Sr. Manager/Associate Director CMC Demand Planning & Vendor Management

Job Description

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 developing all elements of drug supply inventory management and planning activities including key raw materials, regulatory starting materials, drug substance intermediates, API, drug products, and packaged goods
  • Coordinate and maintain the CMC manufacturing supply chain network and operations for the commercial and 3PL business interface.
  • Responsible for the overall logistics management elements for both clinical and commercial supply and delivery
  • Coordinate drug supply delivery timelines with CMC Manufacturing, Commercial and Clinical; includes Packaging, Labeling, and Distribution CRO's
  • Monitor and track global supply chain inventory for clinical studies; maintain and coordinate manufacturing with commercial forecast requirements, demand planning.
  • Maintain close communications with all internal supply chain groups to ensure the adequate supply of product throughout the duration of multiple clinical studies and commercial forecasts
  • Serve as knowledgeable resource for managers throughout the organization on issues related to investigational and commercial products
  • Support financial planning for commercial demand and global clinical supplies, including budgeting, forecasting, and strategic planning activities and drug distribution with finance
  • Other duties as requested by supervisor

Job Requirements

  • Bachelor's degree, or equivalent, preferably in a scientific or pharmaceutical discipline
  • 5+ years of prior experience in a pharmaceutical, biotech, and supply chain logistics environment preferred
  • Fundamental knowledge of inventory management, database management, and forecasting systemsfor both Clinical Trial and Commercial supply sourcing networks
  • Working knowledge of demand planning, supply chain network coordination, and third party logistics and serialization processes
  • Proactively identifying potential issues, develop mitigating actions and notifying appropriate personnel in a timely manner
  • Hold a fundamental understanding of ICH guidelines, GXP's, 21 CFR and Annex 13 requirements as well as import/export and customs requirements
  • General working knowledge of essential computer applications (i.e. MS Word, Excel, PowerPoint, MS Project, Smart Sheets) and a working knowledge of IVRS systems
  • Ability to multi-task
  • Excellent verbal and written communication skills

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
  • Bonus
  • 401K + Employer contributions
  • Generous stock options
  • ESPP Plan
  • 20 days of PTO to start
  • 18 Holidays (Including Summer & Winter Break)
  • Generous Benefits Package with a variety of plans available with a substantial employer match
  • Paid Paternity/Maternity Leave
  • In-Office Catered lunches
  • Home Office Setup
  • Lifestyle Spending Stipend
  • Commuter Stipend (Boston Office)
  • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company's diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology's approach to drug development is focused on rapidly translating novel science into life-saving medicines. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura's pipeline consists of three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at www.kuraoncology.com.

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 to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

 

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