Kura Oncology, Inc
Associate Director, Regulatory Affairs Operations New Boston, MA
Kura Oncology, Inc, Mississippi State, Mississippi, us, 39762
Associate Director, Regulatory Affairs Operations Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.
Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Essential Job Functions
Direct all regulatory submissions management activities, including submission content and timeline planning and coordination of dossier compilation and QC review to ensure submission quality and compliance for health authority acceptance. Act as submission manager for applications and represent Regulatory Operations on relevant project teams, as needed. Ensure document management tasks are completed in a compliant manner including creation, tracking, storage, and archival of regulatory submissions, correspondence, and other documentation. Manage regulatory records, logs, and databases. Key contact for all enterprise systems related timelines and projects for regulatory information and document management. Serve as business system/process owner, as needed. Oversee the implementation and operation of software and business processes for electronic document and regulatory information management systems (e.g., Veeva RIM), eCTD templates, eCTD publishing tools, and other products as needed (e.g., Veeva PromoMats). Lead the development and implementation of internal procedures, work instructions, and training programs for document and dossier management, archiving, and other processes, as needed. Review and contribute to the creation of standards, templates, and procedures related to regulatory documents, and recommend associated process improvements. Take ownership of building and improving standards, templates, and workflows to create scalable, repeatable processes. Responsible for vendor management, building relationships with business partners and managing budgets and contracts. Provide subject matter expert level strategic insight on regulatory technologies and processes related to registration documents, submission records and associated product data records. Monitor and assess business trends, pending regulations and/or guidance documents for potential regulatory operations impact. Other duties as assigned. Job Requirements
BA/BS degree in a science or related field, or equivalent combination of education, experience, and training. 8+ years regulatory operations experience in a biotechnology or pharmaceutical environment with demonstrated ability to present and articulate requirements. Advanced knowledge of regulatory submission requirements, guidelines, and publishing standards, including computer word processing, electronic document management systems, and publishing software. Extensive eCTD filing experience with IND/CTA and NDA stages, including labeling and post-approval promotional materials. Experience managing an outsourced regulatory publishing model is a plus. Experience managing medium to large scale systems (e.g., RIM, EDMS). Experience with Veeva RIM and PromoMats, a plus. Demonstrated ability to facilitate, lead and manage the establishment of procedures. Must be highly detail oriented with the ability to multi-task and shift priorities quickly under tight deadlines with minimal oversight. Drives work independently with ownership and accountability; delivers consistent, high-quality results with minimal oversight. Thrives in a fast-paced, dynamic environment and adapts quickly to shifting priorities. Builds scalable processes and finds better ways of working, always looking to improve efficiency and quality. Strong communicator and collaborator; works effectively across teams and with vendors to keep projects moving. Detail-oriented and organized, with the ability to manage multiple priorities and meet deadlines. Kura’s Values that are used for candidate selection and performance assessments:
We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package
Competitive comp package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a variety of plans available with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice Interested in building your career at Kura Oncology? Get future opportunities sent straight to your email. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Kura Oncology’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Essential Job Functions
Direct all regulatory submissions management activities, including submission content and timeline planning and coordination of dossier compilation and QC review to ensure submission quality and compliance for health authority acceptance. Act as submission manager for applications and represent Regulatory Operations on relevant project teams, as needed. Ensure document management tasks are completed in a compliant manner including creation, tracking, storage, and archival of regulatory submissions, correspondence, and other documentation. Manage regulatory records, logs, and databases. Key contact for all enterprise systems related timelines and projects for regulatory information and document management. Serve as business system/process owner, as needed. Oversee the implementation and operation of software and business processes for electronic document and regulatory information management systems (e.g., Veeva RIM), eCTD templates, eCTD publishing tools, and other products as needed (e.g., Veeva PromoMats). Lead the development and implementation of internal procedures, work instructions, and training programs for document and dossier management, archiving, and other processes, as needed. Review and contribute to the creation of standards, templates, and procedures related to regulatory documents, and recommend associated process improvements. Take ownership of building and improving standards, templates, and workflows to create scalable, repeatable processes. Responsible for vendor management, building relationships with business partners and managing budgets and contracts. Provide subject matter expert level strategic insight on regulatory technologies and processes related to registration documents, submission records and associated product data records. Monitor and assess business trends, pending regulations and/or guidance documents for potential regulatory operations impact. Other duties as assigned. Job Requirements
BA/BS degree in a science or related field, or equivalent combination of education, experience, and training. 8+ years regulatory operations experience in a biotechnology or pharmaceutical environment with demonstrated ability to present and articulate requirements. Advanced knowledge of regulatory submission requirements, guidelines, and publishing standards, including computer word processing, electronic document management systems, and publishing software. Extensive eCTD filing experience with IND/CTA and NDA stages, including labeling and post-approval promotional materials. Experience managing an outsourced regulatory publishing model is a plus. Experience managing medium to large scale systems (e.g., RIM, EDMS). Experience with Veeva RIM and PromoMats, a plus. Demonstrated ability to facilitate, lead and manage the establishment of procedures. Must be highly detail oriented with the ability to multi-task and shift priorities quickly under tight deadlines with minimal oversight. Drives work independently with ownership and accountability; delivers consistent, high-quality results with minimal oversight. Thrives in a fast-paced, dynamic environment and adapts quickly to shifting priorities. Builds scalable processes and finds better ways of working, always looking to improve efficiency and quality. Strong communicator and collaborator; works effectively across teams and with vendors to keep projects moving. Detail-oriented and organized, with the ability to manage multiple priorities and meet deadlines. Kura’s Values that are used for candidate selection and performance assessments:
We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package
Competitive comp package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a variety of plans available with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice Interested in building your career at Kura Oncology? Get future opportunities sent straight to your email. Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Kura Oncology’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A \"disabled veteran\" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A \"recently separated veteran\" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An \"active duty wartime or campaign badge veteran\" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An \"Armed forces service medal veteran\" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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