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.
Senior Director, Clinical Supply Chain
We’re looking for an innovative Senior Director, Supply Chain to join our growing team! This position will report to the Vice President, Manufacturing & Supply Chain. This is a newly created position due to growth.
ESSENTIAL JOB FUNCTIONS:
- Responsible for leading and developing drug supply planning strategy and overall management of all aspects of drug supplies (IP) for global Phase I – III clinical studies as the leader of Investigational Medicinal Supply Chain (IMSC).
- Responsible for providing strategic leadership of IMSC and demonstrating operational excellence in developing, and executing interdependent workflows with Clinical Operations, Quality Assurance and Global Project Team management to ensure successful Drug Development Activities are achieved across all areas of IMSC deliverables.
- Contribute vital tactical support and leadership in supply chain and logistics management while identifying and pursuing strategic opportunities to improve IMSC capacity, forecasting & planning models, IP materials and processes, IVRS Management, and overall IMSC performance and efficiencies.
- Establish operating policies and procedures and provide comprehensive coordination of complex global supply chain operations, inventories, materials, and procurement while ensuring compliance to regulations and guidelines.
- Coordinate drug supply delivery timelines with Clinical and CMC; Packaging, Labeling, and Distribution CRO’s; and indirectly with GMP manufacturers, QA, and Regulatory Affairs,
- Lead the team in monitoring and tracking global clinical supply inventories at the clinical site level for studies; maintain forecasts and provide inventory and logistics management of IP adjusting drug distribution plans with coordination of packaging, labeling at Contract Packaging Vendors.
- Provide IMSC project leadership and management, and act as knowledgeable resource for establishment of effective collaboration with Clinical Operations for seamless delivery of IP to patients worldwide.
- 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.
- Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials; and reconciliation of drug distribution invoices with finance staff to maximize productivity, efficiency, and overall business performance.
- Contribute and review the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinate the origination, proofing and translation of clinical study labels and generation and updating with quality assurance all IMSC related SOP’s.
- Technical degree or equivalent (BS / MS), preferably in a scientific or pharmaceutical discipline
- 10+ years of prior experience in a pharmaceutical, biotech and demonstrated leadership of a clinical supply organization is required.
- Lead strategic, operational and compliance related areas of IMSC governance and in accordance with organizational directives and regulations, execute on corporate goals and objectives.
- Lead the department to improve productivity and efficiency while reducing operating costs.
- Contribute and review the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, as necessary.
- Fundamental knowledge of inventory management and forecasting systems, IVR systems, and Clinical Trial Supply processes is required.
- Provide leadership and oversight in monitoring inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues.
- Proactively identifying potential issues, develop mitigating actions and notify Executive Management in a timely manner.
- Collaborates with Quality Assurance, cGMP and cGCP Compliance Specialists and Subject Matter Experts, and maintains a strong understanding of Global Health Authority regulations for packaging, labeling, systems, distribution, and vendor management is required.
- Provide interpretation of regulatory guidance documents, regulations and directives and advising regarding their applicability and impact on internal labeling programs.
- Create, develop, review, and revise clinical supplies SOPs.
- 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 extensive knowledge of IVR systems.
- Oversight for requirements, review, and approval of IVRS specifications from investigational materials perspective, oversee UAT.
- Ability to influence and lead others in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies.
- Ability to multi-task effectively with strong organizational and leadership skills.
- Excellent verbal and written communication skills.
THE KURA PACKAGE
- Career advancement/ development opportunities
- Competitive comp package
- 401K + Employer contributions
- Generous stock options
- ESPP Plan
- 20 days of PTO to start
- 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
- 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
- Cell Phone and Wellness 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 Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.
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. To apply, please submit your resume to firstname.lastname@example.org