Kuraoncology · Boston, MAPrepare for this interview
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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: Responsible for leading and developing the clinical drug supply strategy, planning and management of all supply chain activities required to support global Phase I - III clinical studies including forecasting, supply planning, IRT configuration, inventory management and CMO management Collaborate with the Clinical Development and Clinical Operations teams from protocol development through final study design to have an in-depth understanding of the clinical study requirements and assumptions needed to set up the supply chain required to support the execution of the study and develop the IP forecast Participate in Clinical Sub Team (CST) meetings, Study Team meetings, Project Team meetings and present Supply Chain updates as required to the Kura cross-functional team Develop an expert-level understanding of the IRT system used to manage site activation, IP site shipments, monitor patient enrollment, patient visits, determine trends and execute adjustments Manage extensive internal and external touchpoints and maintain close communication and collaboration to ensure adequate clinical drug supply for multiple global clinical trials while ensuring compliance with cGMP and global regulatory requirements Responsible for providing commercial supply chain support in collaboration with the Manufacturing, Quality and the Commercial team including serialization expertise, as well as the release and distribution of commercial product from 3PL to authorized trading partners in compliance with the Drug Supply Chain Security Act (DSCSA) Participate in the creation and maintenance of clinical and commercial SOP's and Work Instructions and related documentation Lead continuous improvement initiatives in collaboration with the IMSC team, as well as cross-functional partners to document, standardize and streamline core supply chain processes supporting Kura's clinical programs, as well as the commercial supply chain Support financial planning for global clinical studies including budgeting, forecasting and strategic planning activities Job Specifications: Technical degree or equivalent (BS/MS), preferably in Supply Chain or IT A minimum of 10-12 years pharmaceutical/biotechnology supply chain planning and forecasting experience, preferably in a manufacturing or commercial environment 3- 5 years of leadership experience in pharmaceutical/biotechnology industry with a proven track record of leading teams and delivering results Experience managing complex global supply chain operations including vendor partnerships, contract negotiations, while ensuring compliance with cGMP regulations and requirements Experience collaborating with Manufacturing, Quality and CMO's including providing a 12 - 24 month rolling forecast of drug product requirements, managing production schedules and coordinating FG deliveries Comprehensive knowledge of CMC requirement/activities including development, validation, regulatory and quality requirements and timelines Owns decision making for their functional area or program, including resolving complex issues and making trade-offs to achieve program objectives, with minimal escalation. Leads cross-functional collaboration for assigned programs, proactively driving alignment across stakeholders and resolving issues to support program execution. The base range for a Director is $202,000 - $235,672 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. #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 oth
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