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nasdaq:mrtx
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mirati.applicantpro.com
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mirati.applicantpro.com
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Sep 19th, 2020 12:00AM
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Director, Analytical Development 2020-38
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Open
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Mirati Therapeutics Inc
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FULL_TIME
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|
San Diego
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CA
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USA
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Aug 21st, 2020 12:00AM
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|
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
Who are we: 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 Director, Analytical Development will report to the head of Analytical Development and will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and cGMP). He/she will provide analytical support for API and drug product manufacture in support of preclinical, clinical, registrational, and commercial batches.
Your Responsibilities:
Work with multi-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard characterization, and product characterization.
Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs.
Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing.
Manage analytical activities at CROs/CMOs including method development and qualification/validation, characterization testing. Review of analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
Resolve technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
Author/review technical documents outlining analytical activities including method validation, reference standard and impurity characterization, stability, etc.
Author/review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
Represent analytical function in CMC teams and interdepartmental meetings
What is Required:
Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 10+ years of relevant industrial experience, or BS +15 or more years' experience
Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3)
Extensive analytical method development, troubleshooting, and validation experience
In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc), identification of impurities and degradation products, reference standard qualification.
Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
Experience preparing and updating regulatory filings (IND, NDA, MAA)
Outstanding written and verbal communication skills
Ability to effectively organize and prioritize tasks to achieve established deadlines
Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
Proven problem-solving skills are a must
Ability to travel up to 25% 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.
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Sep 19th, 2020 06:34AM
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Sep 19th, 2020 06:34AM
|
Mirati Therapeutics
|
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:mrtx
|
mirati.applicantpro.com
|
mirati.applicantpro.com
|
Sep 19th, 2020 12:00AM
|
Sr Manager Analytical Development 2020-121
|
Open
|
Mirati Therapeutics Inc
|
FULL_TIME
|
|
San Diego
|
CA
|
USA
|
Sep 2nd, 2020 12:00AM
|
|
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
Who are we: 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 Sr Manager, Analytical Development will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and cGMP). He/she will provide analytical support for API and drug product manufacture in support of preclinical, clinical, registrational, and commercial batches.
Your Responsibilities:
Work with multi-functional project teams to execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard and product characterization.
Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs.
Provide support in identifying y and recommending analytical methodologies to support chemical development, formulation development, QC and stability testing.
Manage when appropriate analytical activities at CROs/CMOs including method development and qualification/validation, characterization testing. Review of analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
Provide technical support in resolving technical issues, reviewing deviation events and failure investigations at contractor sites in coordination with internal and external. quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
Author/review technical documents outlining analytical activities including method validation, management of reference standard program and impurities characterization, stability, etc.
Provide support in authoring or review of analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
Represent analytical function in CMC teams and interdepartmental meetings.
What is Required:
Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 3+ years of relevant industrial experience, or BS +10 or more years' experience
Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3, with an emphasis on late stage development)
Extensive analytical method development, troubleshooting, and validation experience
In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, reference standard qualification.
Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
Experience writing analytical sections of regulatory filings (IND, NDA, IMPD, MAA)
Outstanding written and verbal communication skills
Ability to effectively organize and prioritize tasks to achieve established deadlines
Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
Proven problem-solving skills are a must
Ability to travel up to 25% 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.
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Sep 19th, 2020 06:34AM
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Sep 19th, 2020 06:34AM
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Mirati Therapeutics
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|
Pharmaceuticals & Biotechnology
|
|
nasdaq:mrtx
|
mirati.applicantpro.com
|
mirati.applicantpro.com
|
Sep 19th, 2020 12:00AM
|
In Vivo Pharmacologist 2020-136
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Open
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Mirati Therapeutics Inc
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FULL_TIME
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San Diego
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CA
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USA
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Sep 9th, 2020 12:00AM
|
|
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
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 In Vivo Pharmacologist will report to the in vivo Pharmacology Group Leader and will be primarily responsible for generating in vivo pre-clinical data, testing novel small molecule therapies and immunotherapies in clinically relevant mouse cancer models. The candidate will be responsible for supporting primary pharmacology and translational pharmacology programs. This involves identifying and characterizing novel cancer therapeutics using various cell line and genetically engineered in vivo models to determine optimal doses, routes of administration and dose schedules, to prioritize indications, identify biomarkers, elucidate mechanisms of resistance and identify efficacious combinations. Daily activities will include implanting, ear tagging, measuring and dosing (PO, IP, IV) of various mouse cancer models, tissue collection, drug formulation, in vitro and ex vivo support.
Your Responsibilities:
Support drug discovery projects with relevant in vivo assays and generating primary data packages.
Execute in vivo pharmacology studies in mice (tumor growth inhibition, pharmacodynamic, pharmacokinetic and novel model growth curves).
Use gain-of-function (over expression) and loss-of-function (RNAi, CRISPR/Cas) approaches to study gene function in various in vivo models.
Identify effective combinations with chemotherapies, targeted therapies or immune-modulatory agents.
Identify clinically-tractable biomarkers that may guide patient selection or early-stage drug development.
Maintain vivarium equipment, detailed laboratory files and an electronic notebook.
Present in lab meetings to inform and discuss progress, results and future studies.
What is Required:
Bachelor's degree in a science-related field with direct animal research or two year direct animal research experience with no degree required
Experience in rodent handling and procedures especially in cancer pharmacology
Experience in general laboratory techniques
Highly organized with excellent communication skills
Expertise in Microsoft Office Suite
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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Sep 19th, 2020 06:34AM
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Sep 19th, 2020 06:34AM
|
Mirati Therapeutics
|
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:mrtx
|
mirati.applicantpro.com
|
mirati.applicantpro.com
|
Sep 20th, 2020 12:00AM
|
Associate Director, Regulatory CMC 2020-122
|
Open
|
Mirati Therapeutics Inc
|
FULL_TIME
|
|
San Diego
|
CA
|
USA
|
Jul 13th, 2020 12:00AM
|
|
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
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.
Job Summary:The Associate Director of Regulatory Chemistry, Manufacturing and Controls (CMC) will report directly to the Vice President of Regulatory CMC. The individual will be responsible for working with the CMC teams to guide the CMC global regulatory strategy of Mirati's small molecule programs leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong CMC technical background, experience with preparing CMC regulatory submissions, and responding to Health Authority questions. In addition, excellent verbal and written communications skills are required.
Your Responsibilities:
Participate as the Regulatory CMC Lead on CMC Teams
Lead the preparation of regulatory dossiers (e.g. IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards
Research and provide analysis of current US and international regulations and guidance
Develop and execute global CMC regulatory strategies for analytical, chemical, and product development for small molecule oncology compounds
Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed
Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols and investigator brochures
Communicates critical issues to Management
What is Required:
A minimum of a Bachelor of Science in chemistry or pharmaceutical science with a minimum of 8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required
An MS, Ph.D., or Pharm. D. degree preferred
Knowledge of EU and FDA regulations is required
Experience directly writing submission documents that support clinical trials. Experience writing marketing applications is highly desirable
Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required
Strong attention to detail with high-level verbal and written communication skills is required
Ability to work as part of and lead multiple teams, and to present and defend CMC management-approved regulatory strategy and opinion to project teams is required
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent problem-solving, analytical thinking skills is required
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.
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Sep 20th, 2020 06:45AM
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Sep 20th, 2020 06:45AM
|
Mirati Therapeutics
|
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:mrtx
|
mirati.applicantpro.com
|
mirati.applicantpro.com
|
Sep 20th, 2020 12:00AM
|
Sr Manager Analytical Development 2020-118
|
Open
|
Mirati Therapeutics Inc
|
FULL_TIME
|
|
San Diego
|
CA
|
USA
|
Jul 20th, 2020 12:00AM
|
|
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
Who are we: 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 Sr Manager, Analytical Development will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and cGMP). He/she will provide analytical support for API and drug product manufacture in support of preclinical, clinical, registrational, and commercial batches.
Your Responsibilities:
Work with multi-functional project teams to execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard and product characterization.
Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs.
Provide support in identifying y and recommending analytical methodologies to support chemical development, formulation development, QC and stability testing.
Manage when appropriate analytical activities at CROs/CMOs including method development and qualification/validation, characterization testing. Review of analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
Provide technical support in resolving technical issues, reviewing deviation events and failure investigations at contractor sites in coordination with internal and external. quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
Author/review technical documents outlining analytical activities including method validation, management of reference standard program and impurities characterization, stability, etc.
Provide support in authoring or review of analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
Represent analytical function in CMC teams and interdepartmental meetings.
What is Required:
Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 3+ years of relevant industrial experience, or BS +10 or more years' experience
Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3, with an emphasis on late stage development)
Extensive analytical method development, troubleshooting, and validation experience
In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, reference standard qualification.
Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
Experience writing analytical sections of regulatory filings (IND, NDA, IMPD, MAA)
Outstanding written and verbal communication skills
Ability to effectively organize and prioritize tasks to achieve established deadlines
Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
Proven problem-solving skills are a must
Ability to travel up to 25% 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.
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|
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Sep 20th, 2020 06:45AM
|
Sep 20th, 2020 06:45AM
|
Mirati Therapeutics
|
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:mrtx
|
mirati.applicantpro.com
|
mirati.applicantpro.com
|
Sep 20th, 2020 12:00AM
|
Director, Product Development : 2020-119
|
Open
|
Mirati Therapeutics Inc
|
FULL_TIME
|
|
San Diego
|
CA
|
USA
|
Jul 31st, 2020 12:00AM
|
|
Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
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 Director, Product Development will be responsible for design and development of small molecule solid oral drug products for clinical studies and commercialization. He/she will provide technical expertise towards formulation and 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 and regulatory, to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures (GLP, GMP, ICH). He/she will serve as a subject matter expert in activities related to product development, and author / review relevant sections of the CMC regulatory dossiers.
Your Responsibilities:
Design and develop optimal formulations, and robust, scalable & cost-effective processes for the manufacture of DPs for clinical studies and commercialization. Design and implement efficient DOE's to support formulation and process robustness.
Engage with API process chemistry group to ensure drug substance with optimal physico-chemical properties is advanced towards commercialization. Support material characterization efforts - solid state form, mechanical attributes, particle size assessment, physicochemical stability, etc.
Support preclinical team in the production of optimal formulations and preparation procedures for toxicology and DMPK studies. Provide technical inputs to cross-functions towards clinical dosage form bridging strategies and to manage potential scale-up and post-approval changes.
Support screening and selection of CRO's & CDMO's for drug product, and lead R&D activities for product development and manufacturing at internal and external sites. Work cross functionally with analytical, regulatory, clinical and related teams to achieve program objectives.
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, NDA and IMPD filings, covering all phases of clinical development in both the US and ex-US markets. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external publications and relevant industry benchmarking information to efficiently design product development strategies.
Represent product development function and present work at intra/inter departmental meetings.
What is Required:
Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific field, with 10+ years of related industry experience, or BS with 20+ years of relevant experience.
Highly skilled in formulation design and process development of immediate & modified release oral solid dosage forms. Expert in pharmaceutical manufacturing processes including dry/wet granulation, compression, coating and packaging.
Strong understanding of scientific principals related to pharmaceutics, material science and physical chemistry. Experience in parenteral dosage form development is a plus.
Ability to independently design and implement study plans & DOE's related to drug product & process development, conduct risk assessments and delineate risk mitigation strategies (FMEA).
Experience in technology transfer of drug product to clinical & commercial drug manufacturing sites, including management of activities at CDMO's.
Capability to adapt and improvise based on real time results and findings.
Exceptional written and verbal communication skills. Ability to lead project teams.
Extensive experience in authoring regulatory submissions (IND, NDA, MAA), development reports, batch records, protocols and associated reports (PDR, QbD, Validation).
Strong understanding of ICH, cGMP, worldwide regulatory requirements and current industry best practices.
Ability to travel up to 25% 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.
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|
|
|
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Sep 20th, 2020 06:45AM
|
Sep 20th, 2020 06:45AM
|
Mirati Therapeutics
|
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:mrtx
|
mirati.applicantpro.com
|
mirati.applicantpro.com
|
Sep 21st, 2020 12:00AM
|
Associate Director, Regulatory CMC 2020-122
|
Open
|
Mirati Therapeutics Inc
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FULL_TIME
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|
San Diego
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CA
|
USA
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Jul 13th, 2020 12:00AM
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Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
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.
Job Summary:The Associate Director of Regulatory Chemistry, Manufacturing and Controls (CMC) will report directly to the Vice President of Regulatory CMC. The individual will be responsible for working with the CMC teams to guide the CMC global regulatory strategy of Mirati's small molecule programs leading to successful preparation and approval of Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), New Drug Application (NDA), and Marketing Authorization Application (MAA) submissions. The ideal candidate will have a strong CMC technical background, experience with preparing CMC regulatory submissions, and responding to Health Authority questions. In addition, excellent verbal and written communications skills are required.
Your Responsibilities:
Participate as the Regulatory CMC Lead on CMC Teams
Lead the preparation of regulatory dossiers (e.g. IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards
Research and provide analysis of current US and international regulations and guidance
Develop and execute global CMC regulatory strategies for analytical, chemical, and product development for small molecule oncology compounds
Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements
Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed
Review and guide content of CMC information in nonclinical and clinical documents including clinical protocols and investigator brochures
Communicates critical issues to Management
What is Required:
A minimum of a Bachelor of Science in chemistry or pharmaceutical science with a minimum of 8 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required
An MS, Ph.D., or Pharm. D. degree preferred
Knowledge of EU and FDA regulations is required
Experience directly writing submission documents that support clinical trials. Experience writing marketing applications is highly desirable
Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy is required
Strong attention to detail with high-level verbal and written communication skills is required
Ability to work as part of and lead multiple teams, and to present and defend CMC management-approved regulatory strategy and opinion to project teams is required
Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
Excellent problem-solving, analytical thinking skills is required
Mirati's policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.
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Sep 21st, 2020 05:56AM
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Sep 21st, 2020 05:56AM
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Mirati Therapeutics
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Pharmaceuticals & Biotechnology
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nasdaq:mrtx
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mirati.applicantpro.com
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mirati.applicantpro.com
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Sep 21st, 2020 12:00AM
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Sr Manager Analytical Development 2020-121
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Open
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Mirati Therapeutics Inc
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FULL_TIME
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San Diego
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CA
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USA
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Sep 2nd, 2020 12:00AM
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Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
Who are we: 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 Sr Manager, Analytical Development will be responsible for the development of analytical methodology and characterization activities in support of new drug substance and new drug product development and manufacturing. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and cGMP). He/she will provide analytical support for API and drug product manufacture in support of preclinical, clinical, registrational, and commercial batches.
Your Responsibilities:
Work with multi-functional project teams to execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard and product characterization.
Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs.
Provide support in identifying y and recommending analytical methodologies to support chemical development, formulation development, QC and stability testing.
Manage when appropriate analytical activities at CROs/CMOs including method development and qualification/validation, characterization testing. Review of analytical raw data packages. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
Provide technical support in resolving technical issues, reviewing deviation events and failure investigations at contractor sites in coordination with internal and external. quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
Author/review technical documents outlining analytical activities including method validation, management of reference standard program and impurities characterization, stability, etc.
Provide support in authoring or review of analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
Represent analytical function in CMC teams and interdepartmental meetings.
What is Required:
Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 3+ years of relevant industrial experience, or BS +10 or more years' experience
Experience with analytical development of small molecules and solid oral dosage forms in various stages of development (preclinical to Phase 3, with an emphasis on late stage development)
Extensive analytical method development, troubleshooting, and validation experience
In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc.), identification of impurities and degradation products, reference standard qualification.
Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
Experience writing analytical sections of regulatory filings (IND, NDA, IMPD, MAA)
Outstanding written and verbal communication skills
Ability to effectively organize and prioritize tasks to achieve established deadlines
Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
Proven problem-solving skills are a must
Ability to travel up to 25% 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.
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Sep 21st, 2020 05:56AM
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Sep 21st, 2020 05:56AM
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Mirati Therapeutics
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Pharmaceuticals & Biotechnology
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nasdaq:mrtx
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mirati.applicantpro.com
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mirati.applicantpro.com
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Sep 22nd, 2020 12:00AM
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Director, Product Development : 2020-119
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Open
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Mirati Therapeutics Inc
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FULL_TIME
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San Diego
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CA
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USA
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Jul 31st, 2020 12:00AM
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Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
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 Director, Product Development will be responsible for design and development of small molecule solid oral drug products for clinical studies and commercialization. He/she will provide technical expertise towards formulation and 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 and regulatory, to ensure that drug products are developed and manufactured in compliance with all applicable regulations and corporate procedures (GLP, GMP, ICH). He/she will serve as a subject matter expert in activities related to product development, and author / review relevant sections of the CMC regulatory dossiers.
Your Responsibilities:
Design and develop optimal formulations, and robust, scalable & cost-effective processes for the manufacture of DPs for clinical studies and commercialization. Design and implement efficient DOE's to support formulation and process robustness.
Engage with API process chemistry group to ensure drug substance with optimal physico-chemical properties is advanced towards commercialization. Support material characterization efforts - solid state form, mechanical attributes, particle size assessment, physicochemical stability, etc.
Support preclinical team in the production of optimal formulations and preparation procedures for toxicology and DMPK studies. Provide technical inputs to cross-functions towards clinical dosage form bridging strategies and to manage potential scale-up and post-approval changes.
Support screening and selection of CRO's & CDMO's for drug product, and lead R&D activities for product development and manufacturing at internal and external sites. Work cross functionally with analytical, regulatory, clinical and related teams to achieve program objectives.
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, NDA and IMPD filings, covering all phases of clinical development in both the US and ex-US markets. Assist during quality events (QEs) or failure investigations and implementation of CAPAs at contractor sites.
Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external publications and relevant industry benchmarking information to efficiently design product development strategies.
Represent product development function and present work at intra/inter departmental meetings.
What is Required:
Doctorate (Ph.D.) or Masters (M.S.) degree in Pharmaceutics, Pharmaceutical Science, Chemical Engineering, or related scientific field, with 10+ years of related industry experience, or BS with 20+ years of relevant experience.
Highly skilled in formulation design and process development of immediate & modified release oral solid dosage forms. Expert in pharmaceutical manufacturing processes including dry/wet granulation, compression, coating and packaging.
Strong understanding of scientific principals related to pharmaceutics, material science and physical chemistry. Experience in parenteral dosage form development is a plus.
Ability to independently design and implement study plans & DOE's related to drug product & process development, conduct risk assessments and delineate risk mitigation strategies (FMEA).
Experience in technology transfer of drug product to clinical & commercial drug manufacturing sites, including management of activities at CDMO's.
Capability to adapt and improvise based on real time results and findings.
Exceptional written and verbal communication skills. Ability to lead project teams.
Extensive experience in authoring regulatory submissions (IND, NDA, MAA), development reports, batch records, protocols and associated reports (PDR, QbD, Validation).
Strong understanding of ICH, cGMP, worldwide regulatory requirements and current industry best practices.
Ability to travel up to 25% 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.
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Sep 22nd, 2020 06:12AM
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Sep 22nd, 2020 06:12AM
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Mirati Therapeutics
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Pharmaceuticals & Biotechnology
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nasdaq:mrtx
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mirati.applicantpro.com
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mirati.applicantpro.com
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Sep 22nd, 2020 12:00AM
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AD Clinical Science 2020-138
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Open
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Mirati Therapeutics Inc
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FULL_TIME
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San Diego
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CA
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USA
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Sep 21st, 2020 12:00AM
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Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based clinical-stage biotechnology company dedicated to advancing novel therapeutics that extend the lives of patients by directly addressing the genetic and immunological drivers of cancer. Mirati is developing Sitravatinib, designed to selectively target a spectrum of tyrosine kinases implicated in both tumor growth and the suppression of immune responses to tumors. Sitravatinib has demonstrated durable responses in lung cancer patients whose cancer has progressed despite treatment with checkpoint inhibitors - an area of significant unmet medical need. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a potentially registration-enabling Phase 3 trial of Sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC) that is currently enrolling patients.
Mirati is also developing novel direct inhibitors of KRAS mutations including MRTX849, a potent and selective inhibitor of KRAS G12C. This historically difficult to drug target is present in approximately 14% of NSCLC adenocarcinomas, 4% of colorectal cancer as well as smaller percentages of several other difficult-to-treat cancers. MRTX849 is being evaluated in a Phase 1/2 clinical trial as a treatment for patients with KRAS G12C-positive tumors. Our research on G12C has led to breakthroughs in targeting other KRAS mutations including G12D which drives tumor growth in more patients than G12C and includes pancreatic, colorectal and other types of cancer.
Who are we: 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 Associate Director, Clinical Science provide 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.
7 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.
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Sep 22nd, 2020 06:12AM
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Sep 22nd, 2020 06:12AM
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Mirati Therapeutics
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Pharmaceuticals & Biotechnology
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