Manager/Senior Manager, Clinical Supply Chain Planning/Logistics Management
San Diego, CA, United States
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
Act as the lead Clinical Supplies representative on specified project/programs including protocol review and input, developing supply chain and labeling strategy and delivering key input to the overall demand and forecasting scenario planning.
Work cross-functionally with multiple departments to support on-going and planned deliverables and projects.
Experience in procurement and labeling strategy for comparators and combination therapies.
Comprehensive global label generation requirement including text and label proof generation and approval processes.
Pre and post vendor batch record review and approval process
Standard Operating Procedure (SOP) creation, updating and training, new SOP training. This also includes the same for Work Instruction (WI)
Concise records keeping including genealogy tracker.
Purchase Order creation and update for approved SOW/CO's including invoice review for accuracy and approval, working with Finance on budget creation/maintenance and Insurance review and updates.
Comprehensive knowledge of IVRS/IRT systems including executing all appropriate IRT review and maintenance, URS and UAT generation and execution, testing and approval.
Job Requirements
Bachelor's degree, RN, or equivalent, preferably in a scientific or pharmaceutical discipline
5+ years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
Understanding and execution of vendor management capabilities in a 100% virtual environment. Keen negotiating skills, keeping vendors on track with deliverables and timelines.
Strong knowledge of Logistics; Global coordination of shipments including freight forward and customs broker arrangements involving, but not limited to samples, RSM's, API, DP finished goods, etc.
Fundamental knowledge of inventory management and forecasting systems and Clinical Trial supply processes
Working knowledge of Clinical Trials and the Clinical Trial Supply process
Proactively identifying potential issues, develop mitigating actions and notifying appropriate personnel in a timely manner
Hold a fundamental understanding of ICH guidelines, GCP's, 21 CFR and Annex 13 requirements
General working knowledge of essential computer applications (i.e. MS Word, Excel, PowerPoint, MS Project) and working knowledge of IVRS systems
Ability to influence others
Ability to multi-task
Excellent verbal and written communication skills
The base range for a Manager is $135,000 - $154,000 and Senior Manager is $140,000- $150,000 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
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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