Title: Medical Director/Senior Medical Director

Location: Waltham, MA

Responsible for developing an innovative clinical strategy for assigned programs, ensuring efficient advancement of these  programs, coordinate and monitor the clinical studies ensuring compliance with ICH/GCP and federal regulations and collaborating with other functions to advance the Entasis portfolio.

Primary Responsibilities

  • Provide medical and clinical development expertise to the clinical development program in conjunction with other relevant functional areas·   
  • Design and draft protocol synopses, clinical trial protocols and protocol amendments.
  • Provide medical oversight of multiple clinical studies and provide medical input and guidance on scientific, clinical and safety monitoring issues
  • Provide medical and scientific expertise to preclinical discovery teams for compounds that are in preclinical development
  • Interface with US/international regulatory authorities, as appropriate, in of the development objectives and assist in the compilation of submissions and responses to inquires
  • Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements

Knowledge and Skill Requirements

  • MD required, subspecialty training in Infectious Disease is preferred
  • 5+ years of hands on pharmaceutical/biotechnology industry experience in clinical development
  • In depth knowledge of drug development process and oversight of clinical trials
  • Working knowledge of biostatistics, regulatory, clinical pharmacology and pharmacokinetics
  • Ability to manage multiple tasks and prioritization skills
  • Excellent interpersonal and communication skills (written and verbal)
  • Experience in filing US INDs and/or NDAs

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