CD

Cidara Therapeutics

- NASDAQ:CDTX
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# Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated Ticker Sector Ticker Industry
1 nasdaq:cdtx www.cidara.com www.cidara.com Apr 8th, 2019 12:00AM Manager, Regulatory Affairs Open Regulatory Affairs San Diego, CA, United States San Diego CA USA Nov 13th, 2018 12:00AM Position SummaryThe Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials.  The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines.  The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports.  The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.ResponsibilitiesPrepare and maintain global regulatory submissionsCritically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reportsIndependently execute regulatory strategies regarding submissions and/or compliance issuesCoordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations teamRepresent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAsMinimum Qualifications      Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered6-8 years of relevant experience in regulatory affairs with drug or biologic productsExperience with global regulatory submissionsStrong scientific background and experience in critical review and interpretation of scientific/clinical dataAbility to manage conflicting priorities and meeting tight timelinesExperience in interacting with FDA or EU competent authoritiesDemonstrated ability to manage a complex workload and prioritize tasks based on program goals.Strong verbal and written communications skills, as well as problem-solving skillsAbility to work quickly and independently and as a strong team player Preferred Qualifications      Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferredRAC certification will be a plusExperience in infectious disease area is desirable but not requiredThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company Apr 8th, 2019 01:33AM Apr 8th, 2019 01:33AM Health Care Pharmaceuticals & Biotechnology
2 nasdaq:cdtx www.cidara.com www.cidara.com Apr 8th, 2019 12:00AM Manager/Sr. Manager, QA (GCP) Open Quality Assurance San Diego, CA, United States San Diego CA USA Aug 23rd, 2018 12:00AM Position SummaryThis position will support all Quality Assurance GCP activities to ensure quality and compliance of Cidara sponsored clinical trials with respect to applicable GCP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, Cidara Standard Operating Procedures (SOPs), and current industry standards and practices.  Activities will generally fall under the following areas: GCP QA audit program, Cidara quality systems, and internal/clinical study team support.  This position reports to Director, GCP QA. ResponsibilitiesSchedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.Provide GCP QA oversight and support to internal staff.Represent GCP QA on project teams.Review and approve Clinical SOPs.Develop and implement Clinical QA SOPs.Ensure the timely and effective follow up of all identified or assigned quality issues.Assist Clinical Operations in preparing investigational sites for regulatory inspections.Support the Director in the QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.Perform CSR audits.Perform eTMF audits.Manage and/or deliver yearly GCP training for internal staff. Minimum Qualifications      Bachelor’s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.Minimum of 7 years in the Pharmaceutical industry with 3 years in GCP QA.Solid understanding of GCP and ICH clinical requirements.Experience with both domestic and international clinical studies.Able to work independently with minimal direction.Able to travel domestically and internationally approximately 25% of the time. The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an E-Verify Company Apr 8th, 2019 01:33AM Apr 8th, 2019 01:33AM Health Care Pharmaceuticals & Biotechnology
3 nasdaq:cdtx www.cidara.com www.cidara.com Apr 14th, 2019 12:00AM Manager, Regulatory Affairs Open Regulatory Affairs San Diego, CA, United States San Diego CA USA Nov 13th, 2018 12:00AM Position SummaryThe Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials.  The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines.  The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports.  The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.ResponsibilitiesPrepare and maintain global regulatory submissionsCritically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reportsIndependently execute regulatory strategies regarding submissions and/or compliance issuesCoordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations teamRepresent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAsMinimum Qualifications      Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered6-8 years of relevant experience in regulatory affairs with drug or biologic productsExperience with global regulatory submissionsStrong scientific background and experience in critical review and interpretation of scientific/clinical dataAbility to manage conflicting priorities and meeting tight timelinesExperience in interacting with FDA or EU competent authoritiesDemonstrated ability to manage a complex workload and prioritize tasks based on program goals.Strong verbal and written communications skills, as well as problem-solving skillsAbility to work quickly and independently and as a strong team player Preferred Qualifications      Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferredRAC certification will be a plusExperience in infectious disease area is desirable but not requiredThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company Apr 14th, 2019 01:32AM Apr 14th, 2019 01:32AM Health Care Pharmaceuticals & Biotechnology
4 nasdaq:cdtx www.cidara.com www.cidara.com Apr 14th, 2019 12:00AM Manager/Sr. Manager, QA (GCP) Open Quality Assurance San Diego, CA, United States San Diego CA USA Aug 23rd, 2018 12:00AM Position SummaryThis position will support all Quality Assurance GCP activities to ensure quality and compliance of Cidara sponsored clinical trials with respect to applicable GCP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, Cidara Standard Operating Procedures (SOPs), and current industry standards and practices.  Activities will generally fall under the following areas: GCP QA audit program, Cidara quality systems, and internal/clinical study team support.  This position reports to Director, GCP QA. ResponsibilitiesSchedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.Provide GCP QA oversight and support to internal staff.Represent GCP QA on project teams.Review and approve Clinical SOPs.Develop and implement Clinical QA SOPs.Ensure the timely and effective follow up of all identified or assigned quality issues.Assist Clinical Operations in preparing investigational sites for regulatory inspections.Support the Director in the QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.Perform CSR audits.Perform eTMF audits.Manage and/or deliver yearly GCP training for internal staff. Minimum Qualifications      Bachelor’s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.Minimum of 7 years in the Pharmaceutical industry with 3 years in GCP QA.Solid understanding of GCP and ICH clinical requirements.Experience with both domestic and international clinical studies.Able to work independently with minimal direction.Able to travel domestically and internationally approximately 25% of the time. The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an E-Verify Company Apr 14th, 2019 01:32AM Apr 14th, 2019 01:32AM Health Care Pharmaceuticals & Biotechnology
5 nasdaq:cdtx www.cidara.com www.cidara.com Apr 15th, 2019 12:00AM Manager, Regulatory Affairs Open Regulatory Affairs San Diego, CA, United States San Diego CA USA Nov 13th, 2018 12:00AM Position SummaryThe Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials.  The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines.  The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports.  The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.ResponsibilitiesPrepare and maintain global regulatory submissionsCritically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reportsIndependently execute regulatory strategies regarding submissions and/or compliance issuesCoordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations teamRepresent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAsMinimum Qualifications      Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered6-8 years of relevant experience in regulatory affairs with drug or biologic productsExperience with global regulatory submissionsStrong scientific background and experience in critical review and interpretation of scientific/clinical dataAbility to manage conflicting priorities and meeting tight timelinesExperience in interacting with FDA or EU competent authoritiesDemonstrated ability to manage a complex workload and prioritize tasks based on program goals.Strong verbal and written communications skills, as well as problem-solving skillsAbility to work quickly and independently and as a strong team player Preferred Qualifications      Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferredRAC certification will be a plusExperience in infectious disease area is desirable but not requiredThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company Apr 15th, 2019 01:29AM Apr 15th, 2019 01:29AM Health Care Pharmaceuticals & Biotechnology
6 nasdaq:cdtx www.cidara.com www.cidara.com Apr 15th, 2019 12:00AM Manager/Sr. Manager, QA (GCP) Open Quality Assurance San Diego, CA, United States San Diego CA USA Aug 23rd, 2018 12:00AM Position SummaryThis position will support all Quality Assurance GCP activities to ensure quality and compliance of Cidara sponsored clinical trials with respect to applicable GCP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, Cidara Standard Operating Procedures (SOPs), and current industry standards and practices.  Activities will generally fall under the following areas: GCP QA audit program, Cidara quality systems, and internal/clinical study team support.  This position reports to Director, GCP QA. ResponsibilitiesSchedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.Provide GCP QA oversight and support to internal staff.Represent GCP QA on project teams.Review and approve Clinical SOPs.Develop and implement Clinical QA SOPs.Ensure the timely and effective follow up of all identified or assigned quality issues.Assist Clinical Operations in preparing investigational sites for regulatory inspections.Support the Director in the QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.Perform CSR audits.Perform eTMF audits.Manage and/or deliver yearly GCP training for internal staff. Minimum Qualifications      Bachelor’s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.Minimum of 7 years in the Pharmaceutical industry with 3 years in GCP QA.Solid understanding of GCP and ICH clinical requirements.Experience with both domestic and international clinical studies.Able to work independently with minimal direction.Able to travel domestically and internationally approximately 25% of the time. The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an E-Verify Company Apr 15th, 2019 01:29AM Apr 15th, 2019 01:29AM Health Care Pharmaceuticals & Biotechnology
7 nasdaq:cdtx www.cidara.com www.cidara.com Apr 23rd, 2019 12:00AM Manager, Regulatory Affairs Open Regulatory Affairs San Diego, CA, United States San Diego CA USA Nov 13th, 2018 12:00AM Position SummaryThe Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials.  The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines.  The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports.  The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.ResponsibilitiesPrepare and maintain global regulatory submissionsCritically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reportsIndependently execute regulatory strategies regarding submissions and/or compliance issuesCoordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations teamRepresent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAsMinimum Qualifications      Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered6-8 years of relevant experience in regulatory affairs with drug or biologic productsExperience with global regulatory submissionsStrong scientific background and experience in critical review and interpretation of scientific/clinical dataAbility to manage conflicting priorities and meeting tight timelinesExperience in interacting with FDA or EU competent authoritiesDemonstrated ability to manage a complex workload and prioritize tasks based on program goals.Strong verbal and written communications skills, as well as problem-solving skillsAbility to work quickly and independently and as a strong team player Preferred Qualifications      Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferredRAC certification will be a plusExperience in infectious disease area is desirable but not requiredThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company Apr 23rd, 2019 12:34AM Apr 23rd, 2019 12:34AM Health Care Pharmaceuticals & Biotechnology
8 nasdaq:cdtx www.cidara.com www.cidara.com Apr 23rd, 2019 12:00AM Manager/Sr. Manager, QA (GCP) Open Quality Assurance San Diego, CA, United States San Diego CA USA Aug 23rd, 2018 12:00AM Position SummaryThis position will support all Quality Assurance GCP activities to ensure quality and compliance of Cidara sponsored clinical trials with respect to applicable GCP regulations (e.g., FDA, EU, country-specific), ICH GCP guidelines, Cidara Standard Operating Procedures (SOPs), and current industry standards and practices.  Activities will generally fall under the following areas: GCP QA audit program, Cidara quality systems, and internal/clinical study team support.  This position reports to Director, GCP QA. ResponsibilitiesSchedule, oversee and perform routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, processes, systems and study documents to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.Provide GCP QA oversight and support to internal staff.Represent GCP QA on project teams.Review and approve Clinical SOPs.Develop and implement Clinical QA SOPs.Ensure the timely and effective follow up of all identified or assigned quality issues.Assist Clinical Operations in preparing investigational sites for regulatory inspections.Support the Director in the QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.Perform CSR audits.Perform eTMF audits.Manage and/or deliver yearly GCP training for internal staff. Minimum Qualifications      Bachelor’s Degree in a scientific discipline, a combination of relevant education and applicable job experience may be considered.Minimum of 7 years in the Pharmaceutical industry with 3 years in GCP QA.Solid understanding of GCP and ICH clinical requirements.Experience with both domestic and international clinical studies.Able to work independently with minimal direction.Able to travel domestically and internationally approximately 25% of the time. The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an E-Verify Company Apr 23rd, 2019 12:34AM Apr 23rd, 2019 12:34AM Health Care Pharmaceuticals & Biotechnology
9 nasdaq:cdtx www.cidara.com www.cidara.com Apr 18th, 2019 12:00AM Manager, Regulatory Affairs Open Regulatory Affairs San Diego, CA, United States San Diego CA USA Nov 13th, 2018 12:00AM Position SummaryThe Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials.  The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines.  The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports.  The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.ResponsibilitiesPrepare and maintain global regulatory submissionsCritically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reportsIndependently execute regulatory strategies regarding submissions and/or compliance issuesCoordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations teamRepresent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAsMinimum Qualifications      Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered6-8 years of relevant experience in regulatory affairs with drug or biologic productsExperience with global regulatory submissionsStrong scientific background and experience in critical review and interpretation of scientific/clinical dataAbility to manage conflicting priorities and meeting tight timelinesExperience in interacting with FDA or EU competent authoritiesDemonstrated ability to manage a complex workload and prioritize tasks based on program goals.Strong verbal and written communications skills, as well as problem-solving skillsAbility to work quickly and independently and as a strong team player Preferred Qualifications      Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferredRAC certification will be a plusExperience in infectious disease area is desirable but not requiredThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company Apr 18th, 2019 12:44AM Apr 18th, 2019 12:44AM Health Care Pharmaceuticals & Biotechnology
10 nasdaq:cdtx www.cidara.com www.cidara.com Apr 17th, 2019 12:00AM Manager, Regulatory Affairs Open Regulatory Affairs San Diego, CA, United States San Diego CA USA Nov 13th, 2018 12:00AM Position SummaryThe Manager, Regulatory Affairs will contribute to the Regulatory Affairs department in the initiation and maintenance of global Phase 3 clinical trials.  The RA manager will represent Regulatory Affairs on cross- functional project teams and provide regulatory support and guidance regarding overall regulatory strategy to ensure high quality submissions in compliance with global regulations and guidelines.  The RA manger will be responsible for reviewing the content of regulatory submissions (INDs, CTAs, NDA/MAA), briefing books, clinical protocols and nonclinical reports.  The RA manager will interact with contract vendors to provide documentation requested by them for global submissions. Reports to the Senior Director, Regulatory Affairs.ResponsibilitiesPrepare and maintain global regulatory submissionsCritically review contents of clinical, nonclinical or CMC regulatory documents, protocols and reportsIndependently execute regulatory strategies regarding submissions and/or compliance issuesCoordinate timely planning of routine regulatory submissions with the Regulatory Affairs Operations teamRepresent Regulatory Affairs to cross-functional project teams and CROs as required at the study team level for management of CTAsMinimum Qualifications      Bachelor's in scientific discipline or equivalent, combination of relevant education and applicable job experience may be considered6-8 years of relevant experience in regulatory affairs with drug or biologic productsExperience with global regulatory submissionsStrong scientific background and experience in critical review and interpretation of scientific/clinical dataAbility to manage conflicting priorities and meeting tight timelinesExperience in interacting with FDA or EU competent authoritiesDemonstrated ability to manage a complex workload and prioritize tasks based on program goals.Strong verbal and written communications skills, as well as problem-solving skillsAbility to work quickly and independently and as a strong team player Preferred Qualifications      Advanced degree such as Masters in Regulatory Sciences or other scientific disciplines will be preferredRAC certification will be a plusExperience in infectious disease area is desirable but not requiredThe content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned.   The Company reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.Cidara Therapeutics is an EEO/AA/Disability/Vets Employer and an E-Verify Company Apr 17th, 2019 01:30AM Apr 17th, 2019 01:30AM Health Care Pharmaceuticals & Biotechnology

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