Kura Oncology
Manager/Senior Manager, Clinical Data Sciences
Kura Oncology, San Diego, California, United States, 92189
Overview
Manager/Senior Manager, Clinical Data Sciences role at Kura Oncology. Join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines. The organization is focused on changing the paradigm and improving the science of cancer treatment, cultivating a diverse and talented professional culture driven to develop precision medicine therapeutics. A patient-focused mindset and relentless execution are central to success at Kura. To succeed, you should demonstrate excellence in drug discovery and development with a roll-up-your-sleeves attitude, and maintain a values-driven work style where integrity and grit guide decisions and actions. Responsibilities
Provide clear, consistent communication to Kura’s CROs and third-party vendors regarding data management deliverables and monitor performance against expectations. Coordinate internal team review and feedback during EDC builds and migrations; give clear guidance to data management and EDC build teams. Accountable for DM task and milestone timelines. Ensure data quality and integrity for clinical study data collection activities. Work with the clinical team to define and maintain the Kura Comprehensive Data Review Plan. Lead study teams in the review of clinical study data per the Comprehensive Data Review Plan. Prepare and provide internal data listings and reports as required. Review protocols for data collection and management feasibility. Provide leadership to the study team for data management activities across the study lifecycle: planning, start-up, conduct, close-out. Create and deliver DM documentation (eCRFs, CCGs, DMP, Data Transfer Specifications, etc.) and ensure proper filing within the TMF. Review study budgets and provide input on data collection, cleaning, and reporting related to vendor contracts. Partner with internal content experts to manage data collection/maintenance with external vendors and ensure deliverables meet project milestones and program objectives. Track and document data management decisions. Initiate and chair meetings for assigned studies and initiatives; support and contribute to clinical trial timelines as they relate to data management. Manage accruals tracking and vendor payments for data management activities. Contribute to development of departmental procedures documentation. Perform other duties as assigned. Qualifications
A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field. 5+ years’ experience in data management or relevant work in the pharmaceutical/biopharma industry. Experience in oncology strongly preferred. Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out). Significant experience overseeing database migrations. Experience with an NDA submission desirable. Ability to provide independent DM subject matter expertise to study teams and vendors for DM obligations. Experience with one or more EDC platforms (Rave, InForm, etc.). Experience with data integration/visualization platforms (e.g., Saama, elluminate) desirable. Solid understanding of the clinical drug development process, regulatory requirements, and ICH/GCP guidelines. Excellent planning, organization and time management skills with the ability to prioritize multiple projects. Excellent interpersonal, verbal, and written communication skills. Flexibility to travel up to approximately 5% of the time. Compensation
The base range for a Manager is $150,000 - $180,000 and for a Senior Manager it is $178,000 - $213,000 per year. Pay may vary based on skills, experience, location, and education. The compensation package includes benefits, equity, and participation in an annual target bonus. About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for cancer. The pipeline features small molecule candidates targeting cancer signaling pathways. Ziftomenib, a once-daily oral menin inhibitor, is the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed/refractory NPM1-mutant AML. In 2024, Kura entered a global strategic collaboration with Kyowa Kirin to develop ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 trial in R/R NPM1-mutant AML has been completed, and in 2025 the FDA accepted a New Drug Application for ziftomenib in this indication. Kura is also advancing other programs in various cancer indications. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Equal Opportunity and Privacy
We provide an Equal Employment Opportunity policy and comply with applicable laws. California residents can refer to the CA Privacy Notice. This job description does not constitute a contract of employment or a promise of employment and may be changed at any time at the company’s discretion.
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Manager/Senior Manager, Clinical Data Sciences role at Kura Oncology. Join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines. The organization is focused on changing the paradigm and improving the science of cancer treatment, cultivating a diverse and talented professional culture driven to develop precision medicine therapeutics. A patient-focused mindset and relentless execution are central to success at Kura. To succeed, you should demonstrate excellence in drug discovery and development with a roll-up-your-sleeves attitude, and maintain a values-driven work style where integrity and grit guide decisions and actions. Responsibilities
Provide clear, consistent communication to Kura’s CROs and third-party vendors regarding data management deliverables and monitor performance against expectations. Coordinate internal team review and feedback during EDC builds and migrations; give clear guidance to data management and EDC build teams. Accountable for DM task and milestone timelines. Ensure data quality and integrity for clinical study data collection activities. Work with the clinical team to define and maintain the Kura Comprehensive Data Review Plan. Lead study teams in the review of clinical study data per the Comprehensive Data Review Plan. Prepare and provide internal data listings and reports as required. Review protocols for data collection and management feasibility. Provide leadership to the study team for data management activities across the study lifecycle: planning, start-up, conduct, close-out. Create and deliver DM documentation (eCRFs, CCGs, DMP, Data Transfer Specifications, etc.) and ensure proper filing within the TMF. Review study budgets and provide input on data collection, cleaning, and reporting related to vendor contracts. Partner with internal content experts to manage data collection/maintenance with external vendors and ensure deliverables meet project milestones and program objectives. Track and document data management decisions. Initiate and chair meetings for assigned studies and initiatives; support and contribute to clinical trial timelines as they relate to data management. Manage accruals tracking and vendor payments for data management activities. Contribute to development of departmental procedures documentation. Perform other duties as assigned. Qualifications
A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field. 5+ years’ experience in data management or relevant work in the pharmaceutical/biopharma industry. Experience in oncology strongly preferred. Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out). Significant experience overseeing database migrations. Experience with an NDA submission desirable. Ability to provide independent DM subject matter expertise to study teams and vendors for DM obligations. Experience with one or more EDC platforms (Rave, InForm, etc.). Experience with data integration/visualization platforms (e.g., Saama, elluminate) desirable. Solid understanding of the clinical drug development process, regulatory requirements, and ICH/GCP guidelines. Excellent planning, organization and time management skills with the ability to prioritize multiple projects. Excellent interpersonal, verbal, and written communication skills. Flexibility to travel up to approximately 5% of the time. Compensation
The base range for a Manager is $150,000 - $180,000 and for a Senior Manager it is $178,000 - $213,000 per year. Pay may vary based on skills, experience, location, and education. The compensation package includes benefits, equity, and participation in an annual target bonus. About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for cancer. The pipeline features small molecule candidates targeting cancer signaling pathways. Ziftomenib, a once-daily oral menin inhibitor, is the first investigational therapy to receive Breakthrough Therapy Designation from the FDA for relapsed/refractory NPM1-mutant AML. In 2024, Kura entered a global strategic collaboration with Kyowa Kirin to develop ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 trial in R/R NPM1-mutant AML has been completed, and in 2025 the FDA accepted a New Drug Application for ziftomenib in this indication. Kura is also advancing other programs in various cancer indications. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Equal Opportunity and Privacy
We provide an Equal Employment Opportunity policy and comply with applicable laws. California residents can refer to the CA Privacy Notice. This job description does not constitute a contract of employment or a promise of employment and may be changed at any time at the company’s discretion.
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