1755458

Job Description Summary

The Associate Director, Quality Metrics will report directly to the Head of Quality Assurance. This individual will be responsible for the development, execution, and implementation of the Quality Metrics program at Mirati. The Associate Director, Quality Metrics will ensure that all aspects of the operational business (including contracted vendors) comply with cGMP regulatory requirements (US/EU/ROW), the Mirati Quality Manual and Policies, and site procedures. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.

Your Responsibilities

Reporting to the Head of Quality Assurance, the Associate Director, Quality Metrics will have the following responsibilities. These may include but are not limited to:

  • Develop, execute, and implement a robust and compliant Quality Metrics program which meets all regulatory requirements and according to Mirati Corporate Quality Manual and relevant SOPs.
  • Establish internal process for collection of data and information flow from all key quality systems and sources. This also encompasses relevant CMO data and information.
  • Author and present quarterly quality metrics reports to senior management. This includes data interpretation of analytical, manufacturing, compliance and regulatory data and drawing conclusions from data.
  • Verify the consistency of existing processes and highlight any trends. Provide a documented review of key quality indicators with support of SMEs to determine the need for changes in product or process specifications, manufacturing, or quality procedures and ensuring alignment with filing.
  • Establish review and verification process with key SMEs for the evaluation of trends and determination of CAPAs for inclusion in quarterly metrics reviews.
  • Ensure follow-up and closure of all CAPAs identified and linkage to other quality systems (e.g. Deviation trending reports, etc.)
  • Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with Mirati’s standard processes and quality systems.
  • Manage multiple projects and ongoing work activities within the function typically involving cross-functional representatives.
  • Complete annual assessment of health of Mirati Quality Metrics Program
  • Interface with Regulatory Agencies in audits, track, and report metrics for all internal auditing activities.
  • Other duties as assigned.

What is Required

  • Bachelor’s Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
  • 8-10+ years of experience in pharma/biopharma industry required.
  • Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance.
  • Experience in problem solving, process improvement, negotiations and supervision.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn.

Why Join?

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.

1755469

Job Description Summary

Reporting to the Head of Quality Assurance; the Director, GXP Auditing will be responsible for managing the GXP Audit function by ensuring compliance to applicable regulations, guidelines, and operating procedures. The Director, GXP Auditing will plan and conduct GXP audits, assess audit findings, and prepare and distribute reports of findings to senior management and contracted vendors as appropriate. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

Your Responsibilities

The Director, GXP Auditing will have the following responsibilities. These may include but are not limited to:

  • Develops and implements quality audit plans and maintains GXP Audit Schedule
  • Conducts and/or coordinates GxP compliance audits of third parties/vendors, (i.e. Routine or Non-Routine, pre-clinical, toxicology sites, clinical sites, manufacturing sites, etc.) in accordance with QA (Quality Assurance) risk-based processes
  • Assesses compliance of vendors processes against ICH (International Conference of Harmonization), applicable government agency regulations/ guidelines, as well as company policies, procedures and industry standards; applies comprehensive working knowledge of Quality Assurance, regulations and auditing
  • Evaluates audit findings and prepare and distribute reports to senior management
  • Monitors responses to audit observations and formulation of corrective action plans
  • Ensures corrective actions are taken to bring QA observations to closure as applicable
  • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
  • Coordinates Periodic Internal Audit Assessments
  • Assists the Head of Quality in host audits and/or inspections; Ensures proper conduct of partner-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
  • Manage vendor qualification audits in Veeva QMS and provides support in relation to the audit lifecycle
  • Develop, revise, implement and adhere to Quality Assurance department policies and procedures
  • Lead/collaborate/support in QA initiatives/projects for quality, process improvements
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
  • JustOther duties as assigned

What is Required

  • Bachelor’s Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
  • 10+ years of experience in pharma/biopharma industry required.
  • 4+ years previous clinical/nonclinical Quality Assurance experience conducting a broad range of audits.
  • Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance.
  • Experience in problem solving, process improvement, negotiations and supervision.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn.

Why Join?

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.

1754510

Job Description Summary

The Associate Director, GXP Vendor Management will report directly to the Senior Director, Quality Assurance. The Associate Director, GXP Vendor Management will be responsible for managing the GXP Vendor program by ensuring all Mirati vendors are qualified according to the applicable regulations and Mirati’s processes and procedures. The ideal candidate will have a strong quality assurance and quality systems background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.

Your Responsibilities

The Associate Director, GXP Vendor Management will collaborate with GXP Auditing function to ensure vendors are assessed, qualified and the applicable quality agreements are in place prior to GXP use. The Associate Director, GXP Vendor Management will have the following responsibilities.

These may include but are not limited to:

  • Develops and maintains the Quality Agreements Program at Mirati includes GCP, GLP and GMP vendors
  • Works closely with Supply Chain, Clinical, GXP Auditing and QA Operations to identify new Quality Agreements
  • Authors and ensures internal reviews (Mirati Legal, Supply Chain & Reg CMC & QA departments) and external reviews (i.e., corresponding vendor QA department) are conducted in a timely manner for all GXP Vendor Quality Agreements
  • Responsible for any periodic reviews and amendments of Quality Agreements including Quality Agreements with Mirati GXP Business Partners
  • Works closely with Mirati Supply Chain and third-party vendors to ensure all qualified vendors are inputted electronically in Veeva QMS and included on the Mirati Approved Vendor List
  • Works closely with Quality Metrics function to periodically provide applicable vendor performance and quality metrics
  • Works closely with QA Operations team and vendor QA to ensure corrective actions at vendors are completed to prevent Quality Events from recurring as applicable
  • Assist in developing, revising, implementing, and adhering to Quality Assurance department policies and procedures
  • Collaborate/support in QA initiatives/projects for quality, process improvements
  • Other duties as assigned

What is Required

  • Bachelor’s Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related scientific discipline required.
  • 8-10+ years of experience in pharma/biopharma industry required.
  • In depth knowledge of GDP and legal requirements.
  • Able to work well in a matrix organization set up and influence key stakeholders.
  • Able to influence indirect reports to deliver results.Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance.

Experience in problem solving, process improvement, negotiations and supervision

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on Twitter and LinkedIn.

Why Join?

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.

1740951

Job Description Summary

Reporting directly to the Director of Regulatory Operations, the Senior Manager of Regulatory Operations will be responsible for the technical preparation, submission, and archiving of all global regulatory submissions; ensuring that submissions are of high quality and submitted on-time. In addition to management of traditional regulatory operations functions, the SM/AD must also serve as the Business Administrator for Veeva Vault RIM.

The ideal candidate must have expert proficiency in regulatory agency submissions requirements, eCTD publishing, electronic document management, and be experienced in implementing and managing Regulatory Operations-specific software.

Your Responsibilities

  • Manage the compilation, publishing, and submission of electronic, hybrid, and paper
  • Manage the quality of regulatory submissions to ensure compliance with applicable technical
  • Manage regulatory filing goals through collaboration with cross-functional teams; ensuring accuracy of regulatory submission
  • Manage publishing service providers and contractors, as needed.
  • Manage Regulatory Operations timelines across all products for original and lifecycle
  • Perform other duties as required.

What is Required

  • BS and minimum 7-10 years’ experience working in a biotechnology or pharmaceutical Regulatory Operations environment.
  • Proven track record of generating eCTD compliant Expert understanding of eCTD publishing/validation concepts; experience with Global Submit PUBLISH, Veeva Vault RIM, Starting Point and DXC Toolbox is a plus.
  • Training and experience leading to expert use of programs used in regulatory submission
  • Advanced proficiency using MS Word, MS SharePoint, Adobe Acrobat Professional, as well as experience with MS Excel, MS PowerPoint, and MS
  • Expert knowledge of global regulatory health authority requirements for submissions, especially those relating to FDA submission requirements including document formatting and XML
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong communication skills both written and
  • Ability to multi-task and shift priorities rapidly to meet tight
  • Professional demeanor and an excellent written and verbal
  • Detail oriented and well organized.
  • Good and thoughtful
  • Enthusiastic, self-motivated and keen to improve processes and overcome

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1735409

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?

Our pipeline is one of the most robust and exciting in the industry and fuels our ambition to make great strides in the fight against cancer. By joining Mirati, you will become part of a leading biotech company with a team of talented professionals dedicated to bringing the latest innovations in cancer treatment to patients. With a focus on teamwork and a commitment to do everything we can to support healthcare professionals in their effort to care for patients, we are well positioned to raise expectations for what companies can do to advance cancer care. We are passionate and dedicated, nimble and fast and are committed to empowerment to enable speed and high-quality customer service. While we go about it, our commitment to do first what is right is unshakable and we promise to put patients first in all that we do.

Position Summary:

The Senior Manager of Quality Assurance will report directly to the Director, Quality Assurance. The individual will be responsible for supporting the designated QA lead on Mirati project teams. Under the direction of the Director of QA, this role will be responsible for review of GMP operations at contracted vendors in support of Mirati’s small molecule programs. Responsibilities may include reviewing applicable data in support of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong quality assurance / GMP operations background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.

Your Responsibilities:

Reporting to the Director, Quality Assurance; the Senior Manager, Quality Assurance will be responsible for supporting the Quality Assurance Operations function to ensure clinical trial material is manufactured and tested according to GMPs. The Senior Manager, QA will have the following responsibilities. These may include but are not limited to:

  • Review of executed batch records and disposition batches, certifying compliance with study, regulatory and GMP requirements.
  • Collaborate with Mirati CMC and Technical Operations colleagues to ensure timely technical reviews of batch records, escalating issues as necessary
  • Participation in weekly vendor meetings
  • Assist with review and approval of Master Batch Records & Packaging Records, etc.
  • Complete Batch Record review checklists for batch disposition
  • Generation of certificates of release and compliance, etc.
  • Ensure GMP compliance is maintained
  • Assist the Director of QA to assess investigations, and deviations and bring to closure in a compliant manner
  • Provide the support required to ensure timely implementation of corrective actions and escalate as necessary
  • Ensure products meet regulatory requirements
  • Support the review and approval of CMO change controls as required
  • May perform document change control activities (i.e., SOP writing) as needed
  • Develop, revise, implement and adhere to Quality Assurance department policies and procedures
  • Assist with maintaining file organization within the Quality department
  • Other duties as assigned

What is Required:

  • Bachelor’s or Masters’ degree in Life Sciences field or equivalent years’ experience, with 8+ years pharmaceutical industry experience and a minimum of 6 years in Quality Assurance.
  • Previous small molecule drug and NDA-level experience are a strong plus
  • Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international).
  • Quality Assurance experience supporting both development projects and commercial products.
  • Experience working with management and key business stakeholders.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

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 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.

1631140

Job Description Summary

Reporting to the Head of Quality Assurance, the Director, Clinical Quality Assurance will lead the Clinical Quality function within the QA department and collaborate cross-functionally with the various Mirati GXP departments to ensure GCP compliance at Mirati and Mirati’s approved vendors and clinical sites.

Your Responsibilities

  • Accountable for GCP compliance for ongoing Mirati clinical trials
  • Identify compliance risks and implement risk mitigation measures where applicable
  • Ensure Inspection Readiness of Mirati’s clinical programs, including ensuring Inspection Readiness at Mirati’s approved vendor and clinical sites as appropriate
  • Work with Clinical and Medical to Assess Vendor Classification Level
  • Oversight of Clinical Vendor Qualifications including, External GCP and GLP Audits, Performing Audit Assessments and Authoring and/or Reviewing Audit Reports
  • Responsible for Drafting and Maintaining Current Quality Agreements with clinical vendors
  • Maintain the GCP and GLP Audit Schedule (Internal & External)
  • Manage internal and external GCP and GLP audits and inspections to ensure compliance with established quality assurance processes, standards, regulatory guidelines
  • Ensure product complaints arising for investigational products are managed and investigated to ensure compliance with worldwide regulations for clinical trials and nonclinical studies
  • Work with Regulatory to review IND submissions ensuring compliance
  • Ensure clinical documentation in support of Trial Master File is archived and reviewed appropriately
  • Conduct QC reviews of Clinical Protocols, IBs, and IND / IMPD Amendments
  • Manage periodic GCP refresher training and SME inspection readiness training
  • Develop, revise, implement and adhere to clinical QA department policies and procedures
  • Develop Clinical Quality organization as appropriate to support the volume of development projects

What is Required

  • Bachelors’ or Masters’ degree in Life Sciences field or equivalent
  • Fifteen+ years pharmaceutical industry experience with a minimum of ten years in Quality Assurance.
  • Previous small molecule drug experience is a strong plus
  • Established working knowledge of Good Clinical Practices and other applicable regulations (US and international).
  • Quality Assurance experience supporting all phases of clinical trials.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1666012

Job Description Summary

Mirati is looking for a talented Associate Director, Regulatory Affairs to join our growing team and provide key support to the Regulatory Affairs department. This position has primary responsibility for coordination and assembly of regulatory documents for review and submission to health authorities (primarily the FDA, other regulatory agencies as needed) and assists GRLs with strategies and submissions as appropriate. The Associate Director, Regulatory Affairs will be responsible for maintaining and updating archival copies of health authority submissions (e.g. IND, BLA, and MAA). The Associate Director, Regulatory Affairs will ideally have a working knowledge of regulatory requirements specific to key regions such as the US, Canada, and EU, and have a general awareness of current global trends in Regulatory Affairs.

Your Responsibilities

  • Under the direction of a senior Regulatory staff member, prepare, compile review, and submit documents for the company, including but not limited to initial INDs/CTAs/BLAs and amendments or supplements.
  • Assist regulatory management and project teams in the implementation of regulatory plans and timely delivery of regulatory documentation.
  • Develop, maintain, and communicate timelines for regulatory submissions.
  • Participate in the review of critical documents such as: protocols, ICFs, IBs, CSRs, DSURs, etc to ensure they are compliant with relevant regulations and guidance (e.g. ICH, FDA, EMA, etc.) prior to submission.
  • Coordinate with Regulatory Operations to gather and assemble information necessary for submissions to health authorities in accordance with regulations and guidelines.
  • Maintain databases of regulatory information, submissions and correspondence.
  • Follow general instructions to complete projects while independently planning daily work to complete time sensitive assignments.
  • Review, write, and present guidelines and SOPs as needed to support high quality submissions and assure adherence to regulatory requirements.
  • Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration

What is Required

  • A minimum of a BS in life sciences with at least 8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries (an equivalent combination of education and experience may be considered).
  • Understanding of the drug development process and knowledge of global guidance and regulations.
  • Has successfully supported health authority submissions and critical projects while maintaining agreed timelines.
  • Previous experience with IND filings or maintenance required and previous experience with eCTD formatted submissions and NDA or BLA filings desirable
  • Excellent oral and written communication skills.
  • Time management skills are essential.
  • Demonstrated ability to work effectively with cross-functional teams e.g. research, clinical, and CMC teams.
  • Ability to implement regulatory plans and strategies and proactively identify risks.
  • Ability to work on multiple tasks to meet company objectives.
  • Strong attention to detail.
  • Knowledge of 21 CFR and FDA, ICH, GCP, GMP, eCTD, and global guidelines.
  • Excellent Computer Skills MS Word, Excel, Power Point, and document management software/system.
  • Previous experience with building electronic submissions in compliance with Health Authority requirements is a plus
  • Previous experience with maintaining in house repository for archiving regulatory submissions and Health Authority correspondence in 21 CFR Part 11 compliant system (eg, Veeva) is a plus

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1666025

Job Description Summary

The Senior Drug Safety Associate will provide support for Mirati Safety Operations including QC/ QA of Individual Case Safety Reports (ICSRs), SAE reconciliation, signal detection, literature surveillance, and support other Pharmacovigilance activities as needed. Responsible for day-to-day Quality review of ICSR’s including Narratives, Product coding, Medical coding, other case fields and for any possible discrepancies with the related source documents.

Your Responsibilities

  • Review and update follow-up queries as appropriate.
  • Review regulatory reports required for ICSR submissions on a case by case basis.
  • Perform SAE reconciliation with appropriate CRO data management personnel and Mirati team members as applicable.
  • Address any case-processing related queries during CRO/partner reconciliation.
  • Review, update and maintain Data Entry Guidelines as applicable.
  • Serve as the Compound lead to address any questions related to SAE reconciliation activities. Provide SAE reconciliation metrics/compliance updates during study meetings.
  • Assist with Literature surveillance activities.
  • Perform User acceptance testing in the safety database development environment for data-entry related changes before rolling to production.
  • Support signal detection and evaluation activities in accordance with SOPs and guidelines.
  • Develop and maintain Pharmacovigilance SOPs/work instructions as required.
  • Ensure audit preparedness and support regulatory inspections.
  • Under the direction/review of senior PV staff, participate in other PV and Risk Management activities, as needed.

What is Required

  • Bachelors’ Degree or higher nursing, pharmacy or related health care field (required).
  • At least 7 – 8 years’ experience in a drug safety/pharmacovigilance case processing role with minimum 4 years’ experience as ICSR Quality Reviewer.
  • Relevant experience in the oncology therapeutic area, preferred.
  • Experience needed with drug safety database (ARGUS, preferred).
  • Experience with coding verbatim AE terms, medical history, laboratory data, and products using MedDRA and WHO-Drug dictionaries.
  • Knowledge and experience with case-processing guidelines as per local and Global GVP requirements.
  • Strong communication and narrative writing skills.
  • Knowledge with US/Global safety reporting and regulatory compliance.
  • Competent in Microsoft Word, PowerPoint, Excel.
  • Strong attention to detail.
  • Ability to work independently.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1669152

Job Description Summary

Reporting directly to the VP of Regulatory Affairs and Quality Assurance, the Senior Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing documents for Health Authority meetings, as well as responses to requests. The ideal candidate should have a working knowledge regarding Regulatory CMC to collaborate cross-functionally as appropriate. This individual will provide regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and future commercial products.

Your Responsibilities

  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
  • Provide regulatory leadership and guidance to project teams and commercial function as appropriate
  • Develop response strategies and submissions to regulators
  • Develop briefing packages for meetings with FDA and other global health authorities
  • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial)
  • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
  • Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
  • Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
  • Provide critical review of all documentation supporting regulatory applications
  • Identify and assess regulatory risks for assigned projects or programs
  • Prepare and deliver effective presentations for external and internal audiences
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate
  • Participate and contribute in Health Authority meetings as required
  • Manage direct reports as appropriate

What is Required

  • Bachelor of Science in a scientific discipline, advanced degree highly preferred.
  • Prior pharmaceutical industry experience and a minimum of 10 years in Regulatory Affairs
  • Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents
  • Previous small molecule drug and NDA-level experience are a strong plus
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and commercial products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

1621510

Job Description Summary

The Associate Director of Quality Assurance will report directly to the Senior Director, Quality Assurance. The individual will be responsible for representing QA on Mirati project teams and overseeing the GMP operations at contracted vendors in support of Mirati’s small molecule programs. The individual will also be responsible for reviewing applicable data in support of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong quality assurance / GMP operations background, experience with small molecules, and regulatory inspections. In addition, excellent verbal and written communications skills are required.

Your Responsibilities

Reporting to the Senior Director, Quality Assurance; the Associate Director, Quality Assurance will be responsible for assisting the Quality Assurance Operations function to ensure clinical trial material is manufactured and tested according to GMPs. The Associate Director, QA will have the following responsibilities.

These may include but are not limited to:

  • Review of executed batch records and disposition batches, certifying compliance with study, regulatory and GMP requirements.
  • Collaborate with Mirati CMC and Technical Operations colleagues to ensure timely technical reviews of batch records
  • Participation in weekly vendor meetings representing Mirati QA
  • Assist with review and approval of Master Batch Records & Packaging Records, etc.
  • Complete Batch Record review checklists for batch disposition
  • Generation of certificates of release and compliance, etc.
  • Ensure GMP compliance is maintained
  • Work with CMOs to assess investigations, and deviations and bring to closure in a compliant manner
  • Ensure timely implementation of corrective actions and escalate as necessary
  • Ensure products meet regulatory requirements
  • Review and approve CMO change controls as required
  • May perform document change control activities (i.e., SOP writing) as needed
  • Develop, revise, implement and adhere to Quality Assurance department policies and procedures
  • Assist with maintaining file organization within the Quality department
  • Other duties as assigned

What is Required

  • Bachelor’s or Master’s degree in Life Sciences field or equivalent years experience, with 10+ years pharmaceutical industry experience and a minimum of 8 years in Quality Assurance.
  • Previous small molecule drug and NDA-level experience are a strong plus
  • Established working knowledge of Good Manufacturing Practices and other applicable regulations (US and international).
  • Quality Assurance experience supporting both development projects and commercial products.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

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 KRAS G12C 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 KRAS G12D 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.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

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.

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