Medical Director, Clinical Development - Needham

Only for registered members Needham, United States

1 month ago

Default job background
Full time $275,000 - $325,000 (USD)
Job summary:

Job Summary

pBlue Earth Diagnostics is seeking a Medical Director – Clinical Development to provide medical expertise and strategic leadership to product development programs across the Bracco Molecular Imaging (MI) platform./p
  • Provide medical leadership within cross-functional Program Management Teams and projects related to clinical development.
  • Provide medical expertise to BED/Bracco MI clinical development programs and strategy including Phase I to successful product approval, and lifecycle management.
Responsibilities:

Main Responsibilities Activities Duties Tasks
  • Developing the product development strategy for pipeline assets with cross-functional partners
  • Serving as the primary medical representative in regulatory interactions related to product development
  • ,
    ,Qualifications:
    ,
    ul
  • Clinical care —and research experience in therapeutic areas where we have products/developmental assets preferred,/lili>Clinical trials & FDA approval processes preferably with experience of FDA interactions,/liriKnowledge & understanding of US regulatory rules landscape pertinent FDA Guidance for Industry,/liriStrong business & product marketing acumen vision perspective,/lilAbility lead teams empower others ensuring quality deliverables ,Ability comprehend combine complex sets data spanning multiple projects products/agenciestrilHandle demands fast-paced environment interact multidisciplinary teamwork /lilAble proactively identify issues problems describe assess risk chances success offer solutions recommendations develop issuesstrong decision-making under conditions uncertainty/trilIf required able manage recruit high-quality personnel form highly effective teamstrilateral Ability travel domestic international estimated approximately 30% via airplane train motor vehicle will be required/qQualified candidate must legally authorized employed United States./lit,
    ,Benefits: We also offer comprehensive benefits package including complete healthcare plan 401k matching work-life harmony generous paid holidays.
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