Sr Manager, Medical Information

The Sr. Manager, Medical Information will work on a high-performing team responsible for medical content development and reviews, as well as maintaining a repository of documents in Veeva for Mirati Therapeutics. This is a key individual position within the Medical Affairs organization that will ensure professional standing and integrity with patients, healthcare providers, and the pharmaceutical industry through high-quality and aligned medical content deliverables. The team member in this position will generate key medical content, as well as AMCP dossier, and communication and evidence submissions to key guidelines/compendiums and clinical pathways. Additionally, this individual will play a key role in reviewing medical accuracy and content during promotional review at medical-legal-regulatory committee meetings and review of medical material. Furthermore, this individual will provide coordination and support to various medical congress-related activities.

Your Responsibilities

The Sr. Manager, Medical Information will be a key member of the Medical Capabilities and Operations team that will lead the planning, development, and deployment of scientific content to Medical Affairs and work with cross-functional partners in medical and promotional reviews. Key responsibilities include, but not limited to:

  • Provide support to key medical information-related activities 

  • Review and develop medical materials and scientific content (i.e., medical slide decks, digital and enduring content) relevant to Mirati’s product(s) and therapeutic areas of focus

  • Serve as a key medical reviewer and provide medical and scientific input to the promotional and medical review committees

  • Support the development of the AMCP dossier with scientific data input and medical reviews

  • Responsible for submission of evidence and other required materials to key guidelines/compendium and clinical pathways for treatment listing considerations at time of product launch or new data publication; monitor for uptakes/updates and identify areas that need additional information and plan of engagement with compendium personnel

  • Support the development of key medical affairs training materials as needed

  • Provide medical support at medical conferences with activities including medical booth coverage/staffing and conference material review, etc.

  • Support the creation and implementation of policies, SOPs and work instructions governing the operations related to the Medical Content function (i.e., promotion and medical reviews, Data on File) that meet all compliance standards and regulations

  • Provide strategic direction and oversight with regards to the quality of the deliverables from vendors

  • Other duties as assigned

What is Required

  • Advanced degree in life sciences; Oncology experience preferred

  • 2+ years in medical affairs with experience in medical information / promotional review

  • Knowledge of industry compliance and regulatory environment

  • Strong sense of accountability and track record of execution and operational effectiveness

  • Ability to understand and communicate scientific data

  • Team orientated and ability to work collaboratively towards common objectives

  • Ability to influence externally and internally

  • Being based or relocation to San Diego is preferred but not required; if remote, routine travel to the home office in San Diego may be required

  • Additional travel may be required up to 10% of your time

Pay Disclosure

Salary Range:

$150,000.00 – $195,000.00

The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).

Total Rewards:

Mirati employees (and their families) are provided a competitive benefits package including:

  • Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision

  • Company provided life insurance and disability coverage

  • 401(k) retirement plan with a 6% company match and immediate vesting

  • Employee Stock Purchase Plan with a 15% discount

  • Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter

Sr. Paralegal, IP

Job Description Summary

Mirati is seeking an experienced paralegal to assist with our day-to-day intellectual property and contracting needs. The ideal candidate should have significant experience assisting in the generation and filing of patent and trademark applications and related documents, docketing and facilitating patent and trademark workflow, and working with in-house and outside IP counsel to develop high-quality patents and trademarks. The ideal candidate should also have significant experience drafting, negotiating, and managing a variety of agreements for pharmaceutical and life sciences companies, including clinical trial agreements, non-disclosure agreements, master services agreements and consulting agreements. The successful candidate must be able to work independently to draft, revise and negotiate agreements, with a flexible and collaborative approach.

Your Responsibilities

  • Docket patent- and trademark-related correspondence. Generate docket reports using docketing software. Review docket reports to ensure timely provision of instructions to US and foreign agents.
  • Interact with in-house IP counsel, outside US and foreign patent counsel, and partners’ patent counsel to facilitate smooth, accurate and prompt handling of patent and trademark matters.
  • Assist in drafting/assembly/execution of patent applications and patent prosecution documents, including formal papers (assignments, declarations).
  • Draft, review and negotiate day-to-day contracts, including non-disclosure agreements, master service agreements, consulting agreements, clinical trial agreements and other clinical documents, independently and with limited supervision.
  • Manage contract negotiations to conclude agreements as efficiently as possible while meeting client needs and safeguarding Mirati’s interests.
  • Review and comment on IP terms in a broad array of agreements.
  • Address legal concerns of business groups across the company and coordinate cross-functionally with business groups including finance/accounting, clinical science, medical affairs and research.
  • Complete projects and special assignments, as needed.

What is Required

  • At least 8 years’ experience as a paralegal in the pharmaceutical, life sciences or biotechnology industry, and/or law firms servicing those industries.
  • Paralegal certification preferred; California notary preferred.
  • Experience in MS Office product suite (Excel, PowerPoint, WORD, VISIO), Adobe and DocuSign, and contract management systems (Agiloft preferred).
  • Strong knowledge of patent and trademark prosecution workflow and processes.
  • Experience in patent and trademark docketing procedures, and related software.
  • Familiarity with clinical research process.
  • Capable of reviewing complex agreements, with an understanding of when to escalate sensitive areas or issues for further consideration or specialist review.
  • Ability to be productive and successful in a fast-paced work environment.
  • Self-directed, self-motivated and detail-oriented nature; willing to proactively assume responsibility for and consistently follow through on assignments.
  • Demonstrate honesty, dedication, cooperation, positive attitude, adaptability and flexibility with changes in responsibilities and duties.
  • Bachelor’s degree or Associate’s degree 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 KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

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.

Medical Director

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.

#LI-Remote

Associate Director, SEC Reporting & Technical Accounting (Remote)

Job Description Summary

The Associate Director, SEC Reporting & Technical Accounting will oversee the SEC reporting function, technical accounting research and positions, and SOX compliance of Mirati Therapeutics, Inc. (the “Company”). This role will require a deep understanding of U.S. GAAP, SEC guidance and SOX 404 requirements, strong analytical skills, written and verbal communication skills, and an ability to develop relationships and work cross-functionally. The ideal candidate is highly motivated, detail-oriented, and can help identify and develop best processes and practices to help support growth of our team and the Company.

Your Responsibilities

  • Plan, coordinate and execute all external, SEC financial reporting processes and initiatives, including related activities such as:
    • prepare annual, quarterly and periodic reports (i.e., 10-K, 10-Q and 8-K), and coordinate reviews and lead meeting discussions over such documents with the Executive Leadership Team, Disclosure Committee, Audit Committee, and external auditors
    • prepare the Company’s annual proxy statement, including the related directors’ and officers’ questionnaires, ensuring compliance with all disclosure requirements and coordinating the annual meeting of shareholders
    • prepare financial analyses and ad-hoc materials for audit committee and board of director meetings
  • Perform technical accounting research around new accounting standards and complex accounting issues, and prepare technical memorandums to support the Company’s positions
  • Key team member for first time commercial launch biotech company, evaluating accounting standards, disclosures, and our internal control environment for product sales, inventory, and gross-to-net considerations
  • Lead SOX 404b compliance efforts, by designing and implementing new internal controls as needed, monitoring ongoing performance and compliance of the Company’s SOX procedures, ensuring appropriate documentation (narratives, risk assessments, testing results etc.), and identifying exceptions and conducting remediation efforts as needed.
  • Coordinate directly with external auditors and facilitate quarterly review and year-end audit procedures
  • Proactively strive for process improvements to enhance financial reporting processes and implement best practices
  • Assist with monthly accounting close duties, as needed
  • Lead other special projects as required, and other duties to support the finance function

What is Required

  • 10+ years of accounting experience; combination of public accounting / life sciences industry experience is ideal.
  • CPA Required
  • Experience with Workiva, Active Disclosure, or other financial reporting platform
  • Experience working in a SOX 404(b) compliant environment
  • Substantial experience with and knowledge over U.S. GAAP, SEC guidance and SOX 404 requirements
  • Experience at a commercial biotechnology company is a plus
  • Strong time management and organizational skills
  • High degree of attention to detail
  • Strong written and verbal communication skills
  • Ability to work independently and prioritize tasks

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.

#LI-Remote

Director, Compliance (Remote or Office Based)

Job Description Summary

The Director, Compliance will assist with the development and implementation of a healthcare compliance program at Mirati, including being responsible for the implementation of systems, programs, processes, and practices to ensure that the Company is in compliance with legal and regulatory requirements and its policies. The Director, Compliance will provide a broad range of compliance support throughout Mirati’s organization; partnering with the business to sustain Mirati’s ethical and compliant culture and develop practical ways to uphold the legal, regulatory, and ethical obligations of a pharmaceutical company

Your Responsibilities

  • Independently drive the development, implementation, and management of the compliance program, including policy, process, training, communication, auditing, monitoring, and investigations
  • Lead and manage all compliance operations activities including providing compliance oversight and participating, as required, in review and approval processes for core Commercial and Medical activities: grants, sponsorships, speaker bureau, advisory boards and other initiatives involving interactions with healthcare professionals, healthcare organizations and patients/advocacy groups.
  • Develop and be responsible for oversight of the company’s compliance auditing and monitoring program; including:
    • Assessing organizational compliance risk in creating and updating a risk-based audit and monitoring plan. Partnering with the business to address detected noncompliance including recommending and taking corrective actions when needed
    • Track and report results of compliance investigations and the corrective actions taken to Compliance leadership and other internal key stakeholders as needed. Interpret findings/trends and carry out corrective action and retraining as needed
  • Develop and oversee a comprehensive compliance training program and communication strategy to U.S. employees and designated third parties on applicable compliance policies, laws and regulations, including any new developments or updates that may impact the Company’s compliance program.
  • Create and lead the transparency reporting program, including developing, reviewing, and submitting reports related to federal and state transparency (“Sunshine”) laws.
  • Monitor the business developments and industry compliance best practices to evolve the compliance program through ensuring appropriate practices, processes, systems and tools are in place and maintained to support the business at all times.
  • Be an ambassador for communication around key compliance topics, resources, and special initiatives

What is Required

  • Bachelor’s degree and 10 years’ experience or any combination of education and experience providing equivalent background.
  • Certification in Healthcare Compliance (CHC) preferred
  • Working knowledge and previous experience in a compliance operations or project management position desired
  • Excellent interpersonal, communication and written skills, proven ability to work independently with a wide range of stakeholders.
  • Strong presentation and training skills and ability to work independently.
  • Interact with employees and manage vendors
  • Up to 20% travel may be required.
  • Role will be remote.

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.

#LI-Remote

Sr. Manager, FP&A – Supporting Clinical Operations (Remote)

Job Description Summary

The Sr Manager, FP&A will be a Finance Business Partner between Finance and the Clinical Operations Teams. This position will drive financial planning and forecasting by working cross-functionally to support our clinical studies and major business initiatives. The role will focus on the analytics that support budgets, forecasting, financial reporting and program management. The Sr Manager, FP&A will be a hands-on resource to senior management, clinical operations department heads and program leads.

Your Responsibilities

  • Develop and coordinate financial budgets and forecasts for the organization.
  • Participate in the budgeting/forecasting process; includes owning financial reporting in partnership with Program Team Leaders, Program Team Members and Clinical Operations Department Heads. Thus, ensuring financial information (budget vs actual) and other key performance indicators are provided on a monthly basis in order to effectively manage the active programs and the business as a whole.
  • Ensure all key topics are raised proactively and aligned with stakeholders to minimize surprises.
  • Prepare monthly reporting packages that include full financial statements, key performance indicators, key business trends, actual vs budget/forecast variances and comprehensive explanations of key differences for assigned functional areas.
  • Work closely with Clinical Operations Department Heads to perform budget re-forecasting on an as required basis.
  • Work closely with Clinical Operations Department Heads to develop and review customized financial reporting to support clinical trials and associated activities.
  • Develop financial models and productivity tools to help make responsible financial decisions. Recommend enhancements to the financial planning and budgeting process and system that effectively generate program and activity-based reporting to meet internal business and SEC reporting requirements.
  • Provide accounting support in connection with the monthly close process and coordinate with Accounting to drive Balance Sheet and P&L accuracy and control.
  • Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

What is Required

  • Bachelor’s degree in Finance, Accounting, Business Administration or science-related field (Master’s Degree or CPA Preferred).
  • 7+ years of relevant experience.
  • Proven experience utilizing advanced Excel skills to interpret large amounts of data.
  • Financial Planning systems knowledge; Adaptive Insights preferred.
  • Experience providing financial support in the biotechnology/pharmaceutical industries, specifically supporting clinical operations
  • Understanding of GAAP and key accounting principles.
  • Excellent interpersonal skills, along with the ability to work effectively with multiple functional areas in a collaborative, team environment.
  • Strong verbal and written communication skills.
  • Ability to thrive in a fast-paced ever-changing environment.
  • Alignment with Mirati’s culture and values.

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

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.

Sr. Programmer, Statistical Programming

Job Description Summary

As Sr. Programmer, Statistical Programming you will lead programming support for multiple complex oncology studies in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, and validate SAS® programs in accordance with company, industry, and regulatory requirements; you will play a key role in developing, implementing and evaluating statistical programming standards and processes

Your Responsibilities

  • Lead programming support for multiple complex oncology studies, provide input to timeline development, and resource assessment
  • Create/review programming plan, specifications for datasets and TLFs. Advanced knowledge with CDISC conventions, i.e., SDTM and ADaM models and experienced in implementing these models
  • Develop and validate SAS® programs to produce high quality deliverables for in-house projects within set timelines in accordance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures
  • Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/implement solutions to identified issues; ensure datasets are in compliance with submission standards
  • Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
  • Lead the creation and review of analysis file specification for ISS and ISE; program and validate ISS and ISE
  • Having advanced level of programming expertise, create and validate SAS macros and utilities to automate standard and frequent tasks
  • Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements
  • Review and provide input on documents produced by other Biometric functions such as: statistical analysis plans; TFL shells; data management plans; data transfer plans and case report forms
  • Contribute to the development, implementation and continuous improvement of programming processes and standard
  • Effectively communicate in a project team environment, within department, among functional groups and external collaborators
  • Perform other programming duties as assigned

What is Required

  • Minimum of BS required in Computer Science, Statistics, Life Sciences or other related field
  • BS with 6+ years or MS with 4+ years of SAS programming experience in drug development in CRO or pharma/biotech company
  • Good written and verbal communication skills
  • Oncology experience preferred, and submission experience 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 KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

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.

#LI- Remote

Sr Cloud Systems Administrator

Job Description Summary

Mirati is seeking an Sr. Cloud Systems Administrator who has extensive experience working with Microsoft’s Azure platform and enterprise application services to support the IT leadership team in executing the roadmap for IT infrastructure and cloud operations. This role’s primary focus is on ensuring technology resources are distributed, maintained, secured, configured, and effectively utilized across Mirati’s growing network.

This is a technical role that requires hands-on knowledge of different areas within the cloud arena such as user management, authentication (e.g. Okta, Azure MFA), orchestrate VDIs Linux/Window/Images, cloud enterprise collaboration tools (Teams, SharePoint, OneDrive, Power Platform), cloud infrastructure architecture on AWS and Azure, scripting (PowerShell, bash, Azure cli), cloud and on-premise storage, backups, device management platforms (e.g Intune, Business Manager, Airwatch ), reporting, metric analysis, and familiarity with networking and wireless.

The ideal candidate will be passionate about information technology (IT) operations, providing reliable and secure infrastructure and networking platforms in support of Mirati’s critical business solutions. They should have an excellent ability to communicate, organize, document, and solve problems using their in-depth understanding of information systems. They will also be able to use their technical experience and business acumen to maintain a trusted relationship with end-users and business partners, while enabling technical teams to deliver and maintain quality solutions aligned with Mirati’s organizational goals.

Your Responsibilities

  • Troubleshoot and document deployment and system issues
  • Follow-up on alerts and notifications
  • Responsible for performance metrics, analysis, and uptime
  • Configure, secure, and maintain Infrastructure as a Service (IaaS)
  • Provide technical support to Mirati’s end-users’ through our ticketing system
  • Write and document code/instructions to automate system architectures
  • Working on custom special projects as assigned
  • Work with the Network Administrator to document, maintain and support networking efforts
  • Understands Azure platform and architecture, documents, and supports the underlying business processes, workflows, data and application platforms that depends on Microsoft and 3rd party services
  • Take ownership of issues, with a sense of urgency, and using sound judgment to resolve
  • SQL server maintenance and support
  • Firewall maintenance and support
  • Server documentation, installation, support, maintenance
  • Backup documentation and maintenance
  • Responsible for tracking licenses, metrics, and reporting
  • Engage peers in accordance with processes and procedures to document and contribute to solution/architecture designs

What is Required

  • Minimum 4 years’ experience in a similar role
  • The ability to communicate to technical teams as well as non-technical resources.
  • Strong working knowledge of Azure’s platform (M365, Exchange Online, SharePoint, Teams, Azure Active Directory, Power platform, SAML, Defender, SQL databases, Azure Storage, Virtual Network, VPN and Gateways, Powershell/Azure Cli); knowledge of Security and Compliance Center highly desired.
  • Strong knowledge of Azure/AWS infrastructure and architecture
  • Experience with the implementation, integration, management, and support of hybrid environments where SaaS, PaaS, and IaaS solutions, and virtualized and cloud-based infrastructure, are incorporated as required.
  • Strong working knowledge and proven working experience with the following: Windows, Linux, Unix, Storage, VDI, Active Directory, VMware, AWS, Azure, and hardware such as Dell and Cisco/Meraki.
  • Sound technical skills in networking (DNS, DHCP, remote user support, etc.) and experience with circuits, routers, switches, and ISP responsibilities and relationships.
  • Experience in the pharmaceutical industry is highly desirable.
  • Strong detail and organized documentation/technical writing
  • Strong verbal communication skills
  • Has a strong understanding and competency in IAM, resource monitoring and resource groups, mapping dependencies, and scripting

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.

#LI-Hybrid

Principal Scientist, Product Development

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?

The Principal Scientist, Product Development will be responsible for design and development of small molecule oral solid dosage drug products for different phases of clinical studies and commercialization. He/she will serve as a subject matter expert in product development related activities for new product introductions, and product lifecycle. He/she will provide technical expertise towards formulation, process development, scale-up and tech-transfer activities conducted in-house and at external contract development & manufacturing organizations (CDMO’s). He/she will work effectively with cross-functional groups, including analytical development, process chemistry, clinical, quality, regulatory, and supply chain to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures (GLP, GMP, ICH).

Your Responsibilities:

  • Design and develop optimal formulations, and robust, scalable and cost-effective processes for the manufacture of drug products for clinical studies and commercialization. Design and implement efficient DOE’s to support formulation and process robustness.
  • Support material characterization efforts such as solid state form, mechanical attributes, particle size assessment, and physicochemical stability. Collaborate effectively with API process chemistry group to ensure drug substance with optimal physico-chemical properties is advanced towards commercialization.
  • Support preclinical team in the production of optimal formulations and preparation procedures for toxicology and DMPK studies. Provide technical inputs for clinical dosage form bridging strategies and to manage potential scale-up and post-approval changes.
  • Lead screening, selecting, and managing drug product manufacturing sites/technologies (CDMOs) of oral solid dosage drug products.
  • Lead process scale-up and tech-transfer of various pharmaceutical unit operations using Quality by Design (QbD) elements such as FMEA, Design of Experiments (DoEs), statistical analysis, first principles, and process modeling.
  • Late stage drug product Subject Matter Expert for oral solid dosage forms, providing technical direction during drug product development at Mirati R&D lab and at CDMOs.
  • Author / review manufacturing batch records and study protocols. Author / coordinate preparation of high-quality technical reports and integrated project summaries.
  • Author/ review CMC regulatory documentation for IND, IMPD, NDA, and MAA filings, covering all phases of clinical development and commercial launch. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
  • Support design of primary, secondary, and tertiary packaging/labeling solutions for drug products. Support related activities for qualification and validation in collaboration with supply chain and quality functions.
  • Lead drug product post-launch assessments such as Continued Process Verification (CPV) and Continuous Process Improvement (CPI) by utilizing technological innovation and Lean Six Sigma methodologies.
  • Build strong relationships with contract manufacturing partners, contract manufacturing Quality, and drug product manufacturing process technical teams. Support evaluation of product impact from manufacturing processes, production scale, equipment, and raw material changes.
  • Maintain up-to date scientific knowledge of pharmaceutical process engineering through regular literature review and participation in conferences/industry consortium to keep Mirati at the forefront of manufacturing best practices, technology trends and innovative solutions.

What is Required:

  • Relevant degree in Chemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Industrial Pharmacy, or other life sciences related fields to include: Doctorate (Ph.D.) with 8+, Masters (M.S.) with 12+, or Bachelor (B.S.) with 15+ years of experience in Pharmaceutical industry.
  • Technical expertise in formulation design, process development, process scale-up and technology transfer of conventional and enabling solid oral dosage forms using FDA/ICH guidance and Quality by Design (QbD) principles such as DoE, statistical analysis, first principles, modeling, and FMEA/Risk Assessment tools.
  • Strong knowledge and hands-on experiences in conventional and enabling oral dose manufacturing unit operations such as: Dry/Wet Granulation, Milling, Blending, Compression, Film Coating, Spray Drying, Nano-Milling, and Twin Screw Extrusion.
  • Robust understanding of material science and linkage to manufacturing process and product performance. Experience in use of applied science during manufacturing troubleshooting, gap analysis, root cause analysis, and risk assessment.
  • Experience in authoring CMC sections of regulatory dossiers (including NDAs and MAAs) with proven track record. Knowledge of cGMP requirement for drug product development and manufacturing.
  • Hands-on experience in Process Validation (PPQ), and post approval changes according to FDA and ISPE guidelines. Experience in use of statistical tools in data trending for process performance characterization, process capability analysis, and CPV/CPI during product life cycle.
  • Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the company. Experience in project management and ability to work in a cross-functional working groups.
  • Excellent verbal and written communication skills with strong technical report writing.
  • Ability to travel up to 35% domestically and internationally.

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.

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRASG12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRASG12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

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.

#LI-Hybrid