Director, Clinical Development Scientist

Job Description Summary

Collaborates with Clinical Development colleagues to efficiently design and effectively execute high quality clinical studies in close partnership with Clinical Operations. Your accountabilities include timely delivery of the protocol, clinical data review, and support of the appropriate interpretation and communication of data. As well as maintaining compliance with internal and external standards, mitigating risk and managing emerging clinical issues within the trial and being a contact for external investigators and internal study teams for questions relating to clinical/medical aspects of the protocol.

Your Responsibilities

  • In collaboration with the Medical Director, leads development and clinical/scientific execution of study protocols and amendments
  • Ensures appropriate data review, interpretation of study results, and reporting in collaboration with other functional groups.
  • Reviews and tracks emerging efficacy and safety data including adverse events and laboratory results, and keeps Medical Director informed of changes in the efficacy/safety as they occur and take action as appropriate
  • Conducts medical monitoring and addresses medical inquiries (only if Medically Qualified individual)
  • Works with the Medical Director to conduct routine safety reviews
  • Contributes to study documents, including ICF templates, eCRFs and SAE report forms
  • Supports development of clinical sections of regulatory documents, including investigator brochures, annual safety update reports, and clinical study reports
  • Supports and interfaces with Clinical Operations and study level project team throughout trial conduct
  • Collaborates with Medical Director to communicate study data results to colleagues, both internally and externally.
  • Assists with preparation of various presentations, including meeting abstracts, posters, oral presentations and advisory boards
  • Interprets, reports and prepares written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions
  • Assists with preparing responses to questions from Health Authorities and Ethics Committees
  • Prepares and may present scientific/clinical information at SIVs and internal and external meetings
  • Contributes to the clinical development strategy
  • Works closely with Quality to ensure flawless conduct of clinical aspects of trials
  • Ensures consistency across studies
  • Reviews medical literature and related new technologies
  • May support integrated document development for marketing authorization filing
  • May support preparation for the FDA Oncology Drug Advisory Committee and EU Oral Explanation

What is Required

  • Advanced medical degree preferred (not required)
  • Minimum of 10 years oncology clinical development experience
  • Significant experience in developing and writing study protocols, study procedures manuals, informed consent forms and clinical study reports
  • In depth knowledge of regulatory guidelines and ICH/GCP
  • Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary
  • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective 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

Medical Director

Job Description Summary

The Medical Director will act as a subject matter expert in Clinical Development providing medical and clinical leadership and oversight for Mirati Phase 1‑3 oncology clinical trial(s) as described in the responsibilities below. You will be responsible for being a single point of accountability for the clinical trial(s) you lead, effectively collaborating with external (eg, Investigators, regulatory agencies) and internal key stakeholders towards successful study implementation.

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.), preferably with Board Certification in Medical Oncology / Hematology Oncology or Internal Medicine
  • Ideally 5-8 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.

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

Associate Director, Biostatistics

Job Description Summary

The Associate Director, Biostatistics will provide statistical expertise to support Medical Affairs, Health Economics and Outcomes Research, and Real World Evidence generation. Responsibilities includes recommendation of study design, endpoint selection, perform statistical analysis, provide input to proposed protocol concepts, contribute to publication development and reviews, and participate in working groups across clinical development through commercialization. In this role, the associate director ensures all aspects of the projects meet the statistical rigors and standards, regulatory requirements, and quality deliverables are met and are aligned with clinical development and commercialization goals. The director will oversee external vendors and interprets/presents the analysis results in easily understandable terms to non-statistical audience.

Your Responsibilities

  • Provide statistical expertise to Medical Affairs and HEOR to ensure appropriate statistical principles are applied and the interpretation of the results are statistically valid
  • Partner with team members from Biometrics, Clinical Development, HEOR/RWE, Medical affairs to achieve team project goals
  • Provide statistical input to study concepts and proposals from investigators (Investigator Sponsor Trials) and ensure strategic alignment with the product lifecycle
  • Participate in the publication planning and perform exploratory analysis in support of the publication plans
  • Partner with external vendors and/or independently perform statistical modeling and analysis of patient reported outcomes data using accepted statistical methodologies and/or other advanced statistical approaches in support of value demonstration to patients and other stakeholders
  • Review and provide statistical input to protocols, reports, value/reimbursement dossiers, and other ad hoc data requests
  • Partner with cross functional team to develop and implement an effective plan to leverage RWE, where applicable
  • In collaboration with team members, select vendors to assist on projects for Medical Affairs and HEOR/RWE as necessary
  • Manage vendors by providing proper oversight to ensure quality deliverables and on-time delivery
  • Provide computational and statistical advice on complex analytic issues supporting RWE projects and be able to work in an autonomous manner; participate in disease specific RWE meetings as needed

What is Required

  • PhD or MS in statistics, biostatistics, or closely related discipline; a minimum of 5 (for PhD) or 8 (for MS) years of experience for Ph.D. and 8 years of working in Medical Affairs, HEOR, and/or RWE
  • Oncology experience preferred
  • Strong programming skills in SAS and/or R and other statistical analysis software
  • Experienced in statistical modeling and simulations
  • Experienced with advanced inferential statistics (including and not limited to longitudinal data analysis, missing data methods, cost-effectiveness analysis, meta-analysis, Bayesian methods), real-world data analysis methods such as propensity scores, machine learning, and related techniques
  • Prior exposure working with value/reimbursement dossiers and interactions with regulatory agencies or HTAs, 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