Project Title

Janssen Pharmaceutica NV, Beerse, Belgium

EDCTP Project Call

EDCTP Clinical Research & Development Fellowship (R&D F)

Project Objectives

The main objective is to gain knowledge and practical expertise in many aspects in the set up and conduct of a clinical trial in SSA and to bring back the knowledge to the Home institution.

Study Design

12 months placement at Janssen, and 6 month reintegration at home institution.

Project Summary

The fellow will become member of a global clinical operational team to conduct clinical trials in the SSA region related to HIV/AIDS, Tuberculosis, Vaccines development (Ebola, HIV, Hepatitis C) or other neglected tropical diseases of relevance to the Janssen portfolio. He will be in charge of prefeasibility/ exploratory work: define feasibility and optimal study placement based on intelligence data, pro-actively identify investments to be made/gaps in terms of regulatory framework, capacity building (infrastructure/resources) and make proposals for operational readiness of investigational sites and countries. The fellow is expected to actively build relationships /network with local stakeholders (academia, NGOs, local CROs or other development partners) and regulatory bodies in various countries of SSA and build a framework for operational excellence. He will be involved in internal decision making related to portfolio decisions for placement of trials in certain countries and provide input related to CRO selection to support the trial. The fellow will also be involved in the set-up and execution of global trial(s) and gain expertise in the management of complex multi country trials with a cross-functional matrix trial management team. He will be exposed to various aspects of the trial from protocol design to clinical study reporting. In addition, he will be asked to inventorize current operational challenges in setting up global clinical trials in SSA across the Infectious Diseases and Vaccines Therapeutic Area, and create a plan detailing how these can be overcome and ensure operational readiness.

Host Organisation

Current Organisation

Current Job Title

Biography