1651230

Job Description Summary

This leadership position will be responsible for developing and implementing strategies to support systems integration enhancements for clinical trials. This role requires strategic orientation and functional expertise to lead the team and to develop new approaches to streamline clinical trial processes and conduct. This role will be the single point of accountability for robust clinical trial feasibility and use of analytics to drive and optimize site selection, a vertically integrated organization of dedicated study start-up professionals, vendor management, support of external collaborations, and other functions to facilitate increased operational efficiency. The role will establish the vision and build the framework to support the integration of novel enhancements and analogs to improve clinical trial performance and KPIs. You will develop, implement, and continuously enhance clinical research processes and capabilities to improve the quality and execution of Mirati’s clinical trials. You will play a critical role in the success of Mirati’s strategy to improve efficiencies and enable enhanced process capabilities for the delivery of clinical trials. You will partner with multiple internal groups within Integrative Sciences, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical Operations, and Medical Affairs and work cross-functionally with other leaders to ensure systems integration standards meet business needs and objectives as well as regulatory standards.

Your Responsibilities

  • Lead organization in the delivery of high-quality process and operational excellence for clinical trials
  • Establish trial site feasibility and selection processes using advanced analytics and predictive models
  • Lead development of clinical and operational data-driven feasibility estimates, benchmarking assumptions, validated scenarios & accurate planning
  • Develop and optimize processes and procedures for vendor management, clinical trial feasibility, study start-up activities, external collaborations, and clinical trial event management
  • Develop and integrate new technologies, systems, and tools to enhance clinical trial conduct and overall performance
  • Monitor benchmarks with industry peers and across other industries to establish and update best practices and KPIs
  • Partner with CROs, Clinical Operations and Program Management to develop and deliver rapid, accurate, and robust assessments of program and country feasibility, oversight of site identification/site feasibility, and timing of key start-up and recruitment milestones
  • Ensure appropriate communication and involvement across functions to create clear accountability for high quality, multidisciplinary processes
  • Recognize and implement efficiencies identified through process improvements

What is Required

  • Master’s Degree in a scientific discipline. Doctorate degree preferred.
  • At least 15 years of experience in biotech, CRO, academia, or pharmaceutical industry-leading oncology clinical trials
  • Strong background showing progressive clinical trial and clinical development experience, including staff management
  • Demonstrated experience with improving clinical trial KPIs
  • Previous clinical trial outsourcing and associated governance leadership experience
  • Ability to develop new clinical trial strategies using technology and systems (i.e. site feasibility, RWD, analytics etc.)
  • Leadership and or staff experience in a study start up unit and/ or feasibility center of excellence preferred
  • Strong written/verbal communication skills, detail-oriented nature
  • Excellent leadership and influencing skills
  • Demonstrated project management skills
  • Ability to provide direction with cross-functional teams in a matrixed team environment
  • Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook)

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.

1724973

Job Description Summary

The Clinical Operations Study Lead will lead study operational strategy and planning, and oversee execution of clinical studies for assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan

  • Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Mirati SOPs), on schedule and on budget
  • Lead, direct and oversee CROs and other 3rd party vendors to achieve project goals

Your Responsibilities

Leading Operational Strategy, Planning and Execution of assigned Clinical Trials

  • Provides leadership, direction and oversight to CRO and 3rd party vendors to ensure study is progressing per plan and study issues are addressed and brought to resolution
  • Develops Operational Strategy with a focus on ensuring accurate assumptions are applied and robust risk management plans are in place, and periodically updated during the life of the study
  • Leads cross functional Study Team Meeting
  • Single point of operational accountability for entire study lifecycle from protocol synopsis to CSR
  • Presents at Quarterly Reviews with CRO and Mirati Leadership reviewing performance against metrics and other key performance indicators (KPIs)
  • Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents
  • Ensures operational feasibility, patient and site, is conducted
  • Contributes to CRO selection; Ensures CRO/3rd party vendors are appropriately onboarded, trained and qualified
  • Participates in country and site feasibility/selection process, with a focus on providing country operational insights, corporate alignment and therapeutic expertise to ensure alignment between study execution plan and program strategy
  • Accountable for study budget planning and management
  • Validates study budget and ensures impacts are adequately addressed
    • Provides alternative options/offsets in the case of significant budget increases
  • Routinely communicates study status, issues and mitigation plans to manager and project team

CRO OVERSIGHT:

  • Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
  • Review, endorsement and validation of relevant study plans and timelines
  • Attendance at CRO-led study meetings; Drive agenda topics and review meeting minutes for accuracy and compliance
  • Review of outcomes/actions related to protocol deviations; primary purpose of review is to support the identification of trends across sites and/or the study
  • Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
  • In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the operational plan for database lock and CSR
  • Ensure studies are “inspection ready” at all times; May be involved in regulatory inspections by preparing for and/or attending the inspections

What is Required

  • Bachelor’s degree in one of the disciplines related to drug development or business required; Advanced degree desirable
  • Minimum 8 years of relevant experience
  • Broad experience in a Clinical Trial discipline executing all phases of a study from protocol synopsis to CSR
  • Demonstrated project management and cross-functional team leadership experience
  • Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget
  • Strategic thinking and targeted problem-solving skills
  • Ability to identify, resolve & escalate issues
  • Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery
  • Ability to represent & communicate clearly to senior leaders, governance and external bodies
  • Strong communication and interpersonal skills

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.

1739185

Job Description Summary

This management position will be responsible for developing and implementing strategies and operational methods to optimize clinical trial initiation processes. This role requires functional expertise leading an internal team to develop new approaches to streamline clinical trial processes and conduct in partnership with CROs. This role will be the single point of accountability for study start up and also the operations lead for networks and alliances. The role will establish and build the framework to support integration of novel enhancements and analogs to improve clinical trial start up performance and KPIs. You will partner with multiple internal groups within Integrative Sciences, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical Operations and Medical Affairs and work cross functionally with other leaders to ensure systems standards meet business needs and objectives as well as regulatory standards.

Your Responsibilities

  • Accountable for strategic and operational optimization of a portfolio of clinical studies with primary focus on the study concept and initiation phase
  • Directly manage internal Study Start Up Associates working with CROs and sites to optimize and streamline trial initiation and site activation timelines
  • Lead and drive specific study strategy in interactions with Site Networks and Alliances, hospital or university clinical research units, advocacy groups, and recruitment vendors
  • Contribute to protocol timeline planning activities, feasibility assessment and recruitment and retention support
  • For Site Networks/Alliances, work closely with internal team members including those managing the relationship, to advance joint goals and deliverables and promote overall health and success of the collaboration which includes but is not limited to:
    • Study start up elements
    • Adherence to unique operating models of networks/alliances including just in time models
    • Management of operational escalations
    • Data aggregation and reporting for accrual tracking, network/alliance KPIs and more
    • Support internal teams with visibility to the alliance model, unique aspects and development of new processes as needed while ensuring internal alignment
    • Interface closely with medical affairs on the aspects of the network relationship and with the partner as needed
    • Ensure that network alliances are managed consistently, drive implementation of alliance management best practices, standard tools and approaches where feasible
  • Responsible for driving continuous improvement of study start up processes, functions and deliverables within Trial Optimization; May serve as Process Owner
  • Establishes performance metrics for his/her teams and monitors these metrics in an effort to continually enhance capabilities and improve overall quality and timelines
  • Manages resources to ensure portfolio needs are appropriately supported and study start up workload is balanced
  • Provide vision, leadership, oversight, mentoring and coaching to Study Start Up Associates

What is Required

  • Bachelor or Master of Science degree in medical/pharmaceutical/biological discipline
  • At least 8-10 years of experience in the conduct of clinical trials and expertise in business process analytics and continuous improvement
  • Direct experience in leading and managing oncology clinical trials, and in accelerating clinical study start up
  • Demonstrated experience optimizing workflows involved in site selection, IRB/IEC submissions/approvals, site essential document processing, contract and budget negotiations, and enrollment
  • Experience directly leading an organization and or colleagues in the same discipline
  • Demonstrated expertise in designing and implementing measurable mitigations throughout the life of a clinical trial, and specifically in the study start up arena
  • In depth knowledge of regulatory guidelines and ICH/GCP
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Demonstrated project management and cross-functional team leadership experience
  • Strategic thinking and targeted problem-solving skills

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.

1706746

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.

Job Summary:

The Clinical Trial Manager (CTM) provides trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions). This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans.

Your Responsibilities:

  • Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs.
  • Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
  • Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
  • Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
  • Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
  • Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Supports financial management of the study which includes review and approval of site and vendor invoices.
  • Supports risk Management initiatives.
  • Supports audit/inspection activities as needed.
  • Maintain clinical trial registry entry/updates, as required.
  • Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.

What is Required:

  • BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.
  • 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international.
  • 3-5 years study oversight as an in-house CTM (e.g., CRO/vendor oversight)
  • Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
  • Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines.
  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Demonstrated ability to mentor/lead.
  • Hands on knowledge of Good Documentation Practices.
  • Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas.
  • Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
  • Ability to understand and analyze data/metrics and act appropriately.
  • Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
  • High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
  • Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships.
  • Works with high quality and compliance mindset.

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.

1672281

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.

Job Summary:

The Clinical Trial Manager (CTM) provides trial operational oversight of CROs and vendors (including both U.S. and Ex-U.S. regions). This role also assures adherence to GCP, regulations and applicable procedures, in addition to protocol compliance and that of study related plans.

Your Responsibilities:

  • Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs.
  • Develops strong vendor and site relationships and ensures continuity of relationships through all phases of the trial.
  • Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
  • Coordinates & manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure.
  • Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
  • Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines.
  • Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met.
  • Supports financial management of the study which includes review and approval of site and vendor invoices.
  • Supports risk Management initiatives.
  • Supports audit/inspection activities as needed.
  • Maintain clinical trial registry entry/updates, as required.
  • Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.

What is Required:

  • BA/BS in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered.
  • 5 years of direct site management (monitoring) experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international.
  • 3-5 years study oversight as an in-house CTM (e.g., CRO/vendor oversight)
  • Experience in running a trial from start to finish; initiating the trail that includes protocol writing, ICF generation, site feasibility/start up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close out.
  • Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
  • Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines.
  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Demonstrated ability to mentor/lead.
  • Hands on knowledge of Good Documentation Practices.
  • Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas.
  • Strong IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
  • Ability to understand and analyze data/metrics and act appropriately.
  • Possesses effective time management, organizational and interpersonal skills, conflict management, problem-solving skills.
  • High sense of accountability/urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
  • Works effectively in a matrix cross-functional environment. Ability to establish and maintain culturally sensitive working relationships.
  • Works with high quality and compliance mindset.

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 Cookies on This Site

This website uses cookies. Essential and functional cookies are necessary for the proper functioning of this website and cannot be refused. Other cookies are used for statistical purposes and will only be placed if you agree to their placement. For further details on cookies, how we use cookies and how to modify your choices regarding cookies, please read our Cookies Policy.