Summary:

Vaxcyte is seeking a Sr. Manager, Clinical Supply, to lead clinical demand and supply planning, along with the planning and execution of clinical packaging runs. This role will be instrumental to ensure that our trials have sufficient vaccine and comparator supply to start as planned and continue to completion without any interruptions.

Essential Functions:

• Determine vaccine & comparator demand based on protocol, # of sites, shelf life, & risk.
• Translate demand plan into a supply plan (#, timing volume of packaging runs).
• Work closely with clinical secondary packaging sites, central and sub-depots and key stakeholders in Clinical Operations, Regulatory, Quality, Supply Chain, & Process Development to develop detailed project plan for each packaging run.
• Scenario planning based on potential different protocol designs or supply chain risks.
• Develop detailed project plan for each packaging run.
• Manage execution of packaging plan, and resolve / escalate issues as needed.
• Manage Clinically Labelled Drug Product label text/proof development, and Approval following regulatory guidelines, and in Veeva.
• Batch records pre-, and post-production review, and approval in Veeva.
• Collaborate with QA on central depot document management in Veeva.
• Partner with Clinical on IRT selection, implementation, and UAT.
• Manage cold-chain logistics for Clinically Labelled Drug Product.
• Inventory management for depots, and clinical sites.
• Monitor trial execution vs plan and drug shelf life and make adjustments to supply plan as needed to maintain supply continuity.
• Maintain Clinical supply dashboard and metrics.
• Maintain Batch Genealogy database.
• Resolve temperature excursions in storage depots, during shipping, and at clinical sites.
• Perform inventory reconciliation at end of trial.
• Ensure excess packaged inventory at end of trial is disposed of in a compliant manner.

Requirements: 

Bachelor’s degree in Life Sciences, Supply Chain, or Logistics; advanced degrees are a plus. 9+ years’ experience working in Clinical Supply Management. Other combinations of education and/or experience may be considered.

• Experience working with Blinded personnel and clinical supplies.
• Experience with vaccine trials highly desired.
• Experience with Veeva Vault highly desired.
• Experience with global regulatory labelling requirements for clinical trials.
• Working knowledge of current GMP.
• Experience with Cold Chain packaging, and logistics.
• Experience with Reverse Distribution, Accountability, and Destruction.
• Experience leading Cross-Functional teams.
• Good verbal and written communication skills.