Lead Safety Physician – Immune-oncology, Global Medicines Devlopment - Gaithersburg, MD | Biospace
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Lead Safety Physician – Immune-oncology, Global Medicines Devlopment

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
12/5/2016
Position Type:
Full time
Job Code:
R-001447
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

                             
                                       Location:Gaithersburg, United States
Cambridge, United Kingdom
Job reference: R-001447
Posted date: Nov. 28, 2016


 

   AstraZeneca’s vision inOncology
is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020.  A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. These are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.  

   As lead safety physician – Immuno-oncology development (Senior Director Physician) you’ll play a pivotal role managing safety input into global or regional studies within the Immuno-Oncology franchise.  Acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of safety data across disease areas and trial programmes.   

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.  

   We are developing a highly regarded comprehensive Immuno-Oncology portfolio, harnessing the power of the patient’s own immune system to fight cancer. These innovative therapeutic approaches, and others which we are spearheading, have the potential to revolutionize how cancer is treated.  

   Main Duties and Responsibilities
 

   You will take ownership of the patient safety risk assessment for the assigned trials/product(s), 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 will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field. Contributing to strategy and plans to optimize the safety profile of immuno-oncology drugs in development.  

   Core Responsibilities include:  

 
       
  •      Serve as a trial level physician to support the design, implementation and interpretation of clinical studies   with a focus and expertise on PatientSafety/Pharmacovigilence.
    Have responsibility for protecting the patient safety, integrity and conduct of clinical studies.    
  •    
  •      Partners with function Study Physician and cross functional stakeholders including PatientSafety/Pharmacovigilence
    and Global Medical Affairs. To develop and implement a strategy and plans to optimize the safety management of relevant TA compounds/drugs.    
  •    
  •      Establish and work with study physicians and clinical scientists in the development of clinical program patient safety related documents including informed consent forms and safety reports    
  •    
  •      Defines strategies or leads AstraZeneca’s response to complex technical issues for specific safety aspects in relation to current projects, new projects and various plans within the scope of the IO global medicines development unit (IO GMed).    
  •    
  •      Provides expert advice in the area of specialism, influencing the development of statistical analysis related to patient safety, to the global business and the Immuno-oncology TA.    
  •    
  •      Liaises with the internal and external medical community to follow developments within areas of expertise.    
  •    
  •      Establish and work with study physicians and clinical scientists to ensure appropriate standards for patient safety monitoring within Immuno-oncology study team.    
  •    
  •      Contributes to or manages the development of the senior management team in area of expertise    
  •    
  •      Maintain up to date awareness of all important advances within a given disease area through review of scientific literature, attendance at critical meetings and relationships with key external experts.    
  •    
  •      Within assigned areas disseminates new information within the Immuno-oncology TA to transform trends and emerging data into new plan    
  •    
  •      Contributes to regulatory communication and preparation of higher level documents.    
  •    
  •      Key Liaison for Immuno-oncology GMed to relevant AZ Science Units (MedI, iMed and GMD functions such as Patient Safety/PV)    
  •    
  •      Uses expertise and knowledge of global safety issues to support development of strategic objectives for inclusion into AstraZeneca’s annual business objectives    
  •  

   Requirements:  

   Essential:  

 
       
  •      Degree in medicine and experience as a physician or academic    
  •    
  •      Extensive experience in designing, monitoring and implementing clinical trials and interpreting trial results    
  •    
  •      Therapeutic area expertise and commercial understanding    
  •    
  •      Thorough understanding of pharmaceutical safety, reporting and surveillance processes, extensive 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    
  •    
  •      Proven leader of cross-functional delivery teams. Project Management Competent level.    
  •    
  •      Professional at innovation, integrating experts; co-ordinate PSDA discussions into Enabling Safety Science priority setting.    
  •    
  •      Professional in PS/PV capability including having significantly contributed to safety components of regulatory submissions and PRMP production    
  •    
  •      Experience of benefit:risk evaluations    
  •  

   Desirable:  

 
       
  •      Extensive general medical oncology knowledge    
  •    
  •      Able to work across TAs and Functions    
  •    
  •      Research background including peer reviewed publications    
  •    
  •      Significant experience in advanced research and development    
  •  

   At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.  

   If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person– Apply today!

   This role offer a highly competitive salary and benefits package.  

   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.
 

~bsp

Requirements

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