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Kura Oncology, Inc. · 1 day ago

Director, Supply Chain

Boston, MA

Full-time

Onsite

Director/Executive

$202K/yr - $236K/yr

8+ years exp

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Director of Supply Chain will be responsible for leading and developing the clinical drug supply strategy and managing all supply chain activities required to support global clinical studies.

BiopharmaBiotechnologyGeneticsHealth CareMedicalOncologyPrecision Medicine

Comp. & Benefits

Responsibilities

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

Qualification

Supply Chain ManagementClinical Drug Supply StrategyPharmaceutical ExperienceCGMP ComplianceForecastingLeadership ExperienceContinuous ImprovementCollaboration SkillsCommunication Skills

Required

Technical degree or equivalent (BS/MS), preferably in Supply Chain or IT

8-10 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