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Senior Clinical Trial Leader

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Boston, United States Kura Oncology Full time

Senior Clinical Trial LeaderAre 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:General:Responsible for the planning and management of the operational aspects of clinical trials, including CRO and vendor management/oversight, ensuring project milestones and objectives are met and clinical study deliverables are consistent with program/company goals.Collaborate with internal and external team members for the planning and execution of clinical trials.Accountable for coordination of planning, initiation, completion, and reporting of clinical study protocols within or across programs from team endorsement to reporting.Ensure clinical trials meet time, quality, and cost targets consistent with the overall Clinical Development Plan.Lead the development of and provide input into study-related documents, including ICFs, CRFs, monitoring plans, study, lab and pharmacy manuals, data management plans, etc. Also performs review and provides strong operational input in the development of clinical trial protocols and CSRsContribute to department documentation development, such as the development and writing of Standard Operating Procedures (SOPs).Collaborate with Legal & Clinical Contracting & Outsourcing (and others, as needed) on the development and management of study specific agreements/budgets (i.e., non-disclosure agreements, clinical trial agreements, clinical research organization agreements, etc.).Organize and manage project timelines and budgets; help ensure project deliverables are on time and within budget and amended accordingly.Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the business financial standards.Oversee the conduct of studies and ensure studies are implemented according to the study protocols and in compliance with local, ICH, GCP and company policies and procedures.Monitor and visit clinical study sites as needed.Track, collect, and review clinical documentation for clinical trials.Complete other duties as assigned by the manager.Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Strategy Team (CST).Serves as the key CST point of contact for the trial.Accountable for the successful preparation and presentation of operational content at key leadership discussions (CST, GPT, SLT, etc.).Ensures strong oversight, review, and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.Accountable for partnering with CRO in audit responses and addressing quality issues.Filters, prioritizes, analyzes, and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.Ensures inspection readiness application for all assigned clinical trials.Sr. CTL:Manages projects/work streams with high complexity, risk, impact, and reach. Manages large-sized global clinical teams with members also from outside the direct working environment.Coordinates stakeholders from closely related areas and beyond.Demonstrates skills in successfully leading international teams in the matrix organization and directs, influences, and motivates people; creates and leads a positive working climate.Develop and lead operational and therapeutic area training for internal and external study team members.Directs multiple studies in parallel and/or be called upon for program management duties.Exhibits Subject Matter Expert level understanding of multiple functions and functional processes.Accountable for successful project execution including definition of milestones and clarification of project scope.Receives minimal guidance and works independently.Acts as a senior advisor and mentor within the team and beyond and serves as best practice resource within own discipline or as technical expert on cross functional teams or projectsJob Specifications:Advanced degree desirable; PM certification desirableIdeally 10 years clinical research experience with at least 5 years of direct trial management experienceSome experience in oncology preferred.Experience in CRO oversight is requiredManages large sized global clinical trial teamWorks with minimal or no supervisionAbility to mentor junior staffSelf-directed and proactive handles multiple complex tasksStrong organization, documentation, and communication skills.Excellent interpersonal skills: ability to collaborate across disciplines.Detailed knowledge of GCP, ICH Guidelines and current US FDA regulations.Ability to travel up to approximately 30% of time.Hybrid on-site in Boston two days per week.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,