1746643

Job Description Summary

Mirati is looking for a Senior Safety Systems Associate to join our growing team. This position is primarily responsible for performing all pharmacovigilance (PV) Systems activities for both the US & Globally. Responsibilities include maintenance of Argus & PVQ systems, supporting PV Operations and performing audit related activities. The individual will be responsible to maintain all updates on Industry/ Regulatory standards for PV systems. He / She will be responsible for implementation of new PV applications to support PV Operations, Signal Detection and Risk Management activities. The successful candidate will have the ability to work independently and also as a part of the team. The successful candidate will have the ability to work in a dynamic, changing environment to meet corporate and patient needs.

Your Responsibilities

  • Collaborate with database hosting vendor to implement system changes (e.g., study/product configurations, user access requests, etc.,) as needed to support PV business needs.
  • Collaborate with database hosting vendor to upgrade MedDRA and WHO Drug dictionaries for Argus Safety Database as per PV requirements.
  • Responsible for tracking all managed service tickets and ensuring timely and adequate follow-up from the database hosting vendor.
  • Perform UAT testing as needed for any PV system.
  • Perform Disaster Recovery activities for Argus and PVQ on a periodic basis.
  • Provide overview training on Argus safety database to new PV staff and perform user account maintenance review on a periodic basis.
  • Liaise with partners to implement and support XML transmission activities.
  • Configure and retrieve data listing requests to support expedited reporting, monthly safety reviews, SAE reconciliation activities, periodic reports and ad-hoc requests, as needed.
  • Management of Argus Safety database upgrades including interfacing with the database hosting vendor and Mirati IT & Quality Assurance.
  • Setting up Electronic E2B gateways for submissions to Health Authorities.
  • Partnering with Mirati Data Management to setup electronic SAE reporting from the clinical database (RAVE).
  • Support internal audit/inspection activities by providing data listings from Argus/PVQ.
  • Ensuring pre-approval inspection readiness regarding all necessary Argus/PVQ documents.
  • Preparation and management of necessary SOPs related to Argus/PVQ.
  • Selection and implementation of data visualization and analytics software (e.g., Spotfire) for signal detection activities.
  • Perform routine regulatory intelligence activities related to changes in impacting PV systems.

What is Required

  • At least 5 years’ experience in a Safety systems role in the pharmaceutical industry with focus on knowledge of Argus console configurations and maintenance.
  • Bachelor’s degree or higher in life science or computing degree
  • Knowledge of PV systems and processes (Argus, Cognos etc.)
  • Knowledge of GCP and ICH Guidelines
  • Proficient in Microsoft Office products (including Word and Excel)
  • Experience with SQL and/or PL/SQL required
  • Knowledge of GxP software applications
  • Knowledge of Data visualization and analytics software

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.

1746692

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.

Your Responsibilities

  • 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.
  • 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 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.

1666026

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.

Your Responsibilities

  • 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.

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.

1744291

Job Summary:

Mirati is seeking a Clinical Development Scientist to work directly with the Medical team on ongoing clinical programs.

Your Responsibilities

  • In collaboration with the Medical Director, leads development of study protocol and amendments
  • Routinely reviews clinical study data, querying discrepant data points to ensure accurate data reporting and significant focus on data quality
  • Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
  • 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 AE section of ICF templates, eCRFs and SAE report forms
  • Ensures consistency across studies
  • Collaborates with the clinical development team on analysis and interpretation of study results
  • Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update 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
  • 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
  • Contributes to clinical study report content
  • Assists with preparing responses to questions from Health Authorities and Ethics Committees
  • Supports general Clinical/Medical Affairs activities involving product evaluation, labeling & surveillance
  • 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 degree in a scientific discipline, minimum of master’s degree; PhD, MD, PharmD, DO preferred
  • 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

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.

1665996

Job Description Summary

Mirati is looking for a Drug Safety Scientist to join our growing team. This position is primarily responsible for performing and contributing to safety documents, including safety queries, RMP, DSUR, PSUR/ PBRER in support of regulatory and partner reporting requirements. The Drug Safety Scientist will work collaboratively with Pharmacovigilance and Safety Risk Management colleagues and other teams to conduct safety surveillance activities and provide scientific drug safety/PV expertise with a focus on the signal detection, evaluation and management of safety risks for assigned investigational and/or marketed products throughout the products’ lifecycle(s). The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Your Responsibilities

  • Active participation on drug safety and pharmacovigilance teams’ activities including performing case series review and tabulated/line-listings data review for identifying and assessing safety signals and adequately documenting discussions, conclusions and decisions.
  • Project manage signal detection activities including the searching of databases, literature, and other sources of data, preparing safety signal reports for drug safety evaluation, and performing ad hoc analyses as required
  • Draft and author responses and safety documents including safety queries, RMP, DSUR, PSUR/ PBRER, IB and others upon request.
  • Assist/contribute the risk management documents, including Risk Management Plans and Risk Minimization Plans or REMS for submission to regulatory agencies.
  • Participate in inspection readiness activities and preparation as needed
  • Perform aggregate safety analysis and case level review, and author and coordinate the preparation of core safety deliverables
  • Recognize potential issues and/or safety issues and escalate to the attention of the report owner, line manager.
  • Attention to detail and ability to analyze data in broader context, ability to (re)prioritize work/tasks of oneself and others
  • Draft and author Standard Operating Procedures (SOPs) and Work Practice Instructions.
  • Other functionality and assignments as mandated by business need

What is Required

  • Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree.
  • Minimum 2 years of experience in drug safety science role in biotech or pharmaceutical industry.
  • Competent knowledge of good pharmacovigilance practices, US and EU pharmacovigilance regulatory requirements.
  • Knowledge and experience with safety signal detection and management, safety surveillance, labeling analyses, and ad hoc safety analyses
  • Experience with development and authorship of aggregate reports (i.e., DSUR, PSUR), Risk Management Plans, and SOPs/working instructions
  • Worked with a drug safety database (ARGUS) and strong working knowledge of MedDRA and WHO Drug coding dictionaries
  • Excellent written and oral communication skills
  • Competent in Microsoft Word, PowerPoint, Excel
  • Ability to work independently and strong attention to detail
  • Relevant experience in the oncology therapeutic area, strongly preferred

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.

1688120

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.

Responsibilities:

  • In collaboration with the Medical Director, leads development of study protocol and amendments
  • Routinely reviews clinical study data, querying discrepant data points to ensure accurate data reporting and significant focus on data quality
  • Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
  • 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 AE section of ICF templates, eCRFs and SAE report forms
  • Ensures consistency across studies
  • Collaborates with the clinical development team on analysis and interpretation of study results
  • Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update 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
  • 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
  • Contributes to clinical study report content
  • Assists with preparing responses to questions from Health Authorities and Ethics Committees
  • Supports general Clinical/Medical Affairs activities involving product evaluation, labeling & surveillance
  • 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

Requirements:

  • Advanced degree in a scientific discipline, minimum of master’s degree; PhD, MD, PharmD, DO preferred
  • 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

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.

1582374

Job Description Summary

Mirati is looking for a Safety Medical Reviewer to join our growing team. This position is primarily responsible for performing medical review and assessment of serious adverse event reports that are processed. This involves checking for accuracy and completeness of ICSRs and ensuring accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding). Additional responsibilities include providing support for other investigational and marketed products. This includes pre- and post-marketing safety, Pharmacovigilance (PV) and preparing / supporting signal detection, aggregate safety reports (DSUR/PSUR) and risk management activities. The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Your Responsibilities

  • Perform medical review and assessment of serious adverse event (SAE) reports that are processed, checking for accuracy and completeness of ICSRs.
  • Ensure accurate capture of safety data within patient narratives and critical data fields which impact medical evaluation (i.e. seriousness, causality, expectedness assessment, MedDRA coding).
  • Prepare Analysis of Similar Events (AOSE) summary for SUSARs requiring safety reporting.
  • Perform signal detection activities including the searching of databases, literature, and other sources of data, preparing safety signal reports for safety evaluation, and performing ad hoc analyses as required
  • Support or draft safety related documents (e.g. IB, DSUR, PSUR/PBRER and RMP) and safety responses regarding safety issues.
  • Contribute to vendor oversight activities / interactions from a scientific / medical safety perspective and participate in inspection readiness activities and preparation as needed.
  • Involved in internal process improvement activities such as SOPs or guidance documents as assigned.
  • Under the direction/review of senior PV staff, participate in other PV and Safety Risk Management activities as necessary

What is Required

  • Medical Doctor (MD), Doctor of Osteopathic Medicine (DO) or Nurse Practitioner (NP) with 2 years of experience in Drug Safety and PV
  • Experience with drug safety databases (ARGUS experience a plus) and the responsibility for medical review of SAE reports
  • Thorough knowledge of current US, Global, and ICH safety reporting regulations and guidelines
  • Strong working knowledge of MedDRA and WHODrug coding dictionaries
  • Excellent written and oral communication skills in the English language, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
  • Competent in Microsoft Word, PowerPoint, Excel
  • Ability to maintain an “inspection ready” environment
  • Ability to work independently and strong attention to detail
  • Solid medical knowledge of methods to assess causality relationship between adverse events and administration of investigational and marketed products
  • Relevant experience in the oncology therapeutic area, strongly preferred

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.

1593015

Job Description Summary

Mirati is looking for a Senior Director, Global Safety Officer (GSO) to join our growing team. This position is responsible for establishing the strategy, direction, and priorities of pharmacovigilance activities and is accountable for the overall safety profile and all product-related decisions and deliverables for the assigned product(s). The GSO will lead and manage safety collaborations with development partners. The GSO will partner with internal stakeholders on establishing NDA safety strategies. This individual will also support other investigational and marketed products. This includes all pre- and post-marketing safety, Pharmacovigilance (PV) and supporting signal detection and risk management activities. This individual will manage and mentor the Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s). The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Your Responsibilities

  • Establishing the strategy, direction, and priorities of pharmacovigilance activities and is accountable for the overall safety profile and all product-related decisions and deliverables for the assigned product(s)
  • Identification, analysis and reporting of possible safety trends and concerns with assigned Mirati product(s), including the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience, review of relevant literature articles, product quality complaints and non-clinical safety data
  • Research and carry out signal detection activities utilizing internal and external sources of investigational or marketed product safety data
  • Perform safety analyses and present these at cross-functional Safety Review Committee meetings and to Senior Management and prepare presentations for Board of Director Meetings
  • Lead the development, implementation and coordination of risk mitigation strategies (e.g. Risk Management Plans, REMS, Post-Marketing Evaluation Programs), to ensure the safe and appropriate use of Mirati products, in compliance with global legal and regulatory requirements
  • Lead the production of all relevant regulatory documentation (e.g. IND Annual Reports, DSUR, PSUR) as well as support the production of clinical documentation (e.g. Protocols, IBs, ICFs)
  • Lead collaboration with business partners around safety data evaluation and safety data exchange, including the creation of safety data exchange agreements and safety management plans, review of safety materials received from our partners
  • Lead PV responses to medical inquiries regarding safety issues, ad hoc requests from regulatory agencies, ad hoc requests to support CTAs with study sites, etc., as needed
  • Partnering with internal stakeholders on establishing safety strategies for NDAs, commercialization and post-market pharmacovigilance requirements.
  • Represent PV and Safety Risk Management Department, as applicable
  • Management and mentoring of the Safety Scientist(s) and Medical Reviewer(s) supporting the assigned product(s)
  • Under the direction/review of Head of PV, participate in other PV and Safety Risk Management activities as necessary

What is Required

  • Minimum of a PharmD, MD, DO, or NP with at least 10 years of experience in international PV with relevant clinical experience considered
  • Hire, manage and mentor safety scientist(s) and medical reviewer(s) responsible for assigned product(s)
  • Must have led PV strategy and activities for a compound including the preparation of DSURs, PSURs, Company Core Safety Information (CCSI) and Risk Management Plans
  • Experience with the identification and evaluation of safety signals through the assessment of individual case safety reports and aggregate data summaries from clinical studies and post marketing experience
  • Clinical development and post marketing experience required including establishment of strategies, priorities for PV activities
  • Thorough knowledge of current US, Global, and ICH safety management and reporting regulations and guidelines
  • Worked with a drug safety database (ARGUS experience helpful) and have had responsibility for medical review of SAE reports
  • Strong working knowledge of MedDRA and WHODrug coding dictionaries
  • Excellent written and oral communication skills in the English language
  • Ability to perform and present Safety Analyses to Senior Management and prepare presentations for Board of Director meetings
  • Resourcefulness and personal organization skills together with demonstrated cross-functional teamwork
  • Competent in Microsoft Word, PowerPoint, Excel
  • Ability to maintain an “inspection ready” environment
  • Strong attention to detail
  • Solid medical knowledge of methods to assess causality relationship between adverse events and investigational and marketed products
  • Relevant experience in the oncology therapeutic area, strongly preferred

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.

1726049

Your Responsibilities

  • In collaboration with the Medical Director, leads development of study protocol and amendments
  • Routinely reviews clinical study data, querying discrepant data points to ensure accurate data reporting and significant focus on data quality
  • Supports medical monitoring and reporting, evaluates clinical trial adverse events, reviews clinical laboratory results
  • 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 AE section of ICF templates, eCRFs and SAE report forms
  • Ensures consistency across studies
  • Collaborates with the clinical development team on analysis and interpretation of study results
  • Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update 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
  • 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
  • Contributes to clinical study report content
  • Assists with preparing responses to questions from Health Authorities and Ethics Committees
  • Supports general Clinical/Medical Affairs activities involving product evaluation, labeling & surveillance
  • 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 degree in a scientific discipline, minimum of master’s degree; PhD, MD, PharmD, DO preferred
  • 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

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.

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.

Your Responsibilities:

  • 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.

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