Careers

We believe that our current and future success as a biopharmaceutical company depends on the contribution and dedication of each of our employees. We are proud to have built a strong team of highly-motivated and skilled people. Thank you for your interest in Mirati Therapeutics.

To apply for one of the positions listed below, please send your cv to careers@mirati.com

Clinical Research Scientist/Clinician

Location: San Diego
Reporting to: Executive Director, Clinical Science

Responsibilities:

  • As a Clinical Research Scientist/Clinician, this person will be responsible for the design, implementation, conduct, interpretation and reporting of clinical trials
  • 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
  • Develop and/or oversee the development of 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
  • Provide oversight of study conduct and integrity, data quality, planning and execution of interim and final analyses and study reporting

Qualifications and Experience:

  • 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
  • Knowledge of clinical science, clinical operations and clinical project management
  • 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

Senior Director of Regulatory Affairs

Location: San Diego, California Reporting: Chief Medical Officer

Responsibilities:

  • Provide input into the strategies for clinical development to optimize the likelihood of successful global registration of pharmaceutical products; ensure development complies with the requirements of global regulatory authorities, including FDA, EMEA and other key countries in Asia and Latin America;
  • Drive, manage and advise on preparation of all regulatory filings and completion of submissions required for maintenance of INDs and NDAs in a timely manner;
  • Prepare and coordinate documentation, including investigator brochures, protocols, amendments, study reports;
  • Maintain up to date knowledge of local and global legislation, guidelines and clinical practices relevant to drug development, particularly in oncology;
  • Develop and maintain productive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, clarification, and follow-up of submissions;
  • Negotiate with regulatory authorities in all activities leading up to submission of NDAs or BLAs as well as in all regulatory activities required  to obtain registration;
  • Supervise the preparation of electronic filing documents;
  • Help plan and develop clinical trials and interpret trial data;
  • Initiate and manage regulatory inspections as required by regulatory authorities;
  • Review company practices and provide advice on changes to SOP’s and Quality Systems;
  • Adhere to strict timelines and deadlines for submission of documents;
  • Advising on CMC regulatory requirements.

Qualifications and Experience:

  • M.S. or PhD and 7+ years direct regulatory experience in pharmaceuticals, biopharmaceuticals or the biotechnology industry;
  • Recent and extensive experience with oncology regulatory filings, preferably including experience with global registration studies, including  in the US, EMEA and other key countries;
  • At least 2 years experience in a senior regulatory role with history of project management success;
  • Prior history of working successfully in a team environment with ability to work productively with clinical development and management;
  • Hands-on regulatory filing experience preparing IND and NDA submissions in either drugs or biologics;
  • Strong experience with face to face interactions with global regulatory agencies and solid knowledge of current FDA regulations and guidelines;
  • Excellent written and oral communication, technical writing, and editing skills;
  • Strong organizational and project management skills;
  • Excellent knowledge of pharmaceutical development process;
  • Ability to manage multiple projects;
  • Prior history of meeting deadlines and be detailed oriented.

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