Job Opportunity

Director, Clinical Development Scientist

Location: San Diego, California, United States of America
Department: Clinical Development
Employment Type: Regular
Reference Number: R53

Job Description Summary 

Collaborates with Clinical Development colleagues to efficiently design and effectively execute high quality clinical studies in close partnership with Clinical Operations. Your accountabilities include timely delivery of the protocol, clinical data review, and support of the appropriate interpretation and communication of data. As well as maintaining compliance with internal and external standards, mitigating risk and managing emerging clinical issues within the trial and being a contact for external investigators and internal study teams for questions relating to clinical/medical aspects of the protocol.

Your Responsibilities

  • In collaboration with the Medical Director, leads development and clinical/scientific execution of study protocols and amendments

  • Ensures appropriate data review, interpretation of study results, and reporting in collaboration with other functional groups.

  • Reviews and tracks emerging efficacy and safety data including adverse events and laboratory results, and keeps Medical Director informed of changes in the efficacy/safety as they occur and take action as appropriate

  • Conducts medical monitoring and addresses medical inquiries (only if Medically Qualified individual)

  • Works with the Medical Director to conduct routine safety reviews

  • Contributes to study documents, including ICF templates, eCRFs and SAE report forms

  • Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update reports, and clinical study reports

  • Supports and interfaces with Clinical Operations and study level project team throughout trial conduct

  • Collaborates with Medical Director to communicate study data results to colleagues, both internally and externally.

  • Assists with preparation of various presentations, including meeting abstracts, posters, oral presentations and advisory boards

  • Interprets, reports and prepares written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions

  • Assists with preparing responses to questions from Health Authorities and Ethics Committees

  • Prepares and may present scientific/clinical information at SIVs and internal and external meetings

  • Contributes to the clinical development strategy

  • Works closely with Quality to ensure flawless conduct of clinical aspects of trials

  • Ensures consistency across studies

  • Reviews medical literature and related new technologies

  • May support integrated document development for marketing authorization filing

  • May support preparation for the FDA Oncology Drug Advisory Committee and EU Oral Explanation

What is Required

  • Advanced medical degree preferred (not required)

  • Minimum of 10 years oncology clinical development experience

  • Significant experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports

  • In depth knowledge of regulatory guidelines and ICH/GCP

  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary

  • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams

Salary Range: 

$144,000 - $239,000

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus). 

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter