankyo, Destiny Breast -11 and the whole Durva GU portfolio (IMFINZI) (IEMT- Information Exploratory Management Team. Its purpose is Managing additional statistical and programming analyses & reporting requests not pre-specified in the SAP/CSR)
  • Extraction of key clinical data from a variety of information sources required to make decisions on specific AZ product development by conducting extensive literature searches, review and creating powerpoint presentation and detailed excel sheet . Both in late and early oncology as well as Hematology
  • Lead the calculation of the Probability Of Technical Success needed to assess if a trial will move to the next phase or not.
  • IP Biometrics representative in conducting an sBR with patient safety representatives for a given AZ product within late oncology.
  • Collaborating with teams within oncology development to support submissions, inspection readiness as well as building abstracts to be used at conferences.
  • Advanced use of NLP software for literature searches as well as Machine Learning.

Patient Safety L&D and PV Process Manager

AstraZeneca
05.2023 - 06.2024
  • Brought in Harvard Medical School to be an L&D vendor to AstraZeneca Global Patient Safety and succefully launched the first training trials for Patient Safety members.
  • Assisted in the building, launching and continuous development of the AstraZeneca Global Patient Safety Academy, ensuring the trainings were relevant to and covered all aspects pf pharmacovigilance for all PV groups, including scientists and phycisians.
  • Supported tasks related to management of AstraZeneca training and Pharmacovigilance processes including implementation, communication, quality, compliance, tracking, performance and inspection readiness.
  • Supported the delivery of agreed learning and capability related activities according to priorities set by L&D strategy team, and the Associate Director L&D.
  • Worked closely with the Associate Director L&D and SMEs and processes leads across the organisation, taking responsibility for the management of assigned projects such as executing the delivery and technical support to L&D communication events and managing content platforms, technology resources and communication with the learners and stakeholders.
  • Provided PS Process owners with guidance, advice and support on PD process and promoting a culture of continuous improvement, high performance, flexibility and quality emphasising a “can do” attitude and innovative approaches.
  • Coordinated delivery of training and development in partnership with the accountable business and process owners, providing technical support to execution.
  • Supported development and implementation of training solutions which enhance organizational capabilities.
  • Supported the annual process for assessing Capability and Learning & Development needs.
  • Supported line managers in the effective training of staff.
  • Assisted with the collection and analysis of training evaluation metrics to support continuous improvement.
  • Supported development of training communications to the appropriate stakeholders.
  • · Provided technical and scheduling support to Process Owners and subject matter experts in delivery of effective Process awareness or training sessions.
  • Worked with vendors to facilitate the smooth delivery of learning initiatives.
  • Collaborated with PV Process Manager, Associate Director and Senior Director to support the enhancement of existing processes.

Specialist, Global Clinical Solutions-IRT Lead

AstraZeneca
02.2022 - 04.2024
  • Conducted R&D activities and delivered GCS services in the continuous management and maintenance of the IRT system in the clinical operations process.
  • Served as primary point of contact for 5 studies (3 in Late Phase Oncology & 2 in Biopharma) in all matters IRT.
  • Performed various UATs and system enhancements, and participated in drafting and authoring several regulatory documents, whilst also keeping the studies inspection-ready.
  • Designed a new training for the department that touches mainly on mechanism of drug actions & specific of treated diseases for the studies supported by the IRT Leads.
  • Capturing of lessons learnt in smartsheet for every IRT system update/enhancement/set-up in every AZ-IRT-supported study for future use when similar issues or problems are encountered in the respective activities.
  • Set up and maintained systems and data associated with Clinical Operations enabling services in partnership with Study Teams and external partners to appropriate standards, completeness, quality, and consistency.
  • Supported life cycle management and business continuity for Clinical Operations processes, systems/tools, standards, assisting in procedural documentation drafting and delivery of IRT training materials to system users.
  • Conducted relevant process/system/tool training facilitating knowledge sharing establishing of best practice ensuring communication within Clinical Operations.
  • Performed validation and testing of processes and systems.
  • Performed analyses of Clinical Operations processes and tools to define business usage and identifying opportunities to improve efficiency and effectiveness of systems/methods/processes.
  • Contributed to business cases for continuous improvement project.
  • Participated in change initiatives relating to Clinical Operations.

Education

MD - Medicine

Medical University of Lodz
2021

MBA - Business

Spoleczna Akademia Nauk
2021

MPA - Public Administration

Clark University
2021

Certificate - Drug Discovery & Development

Harvard Medical School
2023

Professional Diploma - Obstretics And Gynecology

Royal College Of Physicians in Ireland
Ireland
10-2025

Skills

  • Budgeting and financial analysis
  • Client relationship management
  • Change management
  • Decision making
  • Regulatory compliance
  • Project Management
  • Business intelligence tools
  • Negotiation
  • Regulatory requirements understanding
  • CRM software proficiency
  • Business acumen
  • Oncology Clinical Development
  • Patient Care
  • Clinical Medicine
  • Obstretics and Gynecology

Languages

English
First Language
Polish
Elementary
A2

Certification

  • Lekarski Egzamin Końcowy/ Polish Medical State Exam Certificate
  • Occupational English Test For Phycisians
  • Applied Project Management Certificate
  • Influencing Mastersclass Certificate

Education

other,other,other,other

Timeline

Associate Director - Clinical Information Science

AstraZeneca
07.2024 - Current

Patient Safety L&D and PV Process Manager

AstraZeneca
05.2023 - 06.2024

Specialist, Global Clinical Solutions-IRT Lead

AstraZeneca
02.2022 - 04.2024

MBA - Business

Spoleczna Akademia Nauk

MPA - Public Administration

Clark University

Certificate - Drug Discovery & Development

Harvard Medical School

MD - Medicine

Medical University of Lodz

Professional Diploma - Obstretics And Gynecology

Royal College Of Physicians in Ireland

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John Chibgwe MD, MBA, MPA