Safety Medical Director – Respiratory, Inflammation, Autoimmune, Infection and Vaccines (RIAIV) - Gaithersburg, MD | Biospace
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Safety Medical Director – Respiratory, Inflammation, Autoimmune, Infection and Vaccines (RIAIV)

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
12/6/2016
Position Type:
Full time
Job Code:
R-000384
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Gothenburg, Sweden
Job reference: R-000384
Posted date: Oct. 28, 2016


 

   At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Safety Medical Director in our Global Patient Safety organization, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.  

   AstraZeneca holds a unique position in respiratory disease, including asthma, chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF), with a range of differentiated potential medicines in development by leveraging novel combinations, biologics and devices. The pipeline also has a number of promising assets in inflammatory and autoimmune diseases within areas such as psoriasis, psoriatic arthritis, gout, systemic lupus and rheumatoid arthritis.  

   Main Duties and Responsibilities  

   As a Safety Medical Director, you will be responsible for managing safety input into global or regional therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of  safety data across disease areas and trial programme.  You will take ownership of the patient safety risk assessment for the assigned products, strategically as well as for emerging safety information. You will bring deep clinical understanding and judgment to the patient safety risk perspective in benefit risk assessments. You’ll insure projects adhere to Good Clinical and Pharmacovigilance Practice and regulatory requirements. You will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field.  

Requirements

   Essential Requirements  

 
       
  •      Degree in medicine and experience as a physician or academic    
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  •      Extensive experience in designing, monitoring and implementing clinical trials and interpreting trial results    
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  •      Significant experience in advanced research and development    
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  •      Therapeutic area expertise and commercial understanding    
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  •      Thorough understanding of pharmaceutical safety, reporting and surveillance processes and >5 years’ experience of Patient Safety as it relates to clinical trials and marketed products in any relevant field such as pharma, Regulatory Agency or Public Health agency    
  •    
  •      Understanding of the medico-legal aspects of pharmacovigilance    
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  •      Proven leader of cross-functional delivery teams. Project Management Competent level.    
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  •      Able to influence others within the RIAIV therapeutic area    
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  •      Professional at innovation, integrating experts; co-ordinate PSDA discussions into Enabling Safety Science priority setting.    
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  •      Professional in Patient Safety/Pharmacovigilance capability including having significantly contributed to safety parts of regulatory submissions and PRMP production    
  •    
  •      Experience in benefit: risk evaluations    
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   Desirable Requirements  

       
  •      PhD in scientific discipline    
  •    
  •      Extensive general medical knowledge    
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  •      Able to work across TAs and Functions    
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  •      Research background including peer reviewed publications    
  •  

   Next Steps – Apply today!  

   To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.  

   AstraZeneca is an equal opportunity employer.  AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.  

   ~bsp