Manager/Senior Manager, Clinical Data Sciences

Manager/Senior Manager, Clinical Data SciencesAre 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.Key responsibilities include oversight of outsourced data management & EDC activities by service providers, performing and coordinating internal study team data review, and delivery of fit for purpose clinical data in support of study milestones.Essential Job Functions:Provide clear, consistent communication to Kura's CROs and 3rd party Vendors with respect to data management deliverables and monitor performance against communicated expectations.Coordinate internal team review and feedback during EDC builds and/or migrations and provide clear guidance to external DM and EDC build team throughout.Accountable for DM task and milestone timelinesResponsible for ensuring data quality and integrity for clinical study data collection activities.Work with clinical team to define and maintain the Kura Comprehensive Data Review Plan.Lead Kura study team in the review of clinical study data per Comprehensive Data Review Plan.Prepare and provide internal data listings and reports as required.Review protocols for data collection and management feasibility.Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).Review study budgets and provide input on data collection, cleaning, and reporting as it relates to development of vendor contractsPartner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.Responsible for tracking and documenting data management decisions.Responsible for initiating and chairing meetings associated with assigned studies and initiativesProvide support and contribute to the development of clinical trial timelines as it relates to data management activities.Manage accruals tracking and vendor payments for data management activities.Contribute to the development of departmental procedures documentation.Complete other duties as assigned by theJob Specifications:A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field.5+ years' experience in data management or relevant work in the pharmaceutical/biopharma industry.Experience in oncology strongly preferred.Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out)Significant experience providing oversight for database migrations.Experience with an NDA submission desirableStrong project management skillsStrong vendor management skills (e.g. Biomarkers, Labs, Imaging, ECG).Able to provide independent DM subject matter expertise to study teams and vendors in defining, managing, & delivering on DM obligations.Experience working in 1 or more EDC platforms (Rave, InForm, etc.).Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirableSolid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.Excellent interpersonal skills in addition to verbal and written communication skills.Strong Excel skills, SAS experience a plusFlexibility to travel up to approximately 5% ofThe base range for a Manager is $150,000 - $180,000 and for a Senior Manager it's $178,000 - $213,000 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.Kura's Values:We work as one for patientsWe are goal-focused and deliver with excellenceWe are science-driven courageous innovatorsWe strive to bring out the best in each other and ourselvesThe Kura Package:Career advancement/ development opportunitiesCompetitive comp packageBonus401K + Employer contributionsGenerous stock optionsESPP Plan20 days of PTO to start18 Holidays (Including Summer & Winter Break)Generous Benefits Package with a variety of plans available with a substantial employer matchPaid Paternity/Maternity LeaveIn-Office Catered lunchesHome Office SetupLifestyle Spending StipendCommuter Stipend (Boston Office)Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much moreKura 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