Department: Clinical Development
Employment Type: Full Time
Reference Number: 2422893
Job Description Summary
The Medical Director will act as a subject matter expert in Clinical Development providing medical and clinical leadership and oversight for Mirati Phase 1‑3 oncology clinical trial(s) as described in the responsibilities below. You will be responsible for being a single point of accountability for the clinical trial(s) you lead, effectively collaborating with external (eg, Investigators, regulatory agencies) and internal key stakeholders towards successful study implementation.
- 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.), preferably with Board Certification in Medical Oncology / Hematology Oncology or Internal Medicine
- Ideally 5-8 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.
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision - to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) - we celebrate diverse experiences without regard 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 information, 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.