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Senior Director, Global Clinical Supply Chain

Umoja Biopharma

Umoja Biopharma

Sales & Business Development, Operations
Louisville, CO, USA
Posted on Saturday, May 25, 2024

Umoja Biopharma is a game-changing biotech start-up with locations in Seattle, WA and Louisville, CO, focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. Our vision is to develop off-the-shelf therapies capable of treating any tumor, any time. We are a diverse and growing team working in brand-new facilities in downtown Seattle, Washington, and Louisville, Colorado, and we are looking for innovative thinkers who are excited by groundbreaking science and technology, and passionate about squaring up to the challenges inherent to cutting edge drug development. We are committed to the principles of Diversity Equity and Inclusion and strongly invite applications from enthusiastic individuals who share our commitment and help position Umoja as a leader in this front.

We at Umoja believe in the importance of stories; we are looking for great people to join our team to help us create more stories for ourselves, for you, and most importantly for patients and their families.

Umoja Biopharma – Your Body. Your Hope. Your Cure.

POSITION SUMMARY

Umoja Biopharma is seeking a Senior Director of Clinical Supply Chain to join and support our Manufacturing team as well as the Clinical Operations team in ensuring the success of Umoja’s state-of-the-art lentiviral vector development and manufacturing facility in Louisville, CO. This role will report the SVP, General Manager of The CLIMB and will be responsible for providing the vision, strategy and leadership over global clinical drug product supply planning, warehouse and label/pack operations, distribution management, and logistics for Umoja’s clinical supply chain. This role will manage all clinical supply activities for both internal clinical studies and those with external partners in accordance with clinical study timelines.

This position will be based in Louisville, CO with the need to travel approximately 30% of the time to Seattle, WA and to visit CRO locations.


CORE ACCOUNTABILITIES

Specific responsibilities include:

  • Work closely with Clinical Operations, Regulatory, Quality, and other functions to identify study drug requirements, distribution warehouses, and import/export requirements
  • Collaborate with Clinical Operations to understand clinical demand requirements and ensures alignment with study teams on clinical supply plans and timelines.
  • Oversee the planning and warehouse operations team
  • Develop operational supply strategies to support UMOJAs entry into the global clinical supply landscape through internal development of capability and use of external partners.
  • Develop and maintain clinical supply forecasts for all programs
  • Draft and own documents, SOPs and MBRs used internally and own content for documents generated externally on UMOJA’s behalf
  • Manages clinical supply inventory, reviews inventory reports, and monitors upcoming retest/expiry dating for investigational products and co-meds.
  • Coordinate sourcing of co-meds working closely with procurement and supply vendors
  • Ensure delivery of co-meds to operations partners for packaging and distribution
  • Create and maintain demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance with the program requirements.
  • Initiate packaging campaigns with the assigned vendor and provide oversight to ensure on-time delivery
  • Interface with internal manufacturing and external vendors on related activities for distribution operations, providing robust solutions and implementation actions.
  • Act as point of escalation if deliverables and timelines are jeopardized, communicating to appropriate internal and external stakeholders as needed.
  • Ensure team supports QA and Legal in establishing QA and Master Services Agreements with all vendors and partners.
  • Monitor the supply strategy of the business including forecasting and communication with suppliers.
  • Interface with CRO to assure efficient and timely delivery of clinical drug supply to clinical trial sites
  • Participate in compliance audit process from planning through implementation, result evaluation, and response review.
  • Drive the close out of audit commitments and Corrective and Preventive Actions (CAPAs) as appropriate.
  • Oversee distribution and logistics teams for storage, import & export, distribution, product return, destruction, and depot management.
  • Accountable for ensuring successful delivery of drug product delivery to depots and clinical sites.
  • Develop and maintain relationships with global courier/broker vendors.
  • Oversee the development of the import permit application strategy globally.
  • Understand and oversee Import/Export requirements for all program country jurisdictions.
  • Ensure site/vendor metrics, key issues, production status, operational performance summary updates are tracked and reported by implementing key performance indicators (KPIs).
  • Provides financial reporting and reconciliation of inventories.
  • Participate and lead process/performance improvement initiatives cross functionally with stakeholders contributing to global/regional initiatives or programs.
  • Oversee the annual forecast and budgeting target vs. actual for clinical production management / drug product planning and distribution activities.
  • Responsible ensuring team supports investigation of exceptions to determine root causes, implement CAPAs and drive closure.
  • Ensure robust systems and processes are in place to enable execution of warehouse operational and logistical tasks in a cGMP compliant manner.
  • Participate in site visits as requested.

The successful candidate will have:

  • Bachelor’s degree and minimum of 15 years of global clinical supply chain experience in a cGMP environment
  • Minimum of 5 years of managerial experience directly managing people and leadership experience leading teams, projects, and programs and directing the allocation of resources. Equivalent combination of education and experience will be considered.
  • Minimum 5 years’ experience with cGMP Global Clinical supply chain management operations including warehouse and inventory management, distribution, global labeling, packaging, jurisdictional material control and associated quality management processes.
  • Strong ability to collaborate and build strategic relationships with internal (Clinical Operations, Quality, CMC, Regulatory, etc.) stakeholders
  • Experience in 3PL and CMO vendor oversight and managing external partnerships and relations in all regions of the world.
  • Minimum of 7 years’ experience negotiating and interacting with business entities and regulatory agencies.
  • Demonstrated understanding of supply and capacity planning, logistics, engineering, maintenance, projects, safety, and SAP

Preferred Qualifications:

  • Manufacturing and/or ERP system startup experience
  • Knowledge of global clinical trials and the drug development process
  • Competence with computers and technology is essential; to include extensive experience with MS Office applications is required
  • Strong organizational, analytical, problem solving, and communication skills
  • Must be a dependable self-starter and be capable of working independently on multiple projects with the ability to prioritize tasks and meet deadlines
  • Knowledge of IRT system set up and functionality desirable
  • Knowledge of global pharmaceutical regulatory requirements (e.g. cGMP, GCP)

Salary Range: $233,000 - $282,500

Benefits Offerings

Umoja Biopharma offers its employees competitive Medical, Dental, and Vision plans. Additionally, we offer Umojians access to a 401k plan through Fidelity, with a 100% match up to their first 6% deferral. Umoja also provides a generous Paid Time Off policy, employee commuter benefits, and cell phone stipend. For a full breakdown of our benefits offerings, please see the Benefits section of our website.