Job Description Associate Director, Clinical Operations/Clinical Scientist


  • Primary responsibility for implementation and oversight of clinical trial in assigned program(s), along with timelines, and budgets
  • Overall clinical program management, leading team meetings and teleconferences with investigators
  • Vendor oversight of CROs and specialty services
  • Develop and/or oversee the development of documents required for the conduct of clinical trials, such as Investigator’s Brochures, clinical protocols, informed consent documents, study quality management/monitoring/safety management/data management/statistical analysis plans, in compliance with federal regulations and good clinical/medical practices
  • Provide direction and participate in the selection of study investigational sites, vendors and consultants
  • Management of external data monitoring committees and central review services
  • Ongoing data review for safety and to ensure data quality
  • Planning and execution of interim and final analyses and study reporting
  • Data interpretation and medical writing of study reports, conference abstracts, and manuscripts for publication
  • Contribute to the clinical sections of regulatory documents, e.g., INDs and CTAs, IND annual report and briefing documents
  • Maintain relationships with investigators and interact with key opinion leaders
  • Presentations to senior management, scientific and clinical advisory boards, as well as participation in business development activities
  • The candidate will work closely with other members of the Clinical Science group, Medical Directors, 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


  • BS (Science degree) with 5+ years, MS/RN with 3+ years, MD or PhD with 2+ years of clinical development experience in industry setting, Oncology therapeutic area expertise preferred
  • Broad and deep knowledge of clinical operations, clinical development, and clinical project management
  • Phase III experience and participation in a clinical program through NDA highly desirable
  • Experience with CRO management
  • 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
    • Ability to travel