Job Description

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us.

The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees\' personal and professional lives.

Summary

Reporting to the Director, Clinical Trial Supply, the Sr. Manager, Clinical Trial Supply and Logistics is responsible for planning, executing 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.

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 set up, outsourcing, surveillance, performance management and cost control of clinical supply activities. Responsibilities also include the consolidation of demand plans and 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 and 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 & accountable for on-time distribution of clinical drug supply to US and worldwide clinical sites.
• Responsible & accountable for coordinating shipments and working with freight forwarders in the US and worldwide
• Responsible & accountable for assuring accurate drug accountability/reconciliation for investigational medicinal product (IMP) issued during the study to the site and at the end of the study.
• Responsible for helping with 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
• Lead & 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 world-wide 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.
• Lead and influence the team on the optimal clinical trial supply strategy in terms of packaging design, technical and timeline feasibility, efficiency and risk management
• Lead and influence 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.
• Lead discussions with the Clinical CRO and IVRS on supplies, replenishments, returns and destructions.
• Review and archive any blinded documentation until the end of the clinical study.
• Manage invoicing by CMO against approved purchase orders and budgets.
• Represent clinical trial supply chain function on internal and external cross functional teams.
• Participate in the evaluation, identification and selection CMOs where needed.
• Develop, maintain and track the clinical trial budget with key stakeholders for 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 Director 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

• Manage, lead, coach direct reports as required
• Participate in the hiring process for new head count under Sr. Manager organization

Qualifications Required, Desired Education, Skills and Experience:

• At least seven 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 (Biology, Chemistry, etc.)
• 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 (IxRT).
• 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 of 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.
• Previous experience managing direct reports / Summer inters

Our Values

• Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
• Accountability: We do what\'s right for our patient communities through quality decisions and owning our successes and failures.
• Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.

These three values come to life through our five Leadership Expectations that apply to all Horizon employees

• Enterprise Mindset: Look beyond one\'s team, brand or function to see the broader company and external perspective
• Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
• Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
• Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
• Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role

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At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better.

Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Horizon Therapeutics