Medical Monitor/Senior Medical Monitor

Reporting to: VP, Clinical Research

Summary:

The Medical Monitor is a key member contributing to the development and execution of early-stage clinical development. In addition to preparing clinical trial protocols and monitoring adverse events and study management, he/she will be an integral team member working closely with Tolero Senior Management to develop and maintain an innovative culture and environment.

Responsibilities:

Phases I-II Research & Development Activities
  • Supports clinical early-stage clinical protocol development and CRO selection
  • Oversees day-to-day clinical trial activities such as patient eligibility, enrollment, AE/SAE review, investigator and/or site requests, CRF monitoring, database queries, and other related responsibilities
  • Engage closely with CROs
  • May represent Tolero on project teams
  • Provides direction to translational research assay development and requirements
  • Provides project updates at the Tolero meetings upon request
  • Effective collaboration with other Tolero departmental efforts
  • Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing

Qualifications:

  • M.D. or D.O. with oncology research experience
  • Minimum of 3 years of industry experience or outstanding educational background involving oncology clinical trials
  • Oncology clinical trials
  • Experience with clinical trials process including IRB, ethics committees, SAE management and reporting
  • Sense of urgency and perseverance to achieve results
  • Demonstrated ability to operate in a dynamic and fast-paced environment and manage complex scientific circumstances
  • Strong verbal, written communication, interpersonal, listening, and organizational skills required
  • Unquestionable ethics, professional integrity, and personal values consistent with the Tolero values
  • Ability to work in a diverse environment
  • Demonstrated ability to adapt to changing priorities and tolerate uncertainty and ambiguity
  • Demonstrated ability to facilitate appropriate team decisions
  • Familiarity with medical terminology, FDA and ICH regulations/guidance specific to clinical research and general product development in the pharmaceutical industry

Please send resumes to career@toleropharma.com