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Job Information
Job Order ID : MD0063962# of Positions : 1Minimum Education Level : Doctoral DegreeExperience Required : noneDuration : Full Time RegularShift : First Shift (Day)Hours per week: 40
Job Description
 Overview To provide medical support to the clinical development team based in the US and to liaise with the clinical team based in the UK. The role will be at a strategic level for the development of clinical plans to efficiently develop vaccine products and therapeutic biologics in the Emergent pipeline. On a day to day basis the operational role will be directed to ensuring the safe and efficient resolution of medical matters arising from clinical trials. Key responsibilities 1. Support the concept, strategy, design and planning of clinical trials for the EPDG pipeline of development products. 2. Provide medical input into all project teams to enable the delivery of overall project objectives. 3. Provide clinical/medical education to the clinical team in current and new therapeutic areas as required. 4. Maintain an awareness of current thoughts on best clinical practice in the therapeutic areas of interest. 5. Provide reviews of Serious Adverse Events occurring in clinical trials and to take responsibility for clinical safety in clinical trials. 6. To assist Clinical Operations in the setup of Data Safety Monitoring Boards and Data Review Committees, acting as the primary contact, providing the key safety data for review and ensuring medical reviews of data are conducted in an appropriate time frame. 7. Have signatory responsibility for investigators brochures, study protocols, clinical study reports and other documents. 8. Provide clinical advice to regulatory affairs and assist in the compilation of clinical documents in regulatory submissions, and to serve as the medical expert for interactions with regulatory authorities. 9. Liaison with medical organisations and opinion leaders in the therapeutic areas of interest. 10. Work with clinical operations team to assist in the selection of external vendors if necessary. 11. Work with business development team to conduct clinical/medical diligence activities for new business opportunities and support grant/contract writing activities to secure government and NGO funding. Experience/Training • Vaccine experience gained in the Biotech environment is essential. • Experience in liaison with government agencies is desired. • Current and active medical license in the United States. • At least 5 years of experience in clinical development in an industry setting. • Board certification in any clinical discipline is a plus. 
Company Information
Name : Emergent Biosolutions
Application Information
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