Drug Supply and Logistics Coordinator

Full Time
Blacksburg, Va
Posted 2 months ago

Position Summary:

The Drug Supply and Logistics Coordinator position will support daily logistics operations, manage relationships with transportation providers, and handle invoice creation for logistics. Experience working in the biotech/pharmaceutical industry is required. This candidate will provide strategic direction for clinical supply chain planning activities for assigned programs and will be competent in developing a program level supply plan for new and ongoing studies to ensure sufficient supply on a global level. This position will work closely with the Executive Vice President of Operations and Regulatory Affairs and other Landos team members to meet clinical deadlines and company goals. A wide degree of creativity and latitude is expected. Must have excellent oral and written communication skills. The role is based in a highly sensitive, fast paced environment, demanding flexibility and accuracy, while in compliance with International/Federal/State regulations.

The candidate will be completely aligned with the four fundamental pillars of Landos’ entrepreneurial and efficient corporate culture: 1) Be bold and decisive, 2) Never give up, 3) Be solution-oriented, and 4) Do the impossible.

Key Responsibilities:

  • Creating export and import documentation in support of movement of drug substance, drug products, and finished goods
  • Supporting internal and external customers by providing timely status updates on domestic and international shipments
  • Coordinating internally with finance and business partners, freight forwarders, and 3PLs for timely and accurate shipment releases and deliveries
  • Working with carriers to schedule shipments, track shipment status, and provide timely PODs
  • Performing required inventory transactions in the ERP system
  • Developing/managing record keeping and audit processes
  • Participating in carrier evaluations and business reviews
  • Supporting Logistics with daily operational activities including training as required
  • Collecting, analyzing, and reporting data and working with carriers and internal partners to create meaningful metrics and KPIs
  • Performing monthly analysis of shipping data and reporting to management
  • Performing trending analysis and own related reports, identifying necessary corrective actions and driving implementation
  • Interpreting INCOTERMS and providing advice to the business
  • Completing all daily operations in compliance with all International/Federal/State regulations
  • Works cross-functionally as part of a dynamic team across clinical operations to manage end-to-end clinical drug supply chain availability for assigned projects.
  • Responsible for the set-up and coordination of project activities related to clinical and ancillary supplies.
  • Independently support the delivery of the Clinical and Ancillary supplies component of assigned studies within a region or for a large global study.
  • Ensures that clinical trial materials are available for patients participating in clinical trials by analyzing current and forecasted material usage and projecting inventory availability across the clinical trial supply chain.
  • Formulates recommendations that ensure continuity of supply and communicating those recommendations with all key personnel involved with the packaging, distribution and storage of the clinical trial materials
  • Monitors inventory levels at the study depots and performs calculations necessary that support appropriate action to ensure that depots are appropriately stocked. Analyzes clinical supply material levels at sites and triggers manual shipments as required.
  • Coordinates label design and translation activities in accordance with the study project plan
  • Manages inventory, and shipment delivery of clinical trial materials and works with appropriate internal and external parties to address any issues which might impact the timely delivery of supplies to distribution depots and clinical trial sites
  • Collaborates with project team to complete and document User Acceptance Testing for Interactive Response Technology (IRT) systems.
  • Monitors and manages temperature excursions of clinical trial materials according to client expectations; ensuring that both internal and external personnel are aware and takes appropriate measures appropriately disposition or replace impacted product so that patients are not impacted.
  • Coordinates return, destruction and completes reconciliation of drugs on assigned studies and proactively escalates issues to appropriate parties.
  • Documents and maintains calculation of drug use and supply based on varying levels of available data from Landos, IRT vendors, Sites, Depo and CROs.
  • Identifies and/or recommends process improvements based on understanding of clinical trial supply chain management best practice principles and appropriately documents and revises or develops associated training materials.
  • Works with both internal and client Project teams to ensure consistent communication of clinical trial material supply status and potential risks. Produces reports and metrics as agreed for study tracking.
  • Leverages the inventory management capabilities of the Interactive Response Technology (IRT) to manage site and depot inventories, releases depot shipments and follows-up on any site shipments not received
  • Attends relevant client-related meetings and appropriately represent status of the Clinical Supply Chain
  • Maintains documents according to guidelines and relevant procedures
  • Identifies strategic direction and optimal supply strategy aligned with pipeline goals.
  • Develops the program level demand planning forecasts and budgets based on the book of work for clinical drug supplies through all phases of clinical development for assigned programs. This includes providing to key stakeholders: study cost estimates, monthly budget projections, demand requirements and timing for drug substance and drug product for the manufacture, as well as packaging, labeling, and release for finished goods for delivery to the warehouse depots in time for study needs.
  • Reviews real-time, comprehensive study level demand projections for ongoing studies on a monthly basis. Incorporates new future study demand and uses this comprehensive view to exercise judgment to influence and prioritize manufacturing and purchasing decisions. Adjusts the Program supply plan for new study demand requirements.
  • Participates in proactive discussions and decisions regarding adjustments to the Program supply plan as needed during team meetings.
  • Adjusts budget as required in response to changing study needs.
  • Actively participates in clinical study team and various development and operations meetings by providing feedback across functional areas when required from a clinical supply perspective. Identifies potential risks and escalates to the appropriate stakeholders as needed.
  • Plans for excipients/ancillary supply for studies involving on-site compounding. Interfaces with Integrated Supply Chain to ensure the availability of appropriate quantities and dating for excipients as needed.
  • Works with the labeling group to prepare initial packaging and labeling options and communicates these options to the clinical leader for negotiation and finalization for optimal study dosing.
  • Acts as the primary Drug Supply liaison for collaborations with Contact Research and Manufacturing organizations (CRO’s and CMOs), drug sourcing vendors and other strategic alliance partners. Reviews and provides feedback to drug supply sections of collaboration agreements, and liaises with direct supervisors and Legal to develop and finalize Clinical Supply Agreements when required.
  • Performs various tasks related to study implementation which includes but is not limited to: providing input to the clinical protocol, the final Clinical Study Report, generation of justification memos, purchase requisitions, independent requirement orders, and packaging specifications for planning and release of drug supply and comparators in time to meet the study timelines.
  • Attends Global Clinical Trial Unit submission tracking meetings. Where required, provides input for regulatory documentation and provides feedback to address responses to Health Authority requests. Submits Tracking and Notification for drug related changes to manufacturing, packaging and labeling as required.
  • Reviews and provides input and approval for set up of user requirement specifications.  Interacts with vendors, CRO, CSO Logistics and internally with the clinical study team to ensure optimal operation.
  • Maintains the strictest confidentiality of all activities.
  • Team player, engendering credibility and confidence within and outside the company.
  • Faithfully performs any other tasks requested by the Chairman, President & CEO.
  • Act in accordance with Landos’ policies and in alignment with the corporate culture.

Apply Online

A valid email address is required.
A valid phone number is required.