Collaborates with the Clinical Lead to establish or adapt clinical development plans for the project including discussions with clinical investigators, advisers and regulatory authorities and contingency planning.
Author protocol extended synopses, clinical sections Investigator Brochure, clinical sections of IND/IMPD fillings, annual reports, development risk management plans. Data interpretation, 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 multi-functional team to achieve project milestones.
Understanding of and willingness to meet applicable regulatory, quality and compliance standards.