Clinical Supply Chain & Logistics Manager

Summary: As the Clinical Supply Chain & Logistics Manager, you will manage drug, intermediates and samples between external partners for our upcoming nonclinical studies, clinical trials, and analytical testing. In this highly visible role, the successful candidate will interface with a diverse team across Clinical Development, Clinical Operations, Clinical Supply Chain, Finance, Manufacturing, Quality, and external partners to support key tasks related to planning, shipping & logistics, labeling, packaging, distribution, and inventory management of investigational materials. We are looking for a professional who has extensive experience in the biotech/pharmaceutical industry, and who has specific experience in Global Import/Export logistics.

  • Manage the day-to-day distribution activities with all third-party service providers including booking and tracking of Drug Product shipment to support uninterrupted supply to clinical trials
  • Establish shipping lanes and logistics processes for new clinical trials or new clinical sites including preparation of shipping, importation and exportation documents
  • Coordinate the resolution of sample and product shipment delays and deviations with vendors, internal teams and partners. Proactively identify potential shipment delays and escalate as needed. Perform root cause analysis of shipping issues in order to identify process improvements
  • Serve as the single point of contact to key stakeholders for logistics topics
  • Provide a responsive, effective and successful high level of customer service to Clinical Operations, CMC and Nonclinical partners.
  • Participate in cross-functional distribution related projects and process improvement initiatives.
  • Enhance delivery of Akero’s CMC objectives by fostering strong CMO/CRO relationships
  • Use key project management tools to plan and track project deliverables.
  • Participate in CMC Team meetings and provide logistics and supply updates to CSO and CDO
  • Facilitate tracking of the movement of drug, intermediates and samples for analytical testing between external partners
  • Analyze shipping temperature monitoring data and participate/lead investigations for excursions, in close collaboration with Quality
  • Interface with the CMC Project Manager to ensure planning, coordination and communication to enable timely supply of materials.
  • Assist Heads of Process and Product Development, and Financial Controller in CMC project budget planning and tracking, including invoice payments, accruals and reforecasting as needed.
  • Assist COO-General Counsel and VPs Process and Product & Device Development in circulating RFPs, establishing contracts, amending and approving work programs.

Technical Requirements & Skills

  • Agile learner, able to move effectively between detail and project strategy
  • Demonstrated ability to work in teams, to build strong relationships and to lead by influence. Sophisticated interaction style across cultures.
  • Adaptable and flexible team-player comfortable with ambiguity in fast-moving, dynamic environments
  • Excellent project integration, planning, communication and documentation skills. Familiarity with planning tools (Microsoft Project, Excel, PowerPoint and Outlook).
  • This position is located in South San Francisco, California and may require domestic or international travel as required (valid travel documents must be obtainable).

Qualifications:

  • S. degree in a scientific discipline or management
  • Minimum 3-5 years of experience in logistics and/or supply chain discipline. Experience with temperature sensitive product logistics and transportation preferred
  • Experience managing projects with remote teams and through external alliances preferred
  • The successful candidate will work well in teams, both local and in the global community, influence without authority, be well organized, learn quickly and be highly accountable. Further, the successful candidate will have demonstrated effective communication with management, peers, customers, and vendors, have an ability to prioritize and organize with minimal supervision.
  • Experience in the exportation and importation of human biologic samples and investigational drugs preferred
  • Demonstrated communication and collaboration skills within cross-functional teams
  • Excellent verbal/written communication skills, with the ability to positively influence key decision-makers
  • Ability to successfully manage competing priorities
  • Problem-solving skills, with the ability to anticipate problems, recommend solutions and implement
  • Ability to work flexible hours to meet global requirements as they arise