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Senior Manager, Clinical Systems

Boston, MA

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 providing strategic and operational support for clinical systems.  Assist with delivering clinical operations system innovation and compliance through lifecycle support.  Establish and monitor processes, tools, and training to support GXP, good documentation practices and inspection readiness.

  • Independently manage the GxP validated implementation of moderately complex GxP clinical systems; manage validated operation and maintenance of implemented GxP systems. 
  • Work with system functional owners and stakeholders to determine system roadmap for improvements and/or optimizations, manage system releases, update controlled documentation and training materials, provide user support, manage user access, provide audit support, and other support tasks. 
  • Independently execute validated system change controls, including performing testing and vetting changes and documentation with QA and IT. 
  • Monitor system and process health, communicating outwards as relevant
  • Manage system training processes and modules, including curriculum development and completeness/timeliness tracking.

JOB SPECIFICATIONS:

  • Requires a Bachelor’s Degree or equivalent relevant experience in the field; 5+ years of experience (level will be determined based on experience and expertise); advanced degree preferred
  • Working knowledge of Computer System Assurance (CSA) principles and regulations
  • Experience with Computerized System Validation required (1+ years)
  • Experience with system administration of GxP systems (2+ years)
  • Experience with Veeva a plus
  • Solid planning, organization and time management skills including the ability to support and prioritize multiple projects; attention to detail is critical
  • Able to work on multiple high-priority projects and manage deadlines and deliverables
  • Excellent interpersonal skills, organizational skills, and written/verbal communication skills
  • Ability to tailor communications to the experience and knowledge of recipients
  • Solid understanding of clinical drug development process, regulatory requirements, and ICH/GCP guidelines
  • Flexibility to travel up to approximately 5% of time

 

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. 

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