Medical Director/Medical Monitor

Responsibilities:

  • As a Medical Director/Medical Monitor, this person will provide medical expertise and leadership during the design, implementation, conduct, interpretation and reporting of clinical trials
  • The candidate will work closely with other members of the, Medical Directors group, Clinical Science group, members of Mirati's development and Executive Leadership teams, external vendors and contract research organizations (CROs), to establish and execute the clinical development strategy for one or more compounds from lead development in discovery to Phase I-III clinical trials
  • Lead and drive the strategy of clinical development plans
  • Responsible as the Medical Monitor for assigned programs and back-up for other Medical Monitors as necessary
  • Author and oversee the Safety Risk Management Plan for assigned programs
  • Advise during the development of and review all documents required for the conduct of clinical trials
  • Provide direction and participate in the selection of study investigational sites and maintain relationships with investigators and key opinion leaders
  • Participate in vendor selection and oversight of full service CROs and specialty services
  • Collaborate in oversight of study conduct and integrity, data quality, planning and execution of interim and final analyses and study reporting
  • Author and oversee content of program level documents, including Investigator Brochures, Regulatory briefing documents, responses to regulatory queries, clinical sections of market applications
  • Establish, promote and maintain relationships with external groups including Investigators, Advisory Boards and Regulators

Qualifications:

  • Medical Doctor with Oncology therapeutic area expertise and 5+ years of clinical development experience in industry setting
  • Knowledge of clinical research experimental design, including fundamental understanding of statistical principles
  • Expected competencies:
    • Working knowledge of ICH/GCP guidelines
    • Effective written/verbal communication (e.g. able to adjust style/contents to suit the audience/purpose)
    • Ability to work independently as well as collaboratively in a multidisciplinary setting
    • Ability to work well under pressure
    • Ability to apply technical expertise and make sound decisions
    • Ability to influence without authority
    • Flexibility and willingness to adapt in a changing environment