Director, Clinical Systems

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:

Key Responsibilities include leading, defining, directing, and managing the clinical systems strategy and function.  Implement  GxP clinical systems and associated processes including maintaining systems in a validated state; facilitation of requirements gathering and user acceptance testing; validation plans and activities; procedural document creation; system release; and subsequent change management. Promote systems innovation and compliance through strategic recommendations, implementations, and lifecycle management.  Establish and maintain processes, tools, and training to support inspection readiness and compliance.   Provides strategic direction and direct ownership for one or more clinical systems.

• Define, develop, and execute roadmap and strategy for management of existing clinical Systems and integration of new systems.
• Responsible for lifecycle management of clinical systems and management of assigned Business Systems Owners within Clinical Systems.
• Evaluate and optimize processes for Computer Software Assurance (CSA) ensuring that Kura’s framework takes a risk-based and fit-for-purpose approach to systems implementation in partnership with Information Technology (IT) and Quality Assurance (QA).
• Work with stakeholders and assigned business system owners (BSOs) and functional system owners (FSOs) to identify and implement system enhancements, including system configurations, and optimizations to controlled documentation and/or business processes.
• Monitor current and emerging industry and health authority regulations and guidance for systems and technology, including Artificial Intelligence and changes to CSA, and partner to integrate with Kura’s processes.
• Serve as a member of the IT Steering Committee, reviewing business-proposed systems and evaluating business need, GxP applicability, and timing of project launch/completion.
• Responsible for validation of systems implementations, including: project management; facilitation of requirements gathering and testing; creation of validation documentation including traceability matrix, validation summary plan and report; and that governing procedures are in place for access and use.
• For production systems, maintenance of validated state in accordance with internal change control procedures and regulatory expectations. Includes activities such as impact assessment for planned and unplanned system releases.
• Supervise and support reporting BSO’s to ensure adherance to Kura’s CSA procedures for system evaluation, implementation, validation, maintenance, and retirement. Includes items such as user access processes, controlled document management and maintenance, change controls, periodic review, and inspection readiness. 
• Ensure that where BSOs are also FSOs for a system, that those processes are followed, including items such as creating and distributing metrics, maintenance of operational business processes, stakeholder engagement, training development and distribution.,
• Evaluate and assign resources based on system roadmaps, BSO responsibilities, and complexity/criticality of system(s).
• Will have functional and line management responsibilities for staff.
• Complete other duties as assigned by manager

JOB SPECIFICATIONS:

• A./B.S. degree in Biology, Computer Science, or related field. Advanced degree preferred. 
• 10+ years’ experience in Clinical Operations, IT, or related function in a biopharmaceutical setting.
• Extensive experience in computer system validation and/or computer software assurance processes for GxP governed clinical systems required.
• Prior line management experience required.
• Previous experience functioning as a system administrator or similar role for GxP systems required.
• Experience with GxP Veeva platform strongly preferred.
• Excellent planning, organization, time management, and communication skills required, including the ability to support and prioritize multiple cross-functional projects simultaneously.
• Must have the ability to communicate complex material to all levels of the organization while tailoring to experience and knowledge of the recipients.
• Flexibility to travel up to 5% of the time.

#LI-RM1

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 discovering and developing personalized therapeutics for the treatment of blood cancers and solid tumors. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is 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. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). 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.