Manager, Clinical Trial Supply

Company: Horizon Therapeutics
Location: Buffalo Grove
Posted on: June 18, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

Position Summary:

Reporting to the Senior Director, PD&T and CM&S, the Manager, Clinical Trial Supply and Logistics is responsible for planning and managing investigational drug, devices, and ancillary supplies for assigned clinical studies, in coordination with Clinical Operations, CMC, Regulatory, Quality, and Finance teams. The position includes the responsibility for external clinical trial medication manufacturing, packaging, labeling, inventory management, and distribution to ensure timely delivery of clinical supplies to clinical sites.

The Clinical Trial Supply and Logistics interacts with and supports the global development teams to assure the availability of clinical trial materials for planned clinical studies. This includes demand planning management, cost and resource planning, operational setup, outsourcing, surveillance, performance management, and cost control of clinical supply activities. Responsibilities also include the consolidation of demand plans and the development of supply plans to ensure a high level of security of supply, customer satisfaction, and cost control. This position will ensure full GMP compliance and documentation for clinical supply activities, along with the development of standard operating procedures and contribution to the performance and continuous improvement of global clinical trial supply processes.

This role requires good judgment, strong initiative, and the ability to effectively prioritize and manage a diversified workload, often to strict deadlines. The role also requires strong interpersonal skills, a professional approach with excellent w r i tten a nd v erbal c o m m uni c ation s ki l ls.

Responsibilities:

• Responsible for on-time distribution of clinical drug supply to the US and worldwide clinical sites.
• Responsible for coordinating shipments and working with freight forwarders in the US and worldwide
• Responsible for assuring accurate drug accountability/reconciliation for the investigational medicinal product (IMP) issued during the study to the site and at the end of the study.
• Responsible for helping with the set-up of all third-party vendor specifications (i.e. IWRS) for distribution and reconciliation of clinical trial materials.
• Support and manage the coordination of shipping studies related to clinical supplies
• Manage clinical trial supply chain operations with outside agreed/pre-selected CROs and CMOs including forecasting for all clinical trials, working closely and collaboratively with Clinical Operations, Regulatory Affairs, and other R&D functions to design appropriate planning, labeling, packaging, and distribution configurations.
• Manage supply depots in global clinical trials for inventory, distribution, expiry management, returns, and destruction
• Coordinate on-time distribution of clinical trial supply to worldwide clinical sites: ensure the scheduling and timely delivery of all necessary clinical supply materials, such as bulk drug product, label, and packaging inserts, randomization schemes, packaging and shipping configurations, labeling and distribution plans of portfolio projects.
• Participate with the team on the optimal clinical trial supply strategy in terms of packaging design, technical and timeline feasibility, efficiency, and risk management
• Participate in finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial
• Ensure that all documentation concerning CTS (Labelling, packaging, distribution, reconciliation) is available complete, and correct.
• Ensure that all supplies are controlled and distributed in accordance with GMP, GCP, and GDP regulations.
• Interact with the Clinical CRO and IVRS on supplies, replenishment, returns, and destructions.
• Review and archive any blinded documentation until the end of the clinical study.
• Monitor clinical trial supply management invoicing by CMO.
• Represent clinical trial supply chain function on internal and external cross-functional teams.
• Participate in the evaluation, identification, and selection CMOs where needed.
• Help to consolidate, maintain and track the clinical trial budget with key stakeholders for the overall external cost (e.g. labels, packaging, distribution, and comparators)
• Develop metrics to monitor and analyze clinical supply chain effectiveness
• In collaboration with QA and the Sr. Manager of Clinical Supply Chain, write and review department Standard Operating Procedures (SOPs)
  Other duties as assigned.
• Effectively manage/oversee both investigational drug and device supply chain
  
  Qualifications and Skills Required:
  
  • Proficient in Microsoft Office.
  • Professional, proactive demeanor.
  • Strong interpersonal skills.
  • Excellent written and verbal communication skills.
  • At least five year-experience in the pharmaceutical clinical trial supply chain operations, including global clinical trial drug management, such as planning, sourcing, inventory control, and logistics.
  • BSci degree preferably in pharmaceutics, or another scientific/ economic education
  • Experience managing the drug supply chain for global Phase 1 to 3 studies including knowledge of International packaging regulations, import/export licenses, CTPAT, international shipping, cold chain shipping, and drug depot utilization.
  • Experience with SAP
  • Hands-on experience in developing and managing integrated supply chain IT support systems (IWRS).
  • Advanced knowledge of labeling, packaging, inventory management, and distribution procedures (particularly IWRS systems) related to the management of clinical trial supplies.
  • Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies
  • Knowledge of business-related areas: project management, contracts, invoicing, and finance.
  • Understanding formulation/drug product process development and scale-up; packaging, technology transfer; cGMPs, ICH guidelines; as well as CMC content of regulatory submissions is also a plus.
  • Excellent planning and organization skills.
  • Demonstrates problem-solving and idea generation skills
  • Very good communication, negotiation, and interpersonal skills
  • Rigorous, reliable, rapid, and precise.
  • Willing to learn new areas of expertise as required for the position.
    Horizon Core Values & Competencies:
    
    Growth
    
    • Manages Ambiguity
    • Strategic Mindset
    • Demonstrates Self-awareness
    • Cultivates Innovation
    • Develops Talent
      
      Accountability
      
      • Drives Results
      • Ensures Accountability
      • Decision Quality
        
        Transparency
        
        • Courage
        • Collaboration
        • Instills Trust
          
          Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.
          
          Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Keywords: Horizon Therapeutics, Buffalo Grove , Manager, Clinical Trial Supply, Healthcare , Buffalo Grove, Illinois