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.
Shown below are the latest jobs from this category.
Human Resource Manager
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Job Order: GD-715
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Job Description: Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for rare disease indications which adhere to US regulatory and company guidelines. Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and...
Central Florida, San Francisco, New Orleans,Arkansas
Job Order: GD-726
Job Description: Drive the success and growth of your sales region by generating leads vigorously and effectively. Meet with prospective and existing customers to provide product demonstrations and close on all product confidently. Cultivate early customer relationships for all company products. Participate in 3-5 weekly phone calls with Regional Sales Manager, RSM, (call objectives clearly...
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