Manager, Clinical Trial Supply and Logistics
Company: Horizon Therapeutics
Location: Lake Forest
Posted on: January 17, 2020
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. Responsibilities:
- Responsible for on-time distribution of clinical drug supply to
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 investigational medicinal product
(IMP) issued during the study to the site and at the end of the
- 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
- 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
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.
- 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 of 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,
replenishments, 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 overall external cost(e.g. labels,
packaging, distribution and comparators)
- Develop metrics to monitor and analyze clinical supply chain
effectivenessIn 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 Required, Desired Education, Skills and
- 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 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
- 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 TalentAccountability
- Drives Results
- Ensures Accountability
- Decision QualityTransparency
- Instills TrustHorizon 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, Chicago , Manager, Clinical Trial Supply and Logistics, Executive , Lake Forest, Illinois
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