Clinical Trial Supply - Manager
Company: Horizon Therapeutics
Location: Mount Prospect
Posted on: June 18, 2022
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
- 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
- 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
- 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
- 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
- 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 chainQualifications 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
- BSci degree preferably in pharmaceutics, or another scientific/
- 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
- 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
- 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
Keywords: Horizon Therapeutics, Mount Prospect , Clinical Trial Supply - Manager, Executive , Mount Prospect, Illinois
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