Department: Clinical Development
Employment Type: Regular
Reference Number: R50
Job Description Summary
Mirati is looking for a talented Medical Director to join the Clinical team. The successful candidate will have a passion for novel science, an affinity for strategic thinking, looking beyond the day-to-day execution, and will have a track record of keeping clinical programs on track and hitting milestones. The position will provide key overall clinical, scientific and/or logistical support to clinical development programs and is responsible for the compliance of the program to regulatory standards and procedures and will be graded according to the level of experience of the successful candidate.
Clinical leadership of global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements.
Help identify global study sites and foster relationships with study investigators
As the primary medical monitor for assigned study(ies), be the first point of contact with sites; answer site questions about eligibility, enrollment; safety and patient management
Chair internal and external clinical trial meetings-updating clinical staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues and presenting a plan of action for resolution of issues
Production of clinical documents required for the conduct of clinical studies, such as clinical protocols (and amendments as needed), informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices
Preparation of abstracts and posters for scientific meetings
Preparation of slides/ presentation at internal and external meetings, such as team meetings, Advisory Boards and Board of Director Meetings
Lead ongoing data interpretation to understand safety and efficacy profile of the investigational drug
Assist in preparation of clinical sections of key regulatory documents, e.g., IND annual reports and briefing packages
Present aspects of clinical program at Site Initiation Visits, Investigator's Meetings and scientific conferences
Maintain state-of-the-art knowledge of the principles and theory in relevant therapeutic areas
Assist in case report form (CRF) development and data analysis plans
Review project specifications for IRT/IXRS, ePRO, Imaging Charter for Central radiology review and other procedural documents
Perform in data cleaning and clinical study report review
Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study reference manuals
Assist in generation and update of Clinical Development Plan (CDP)
Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
What is Required
Medical Doctor (M.D.), either with Board Certification in Medical Oncology/ Hematology Oncology or Internal Medicine
5+ years of clinical development experience in the pharmaceutical or biotechnology industries with at least 2 years involvement in oncology drug development
Thorough working knowledge / understanding of clinical trial design, methodology and statistical concepts.
Phase IIII oncology clinical trial experience preferred.
Working knowledge of the IND/NDA process preferred.
In-depth knowledge of GCP/ICH guidelines preferred.
Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community.
Available for ~ 25% travel, including overnight stays.
Strong written and verbal communication skills required.
Ability to thrive in a fast-paced, dynamic small company environment with ability to adjust workload based upon changing priorities.
Leadership skills including a collaborative and team-oriented approach.
Good organizational, time management and interpersonal skills.
Demonstrated excellence in management skills, with track record of successfully managing multiple projects, trials, and priorities.
Ability to work well with global, multi-disciplinary teams.
$214,000 - $297,000
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