Associate Director, Clinical Development - (Gaithersburg, MD) - Gaithersburg, MD | Biospace
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Associate Director, Clinical Development - (Gaithersburg, MD)

MedImmune, LLC

Gaithersburg, MD
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:

Job Description

                                       Location:Gaithersburg, United States
Job reference: R-001774

Posted date: Dec. 05, 2016


   If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions -- join us.  

   MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As an Associate Director, Clinical Development in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.  


   We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.  


   MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.  

   Major Duties and Responsibilities  

   As a well-trained clinician with strong leadership skills who is driven by science and the desire to develop novel ADC therapies for cancer patients, you will be responsible for medical monitoring of ongoing clinical trials, the planning and conduct of clinical trials. You will provide long-range clinical development planning, planning and managing of clinical research projects and clinical development programs with a focus on the ADC -- Hematology, collaborating with and providing clinical input and expertise to pre-clinical and translational sciences, and setting and achieving goals and meeting timelines in accordance with corporate goals and budgets.  

   You will serve as the project Medical Monitor while working in a cross functional environment with representatives from other involved line functions as well as Late-Stage Development. You will contribute to and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.  

   You will serve as medical monitor with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance. You will establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports. You will be responsible for assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in light of developments in the area of clinical and pharmaceutical oncology. You will collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products. Provide leadership on cross-functional product development team(s) as experience allows.    
   Participate in identification, selection and conduct of negotiations with clinical research centers and investigators. Participate in the selection and management activities of CROs. You will supervise project team members in planning, conducting and evaluating clinical trials. Oversee planning and management of investigator meetings, advisory boards and other scientific committees.  


   Essential Requirements  

  •      MD.    
  •      Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology.    
  •      Associate Director: At least one or more years of experience in clinical research and/or oncology drug development in an academic, pharmaceutical or CRO environment    
  •      Director: At least two or more years of experience in clinical research and/or oncology drug development in pharmaceutical or CRO environment    

   Desirable Requirements  

  •      Current medical license    
  •      Medical specialty and sub-specialty training and certification (or eligibility) are highly desirable in medical oncology and/or hematology.    
  •      Act independently with minimal supervision in many situations but may require moderate supervision on complex issues. Able to make most medical decisions with minimal consultation but will require moderate supervision on complex medical decisions.    
  •      ADC and Haematology development experience.    
  •      Experience in molecular oncology and/or translational science.    
  •      Special Skills/Abilities (for Associate Director and Director except where noted):    
  •      Excellent oral and written communication skills; strong interpersonal and listening skills    
  •      Results driven to achieve creative and sound outcomes    
  •      Clear understanding of the drug development process (especially early phase clinical trials), protocol writing and study conduct, data review and reconciliation, the principles of translational medicine, and lead team successfully.    
  •      Proven leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment.    
  •      Ability to make sound and timely decisions; agile in learning and action oriented    
  •      High level of emotional intelligence; able to deal with ambiguity    
  •      Able to relate to varied level audiences across the organization; able to build and lead effective teams; able to set priorities for team and maintain accountability; skillful in negotiating organizational boundaries and hierarchy; experience managing and developing others; (Director only)    

   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.