1719411

Job Description Summary

The Senior Manager, CMC Project Management will manage and support Technical Operations projects covering multiple functional areas, including, but not limited to, Clinical and Commercial Manufacturing, Process Development, Analytical Development and Control, Technology Transfer, Validation, CMC Support of Regulatory Filings, and CMC Alliance Management.

Your Responsibilities

  • Support the implementation of assigned Technical Operations projects from initiation to implementation
  • Prepare and maintain overall project timeline and provide appropriate benchmarking and risk management information
  • Ensure functional leads have clearly defined project scopes, deliverables and timelines
  • Work with functional leads to ensure that project priorities are clearly documented
  • Follow up on issues, actions and risks to program
  • Apply objective and rational, critical thinking and seek to identify contingency and mitigation plans and enlists key people to resolve obstacles to expedite drug development process through all phases
  • Collect, consolidate and analyze project plans and information across projects
  • Prepare development scenario plans to support decision-making and budgeting process
  • Develop, in conjunction with project team, yearly strategic program and development plans and annual budgets
  • Support overall team function and team leaders in their strategic function
  • Coordinate sub-team activities as required and act as the central core of project team information; ensure activity owners are completing assigned project tasks
  • Maintain primary responsibility for project team meetings, including scheduling, preparation of agendas and minutes, and action items
  • Serve as primary CMC project management contact for business alliances and ensure clear and effective communication across the alliance
  • Develop effective and accurate project metrics reporting criteria and standards
  • Prepare monthly, quarterly and other ad hoc presentations and status reports for Senior Management
  • Conduct reviews (e.g., risk or issue reviews, team evaluations, project post-mortems)
  • Act independently to determine methods and procedures on special assignments

What is Required

Leadership Attributes

  • Must possess exceptional organizational and communication skills
  • Strong interpersonal skills and business acumen, excellence in building and managing relationships, ability to understand all perspectives, find common ground and effectively bridge significant differences
  • Detail-oriented while also retaining the ability to see the big picture
  • Demonstrated problem solving skills with strong business skills/acumen
  • Proven ability to manage multiple projects, set priorities and meet deadlines
  • Experience working on cross-functional teams to accomplish shared goals

Education/Skills

  • BS or BA in Science or Engineering required; an advanced degree or PMP certification preferred
  • 7+ years of experience in pharmaceutical/biotechnology development area, including first-hand understanding of drug development process
  • Solid understanding of clinical manufacturing, process development, analytical development and control, technology transfer, validation, and CMC support of regulatory filings.
  • Experience in project management in global pharmaceutical drug development
  • Proven skills to independently manage and influence multiple project activities and plans simultaneously; direct management of at least one complex program
  • Significant experience operating in a virtual business model
  • Knowledge of ISO, Quality Systems and work in an FDA regulated industry
  • Experience with planning, procurement, forecasting, logistics and customer service
  • Proficiency / experience with the use of Microsoft Project, Excel, Word and Power Point is required
  • Strong analytical, interpersonal, leadership and communications skills
  • Proven ability to lead cross-functional project teams globally, to manage by influence and to work with diverse teams
  • Expertise in decision analysis and conflict resolution
  • This position may require approximately 10-20 percent travel, domestic and international

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.

1732071

Job Description Summary

The Clinical Programmer is responsible for programming and providing complex data listings and reports in SAS to support data review activities across multiple clinical studies. This individual will collaborate with Biometrics, Clinical Science, Medical, and Clinical Safety and Contract Research Organizations (CROs) for development of data review listings and patient profiles. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.

Your Responsibilities

  • Perform SAS programming of complex listings/reports to support Data Management data review.
  • Program data listings checks as necessary to facilitate Data Management’s data cleaning activities.
  • Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities and usage by Data Management, Clinical, and Medical for data review, as appropriate.
  • Write SAS tools and develop generic SAS programs for clinical studies, as appropriate.
  • Develop programs for patient profiles and/or ad hoc reports for data review.
  • Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation.
  • Proactively identifies potential study issues/risks and recommends/implements solutions.
  • Provide programming support to Statisticians and Statistical Programmers as needed.
  • May be involved in other data management related activities including but not limited to management of documents (data management plan, CRF completion guideline, database specifications), and performs User Acceptance Testing.

What is Required

  • Strong SAS programming skills required, with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS SQL.
  • 5+ years of experience in programming with clinical trial data and preparing programming and validation documentation in the CRO and/or other data management activities in the pharmaceutical or biotechnology industry.
  • Extensive experience of handling external data, such as lab data, PK, ECG, Imaging, etc.
  • Knowledge of industry standards (CDISC, SDTM), 21 CFR Part 11, ICH guidelines and FDA regulations.
  • Knowledge of standard medical coding dictionaries, such as MedDRA and WHODrug.
  • Strong technical skills and experience working in clinical data management systems (EDC, IxRS); experience in Medidata RAVE preferred.
  • Experience working on Oncology clinical studies preferred.
  • Proven ability to work both independently and in a team setting.

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.

1740342

Job Description Summary

The Director of Project Management will strategically lead the optimal global development of an asset, advancing programs through all stages of clinical development and life-cycle management. This role will work with various stakeholders across Mirati and will help define and outline a strategic vision. This role will apply a strong project management discipline to lead the establishment of detailed operational plans in alignment with corporate strategies and financial metrics across the continuum of research, development and commercial. With experience in cross-functional team management, the Project Manager provides end-to-end oversight of the asset lifecycle activities across all working groups to align with corporate goals and objectives.

Your Responsibilities

  • Leads teams to develop and recommend the asset-level strategy to senior leadership, incorporating clear goals, milestone timing, and budget considerations
  • Accountable for overseeing the creation of the Asset Development Plan and the associated functional development plans
  • Leads teams to identify risks and issues, and to develop and propose mitigation plans in a proactive and timely manner
  • Manages the day-to-day execution of integrated cross-functional team activities to meet or exceed annual program and corporate goals
  • Creates and embeds core processes and metrics and holds others accountable to timelines, data, and advancing the asset
  • Promptly escalates barriers to project delivery, particularly related to resource shortfall, performance issues, process inefficiencies, or other environmental factors
  • Drives preparation of governance board deliverables and ensures implementation of decisions
  • Institutes and monitors corrective measures to ensure team health remains solid
  • Ensures alignment between project plans, functional stakeholders, and alliance partners as required
  • If applicable, liaises with the Director, Alliance Management to ensure delivery of alliance goals
  • If applicable, conducts and manages routine alliance partnership meetings as they pertain to project/program delivery
  • Utilize databasing tools to track detailed project plans in Mirati’s authoritative system for project planning and reporting
  • Identifies and aligns resources (people and financial), team objectives, and strategies behind the vision to ensure successful project completion
  • Works to resolve conflicts among teams and create a positive work environment and team culture
  • Applies project management best practices in the development, initiation, planning, execution, control, and closing of projects
  • Position may include supervisory responsibility

What is Required

  • BS or BA in a scientific discipline required; an advanced degree or PMP certification preferred
  • 12+ years of experience in the biopharmaceutical industry with focus on Oncology
  • 5+ years of experience leading multi-disciplinary development teams in the execution of operational plans; ideally across multiple functional areas and various development phases
  • NDA / MAA submission experience preferred
  • Proven project management and leadership experience/training
  • Must possess exceptional organization and communication skills
  • Strong understanding of drug development strategies, across all critical product development disciplines (Nonclinical, Clinical, CMC, RA/QA, Medical Affairs, Commercial)
  • Strong interpersonal skills and business acumen, excellence in building and managing relationships, ability to understand all perspectives, find common ground and effectively bridge significant differences
  • Detail-oriented while also retaining the ability to see the big picture
  • Demonstrated problem-solving skills with strong business skills/acumen
  • Proven ability to manage multiple projects, set priorities, and meet deadlines
  • Experience working on cross-functional teams to accomplish shared goals
  • Requires flexible work schedule to accommodate program priorities as needed
  • Some travel may be required (10-15%)

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.

1573270

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?

In this position you will be working with top tier talent to lead technical operations activities for a key Mirati asset. This role has room for growth as your skills advance and the products move along the development continuum.

Your Responsibilities:

The Associate Director, CMC Project Management will manage and support Technical Operations projects covering multiple functional areas, including, but not limited to, Clinical and Commercial Manufacturing, Process Development, Analytical Development and Control, Technology Transfer, Validation, CMC Support of Regulatory Filings, and CMC Alliance Management.

Day to Day Duties:

Support the implementation of assigned Technical Operations projects from initiation to implementation

  • Prepare and maintain overall project timeline and provide appropriate benchmarking and risk management information
  • Ensure functional leads have clearly defined project scopes, deliverables and timelines
  • Work with functional leads to ensure that project priorities are clearly documented
  • Follow up on issues, actions and risks to program
  • Apply objective and rational, critical thinking and seek to identify contingency and mitigation plans and enlists key people to resolve obstacles to expedite drug development process through all phases
  • Collect, consolidate and analyze project plans and information across projects
  • Prepare development scenario plans to support decision-making and budgeting process
  • Develop, in conjunction with project team, yearly strategic program and development plans and annual budgets
  • Support overall team function and team leaders in their strategic function
  • Coordinate sub-team activities as required and act as the central core of project team information; ensure activity owners are completing assigned project tasks
  • Maintain primary responsibility for project team meetings, including scheduling, preparation of agendas and minutes, and action items
  • Serve as primary CMC project management contact for business alliances and ensure clear and effective communication across the alliance
  • Develop effective and accurate project metrics reporting criteria and standards
  • Prepare monthly, quarterly and other ad hoc presentations and status reports for Senior Management
  • Conduct reviews (e.g., risk or issue reviews, team evaluations, project post-mortems)
  • Act independently to determine methods and procedures on special assignments

What is Required:

Leadership Attributes

  • Must possess exceptional organizational and communication skills
  • Strong interpersonal skills and business acumen, excellence in building and managing relationships, ability to understand all perspectives, find common ground and effectively bridge significant differences
  • Detail-oriented while also retaining the ability to see the big picture
  • Demonstrated problem solving skills with strong business skills/acumen
  • Proven ability to manage multiple projects, set priorities and meet deadlines
  • Experience working on cross-functional teams to accomplish shared goals

Education/Skills:

  • BS or BA in Science or Engineering required; an advanced degree or PMP certification preferred
  • 8+ years of experience in pharmaceutical/biotechnology development area, including first-hand understanding of drug development process
  • Solid understanding of clinical manufacturing, process development, analytical development and control, technology transfer, validation, and CMC support of regulatory filings.
  • Experience in project management in global pharmaceutical drug development
  • Proven skills to independently manage and influence multiple project activities and plans simultaneously; direct management of at least one complex program
  • Significant experience operating in a virtual business model
  • Knowledge of ISO, Quality Systems and work in an FDA regulated industry
  • Experience with planning, procurement, forecasting, logistics and customer service
  • Proficiency / experience with the use of Microsoft Project, Excel, Word and Power Point is required
  • Strong analytical, interpersonal, leadership and communications skills
  • Proven ability to lead cross-functional project teams globally, to manage by influence and to work with diverse teams
  • Expertise in decision analysis and conflict resolution
  • This position may require approximately 10-20 percent travel, domestic and international

Mirati’s policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

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