New

Mgr/Sr. Mgr., Clinical Systems

Kura Oncology
401(k), stock options
United States, Massachusetts, Boston
2 Seaport Lane (Show on map)
Jan 31, 2025
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. Assist in the establishment/execution of Kura's document management strategy to provide instream inspection readiness Independently manage the operation and strategy of moderately complex GxP clinical systems, including maintenance of the validated state of the system. Work with study team functions to monitor TMF metrics (completeness, accuracy, quality), and work with teams to understand and improve metrics as needed Accountable for developing reports and dashboards within the Veeva Vault eTMF and other systems, and maintaining access list for reports Serve as a SME for system enhancements, releases, integrations, and general functionality Support Clinical System day-to-day tasks, including user creation and account management, help requests, audit support, and other regular support tasks Accountable for internal training with respect to TMF filing of documentation and general system usage, and creation/maintenance of other training as required Assist study teams in Sponsor Oversight QC (SpOQC) and workflows management Independently execute validated system change controls, including performing testing and vetting changes and documentation with QA and IT Responsible for the creation, maintenance, and archival of records and metadata within Kura's Veeva eTMF Develop and/or review Clinical Systems controlled documentation or other areas as needed Work with stakeholders to identify and implement opportunities for improvements to systems and/or processes Monitor system and process health, communicating outwards as relevant Manage study team training processes and modules, including curriculum development and completeness/timeliness tracking Under Kura's Computerized System Validation (CSV) process, participate in the implementation of validated systems, including project management, document creation, and workflow management 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) Technical knowledge of global TMF document management with solid understanding of the CDISC Reference Model Experience with Veeva's eTMF Vault required (3+ years) Experience with Saama's Data Visualization, Egnyte platform, validated SAS, and/or Veeva Study Team Training systems a plus Computerized Systems Validation (CSV) experience a plus Experience in managing sponsor TMF requirements, as well as managing vendors working in a sponsor TMF 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 atwww.kuraoncology.comand follow us onXandLinkedIn. 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.