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Senior Clinical Development Manager - Rixensart [02/03/2010] |
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Details:
GlaxoSmithKline Biologicals is one of the world's leading vaccine producer and the fastest growing business within the GSK group today. Headquartered in Rixensart & Wavre, Belgium, GSK Biologicals employs approximately 9,000 people worldwide, including over 6,000 in Belgium. GSK Biologicals’ global production network is in the midst of becoming the largest in the entire vaccines industry. 13 sites on three continents manufacture, formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.
Job Purpose
GSK Bio is developing a vaccine candidate against Mycobacterium tuberculosis in collaboration with several international partners. The M72/AS01 candidate tuberculosis vaccine has been evaluated in Phase I-II clinical trials in TB naïve adult populations in Belgium, US, Switerland and S. Africa. The vaccine has also been evaluated HIV Swiss volunteers and inTB-exposed adult populations from The Philippines and South Africa. Future clinical development will focus on efficacy studies in the adolescents/adults and infants/children in endemic areas.
To drive this project forward we are seeking a Senior Clinical Development Manager, Tuberculosis. The position is based in Brussels (Rixensart) and requires frequent overseas travel.
Reporting to the Lead Clinical Development Manager (CDM) this individual will take operational responsibility for the Tuberculosis vaccine clinical trials to ensure high quality of study conduct and timely delivery of all clinical data in compliance with the clinical development plan, good clinical practices (GCP), and GSK Biologicals standard operating procedures (SOP).
Responsibilities
-Implementation of a clinical development plan
-Management of external collaborations
-Management of study budget, resources and timings in collaboration with the clinical project manager
-Regular scientific progress reports to the Project team
-Representation of the project in internal and external meetings
-Medical monitoring of Phase II-III clinical trials
-Development of the clinical part of the files and its registration process in collaboration with the Project team
-Active follow-up of the project related environment Basic qualifications:
-Degree in Medicine
-Postgraduate experience in clinical tropical medicine (asset)
-Excellent written and spoken English, additional languages (e.g. French) are an asset
Preferred experience
-Medical Doctor with experience in clinical research with good knowledge of GCP and regulations governing clinical research
-Previous documented research experience (basic or applied research)
-A good knowledge of immunology is an asset
-TB specialist – understands the epidemiology of TB, has worked with TB patients
-Operational knowledge and understanding of statistical applications
-Tropical pediatric or adult medicine experience
The successful candidate will also possess
-Solid understanding of scientific methodology in the design, conduct and interpretation of clinical research
-Proven organizational and managerial skills
-Excellent communication and presentation skills
-Ability to work within a matrix environment to deliver clinical objectives on time
-Leadership skills to develop the full potential of internal and external teams
-Computer literacy
Job Type:
Permanent
Location:
Bangladesh
Salary:
[n/a]
Date available:
now
Experience Skills:
Professional
Company:
Glaxo Smith Kline
Company Description:
[n/a]
Company Website:
[n/a]
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08/12/2009