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Clinical Scientist

Company: Mirati Therapeutics
Location: San Diego
Posted on: March 18, 2019

Job Description:

RESPONSIBILITIES:

  • 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
  • Primary responsibility for implementation and oversight of clinical trial in assigned program(s), along with timelines, and budgets
  • 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
  • Overall clinical program management, leading team meetings and teleconferences with investigators
  • Vendor oversight of CROs and specialty services
  • 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 REQUIREMENTS:
    • Recognized as an intellectual leader in the biopharmaceutical industry with an extensive BS (Science degree) with 7+ years, MS/RN with 5+ years, MD or PhD with 3+ years of clinical development experience in industry setting, Oncology therapeutic area expertise preferred
    • Broad and deep knowledge of clinical science, clinical operations and clinical project management
    • Phase III experience and participation in a clinical program through NDA highly desirable
    • Experience with CRO oversight
    • 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 EDUCATION:
      • Recognized as an intellectual leader in the biopharmaceutical industry with an extensive BS (Science degree) with 7+ years, MS/RN with 5+ years, MD or PhD with 3+ years of clinical development experience in industry setting
      • Oncology therapeutic area expertise preferred EOE

        Keywords: Mirati Therapeutics, San Diego , Clinical Scientist, Healthcare , San Diego, California

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