Kura Oncology
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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. 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.
1 Jobs
Manager, Biosample Operations
Kura OncologyKura 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. 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.
Role Description 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. The Manager, Biosample Operations plans, implements, manages and drives biological sample logistics within Kura Oncology Phase I-IV Clinical Trials, working within our Clinical Operations function, under the leadership of the Head of Clinical Operations (or designee) and in collaboration with Clinical Trial Leaders (CTLs) and cross-functional development team. - Advises on and delivers the biosample strategy within clinical program(s) in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP. - Ensures standardization and harmonization of biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation, maximizing biosample sample accrual and quality. - Reviews clinical study protocols, informed consents, laboratory documents, case report forms, and service provider laboratory scope of work documents for sample handling details. - Responsible for ensuring ethical use of biosamples collected in Kura Oncology clinical trials. - Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of patient samples. - Ensures project level consistency occurs for biosampling across studies and is the primary point of contact for project, clinical, and study teams. - Tracks and reports on biosample management status/progress, addresses issues, and resolutions. - Collaborates with internal and external team members. - Completes other duties as assigned by the manager. Qualifications - Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education. - A minimum of 4-6 years of clinical trial management experience preferred. - 2+ years of strong hands-on experience in clinical biosample project management preferred. - Must understand the drug development process in order to effectively manage internal and external cross-functional teams. - Proven ability to build strong relationships with external partners, CROs, and biosample vendors. - In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. - Knowledge of regulations and requirements for clinical trial authorization and tissue storage and transfer in major countries. - Project management skills with ability to identify risks and issues, and propose appropriate measures as required. - Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members. - Analytical thinker with problem-solving skills and the ability to adapt to changing priorities and deadlines. - Excellent verbal and written communication skills. - Planning, organization and time management skills including the ability to support and prioritize multiple projects. - Accountable for executing decisions made within the function. - Collaborates with cross-functional partners as needed to support team objectives and ensure alignment with broader program activities. - Flexibility to travel domestically and internationally as required (~10%). - Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions, EU and Asia filing experience a plus. - Proficiency with Microsoft Office. Benefits - Career advancement/development opportunities. - Competitive compensation 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!
