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Clinical Research Director - Multiple Myeloma

Vitry, France or Cambridge, MA,
Job Order: GD-717

 

Job Descriptions:

  • Establishes or adapts clinical development plans for the programs including discussions with clinical investigators, advisors and regulatory authorities and contingency planning.
  • Authors protocol extended synopses, clinical sections Investigator Brochure, clinical sections of IND/IMPD fillings, annual reports, development risk management plans. Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries, including regulatory submissions.
  • Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical trial program within a matrix environment
  • Presents and discusses development strategy and clinical study results with key internal stakeholders, external investigators and advisory boards, and regulatory authorities, as appropriate      
  • Author clinical abstracts, presentations for conferences, and manuscripts, when appropriate

 

Job Requirements:

  • MD degree or equivalent
  • Oncology and/or Hematology fellowship or significant experience (5+ years) in Oncology and/or Hematology, preferably with experience in myeloma or hematologic malignancies
  • Expertise in medicine, oncology and pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years), preferably with experience in early development
  • Demonstrated ability to interact productively with and attract top external investigators
  • Demonstrated ability to work with a multifunctional team to achieve project milestones
  • Understanding of and willingness to meet applicable regulatory, quality and compliance standards
  • Position will be based in Vitry, France or Cambridge, MA, USA or Bridgewater, NJ, USA

 

DATE POSTED 2019-10-24

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