Medical Affairs Manager

Company Name:
Therapy area
Infection - antibiotic clinical development
Description -
Medical Scientist resource to support phase 3 programme for Cetazidime-avibactam (CAZ-AVI) a novel -lactam- -lactamse inhibitor combination in phase 3 development for the treatment of antibiotic resistant hospital infections
. Specific activities include the following:
Medical science oversight, with physician, of CRO-led cUTI study.
In particular; support for end of study procedures including table and listings, blind data review, patient/case evaluability reviews.
Co-ordination of medical science support and integration with operations and CRO activities
Support for submission planning where appropriate
Support for medical review of data for ongoing global phase III and asia studies
Time commitment
US, site and home based, supporting teams based in UK,US and Asia
Key Skills / experience required
Experience in phase III medical monitoring, end of study procedures. Pharm D, Ph.D, BSc (with experience). Antibacterial infectious diseases (ID) experience an advantage ..
Key capabilities & behaviours required
Hands on attitude. Flexible approach to working. Strong medical science credibility with a delivery focus. The ability to work smartly across a busy programme with the communication skills and engagement required to be successful in a lean and agile global team.
Min Salary: $0.00
Max Salary: $0.00
City: Gaithersburg
State: MD

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