Sr Mgr/Associate Director, Clinical Demand Planning & Forecasting

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 drug supply planning strategy and overall management of all aspects of drug supplies (IP) for global FIH – Phase I - III clinical studies as the leader of Investigational Medicinal Supply Chain (IMSC).
• Must be flexible and agile to review, determine and execute the impact of protocol design changes, whether before study launch or during study execution and relay the impact to IMSC, CMC and other key customers.
• Understand and incorporate non-clinical demands into overall Demand Planning and Forecasting output, to support approved requirement like but not limited to Investigator Sponsored Studies (ISS), Early Access Programs (EAP), Compassionate Use (CU) etc.
• Responsible for providing strategic leadership of IMSC Demand Planning and Forecasting, and demonstrating operational excellence and interdependent workflows with CMC, Analytical Development, Quality Assurance, etc.
• Establish operating policies and procedures and provide comprehensive coordination of complex global supply chain operations, inventories, materials, and procurement while ensuring compliance with regulations and guidelines.
• Maintain expert-level understanding of IRT systems, to monitor on-going protocol enrollment, issuances, time-on-therapy to verify actuals versus projections, determine trends, execute adjustments, and communicate and changes to deliverables promptly and concisely.
• Manage extensive internal and external touchpoints and maintain close communications with all IMSC groups to ensure the adequate supply of clinical supplies throughout the duration of multiple WW clinical trials including oversight of drug order requests, resupply, and processes.
• Contribute and participate in the upkeep and maintenance of IMSC as it relates to SOP, Work Instructions and other key processes and procedures.

JOB SPECIFICATIONS:

• 6-10 years pharmaceutical/biotechnology clinical supply chain demand planning and forecasting for multiple compounds ranging from First In Human (FIH) to Phase III in a global environment.
• 6-10 years pharmaceutical/biotechnology experience in comparator/combination/co-therapy demand planning. This would include multiple therapies and formulation/packaging options in a global setting.
• Extensive experience in dealing with co-therapy procurement vendors and establishing strategy for purchases.
• Comprehensive knowledge of Drug Substance and Drug Product manufacturing systems/processes and being able to relay planning information clearly and concisely to those key customers to maintain a seamless manufacturing environment.
• Comprehensive knowledge of CMC requirement/activities that do not involve clinical supply chain (validation/development/Commercial etc.) to provide timelines that are attainable while allowing CMC to meet their other deliverables.

The base range for a Senior Manager is $134,875 - $158,079 and an Associate Director is $156,750 - $186,954 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 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<