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
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