Rho

Medical Director, General Medicine

Rho

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

About the role

  • Serve as Medical Advisor on assigned projects.
  • Provide medical support to investigative sites and project staff for protocol-related issues.
  • Perform review and clarification of trial-related Adverse Events (AEs) and coding.
  • Perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narratives.
  • Perform medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
  • Perform medical review of the Clinical Study Report (CSR), patient narratives, and other high-profile documents such as marketing application, clinical safety/efficacy summaries and overviews.
  • Serve as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned projects.
  • Participate in the development of Medical Monitoring portion of client proposals including the budgeting process.
  • Support Business Development activities by reviewing and providing medical/scientific input and guidance on Requests for Proposals (RFP), as well as being an active participant and Rho representative at bid defense and other meetings with sponsors.
  • Support Feasibility activities as required.
  • Consult with senior management, customers, and project teams to ensure the safety of subjects in clinical trials; ensure the scientific and ethical integrity of clinical trial design and conduct; provide medical input to clinical programs; and provide clinical development and regulatory input as needed.

Requirements

  • A medical degree from a fully accredited medical school as well as holding (or having held) an active medical license in good standing
  • 5+ years of experience in clinical medicine beyond residency and 5+ years of clinical development experience (ideally in the pharmaceutical or a closely related industry)
  • Good understanding of a wide range of general clinical medicine
  • Good understanding of research methodologies and clinical trial design, including biostatistics
  • Good understanding of scientific and ethical regulations and guidelines pertaining to clinical research, including knowledge of federal drug development regulations and guidelines
  • Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives
  • Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
  • Ability to establish and maintain cooperative and effective working relationships with coworkers, managers, and clients
  • Excellent communication and interpersonal skills, ideally with experience/expertise in public speaking and engaging external stakeholders