Executive Medical Director
Department: Clinical Development
Employment Type: Full Time
Reference Number: 1599611
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.
Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.
The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati's ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.
We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
Why join us?
Mirati is looking for a talented Executive Medical Director to join the Clinical team. In this role, the individual will be primarily focused on the MRTX849 program. MRTX849 (adagrasib) is a potent, highly selective, oral agent that irreversibly binds and inhibits KRAS G12C and is being evaluated in solid tumors harboring the corresponding gene mutation. 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. This is an ideal role for an individual who recently completed an oncology or other related medical fellowship.
- 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
- 10+ 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.
Personal Characteristics & Cultural Fit
- 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.
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.