Director, Clinical Trial Management

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.

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:

• Leads the planning and execution of a complex, global clinical trial from start-up through close-out, in compliance with regulations/SOPs, within budget and timelines.
• Provides oversight and guidance to clinical operations personnel assigned to the clinical trial.
• Partners closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Safety, and other functions to ensure aligned and efficient trial execution.
• Establishes strong relationships with investigators and KOLs.
• Contributes to the development and review of key study documents including protocols, ICFs, monitoring plans, EDC specifications and statistical analysis plans.
• Contributes to the selection of vendors and CROs. Manages and oversees CROs, vendors, and other external partners to ensure high-quality performance and adherence to expectations.
• Develops, manages, and tracks clinical trial budgets, ensuring studies are delivered within approved financial parameters.
• Provides regular, clear updates on study status, risks, and milestones to senior leadership and key stakeholders.
• Proactively identifies operational risks and implements mitigation strategies to maintain timelines, quality, and compliance.
• Supports and facilitates execution of contracts, clinical trial agreements, and study budgets.
• Direct manager of approximately 1-2 direct reports.
• Provides expert input into the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
• Drives the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
• Fosters a highly collaborative culture and serves as a leadership role model within the company and with external stakeholders.
• Complete other duties as assigned by the manager.

JOB SPECIFICATIONS:

• Bachelor’s degree in science/healthcare field, a nursing degree, or equivalent combined education.
• 10+ years of strong hands-on experience leading large, complex Phase 3 clinical trials preferably in oncology/hematology in US, Asia, Europe; or equivalent combination of training and experience.
• Proven ability to build strong relationships with external partners, CROs, and vendors including extensive experience managing contracts and clinical finance activities.
• In-depth, working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent verbal and written communication skills.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Flexibility to travel domestically and internationally as required.
• Experience with Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
• Experience setting up clinical trials outside of US and Europe is a plus.
• Field monitoring and/or clinical data management experience preferred.
• Proficiency with Microsoft Project

The base range for a Director is $228,000 - $252,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

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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

• Career advancement/ development opportunities
• 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. 

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