FreshRemote.Work

Executive Medical Director, Hematology

Remote (US)

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Executive Medical Director will support BeiGene Clinical and Medical assets within the Hematology franchise by successful development of early and late phase clinical development strategies and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. The candidate will report to the Vice President of Clinical Development Hematology.   As a leader in the organization, the incumbent will be involved with clinical program strategy and help assure that activities are executed within expected scope, budget, and timelines. The incumbent will play a key role in the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Essential Functions of the job:

  • Protocol concepts, synopses, and amendments
  • Informed consent documents
  • Investigator Brochures
  • Clinical study reports
  • Abstracts, posters and manuscripts
  • Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
  • Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
  • Risks / benefits analysis for applicable documents
  • Clinical Development Plans
  • Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
  • Provide scientific expertise for selection of investigator and vendors
  • Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CRO's
  • Review, query, and analyze clinical trial data
  • Interpret, and present clinical trial data both internally and externally
  • Represent a clinical study or development program on one or more teams or sub teams
  • Create clinical study or program-related slide decks for internal and external use
  • Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
  • Contribute to or perform therapeutic area/indication research and competitor analysis
  • Build strong relationships with internal experts
  • Identify continuous process improvement opportunities
  • Identify incremental organizational resource needs – staff, budget, and systems
  • Develop, track, execute and report on goals and objectives
  • Support budget planning and management
  • Be accountable for compliant business practices

Required Education:

  • Advanced degree …
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