Lead design, validation, and lifecycle management of IRT systems for clinical trials. Translate protocol into IRT specifications, govern change control, manage vendor relationships, lead UAT/validation, monitor live performance, troubleshoot shipments and inventory, ensure regulatory inspection readiness, and align cross-functional teams on supply strategy and IRT operations.
Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
The Manager, Clinical Supply IRT is an experienced professional responsible for the strategy, design, configuration, validation, and lifecycle management of Interactive Response Technology (IRT) systems in support of Adverum clinical trials. This position acts as a vital link between Clinical Operations, Clinical Supply Chain, Quality Assurance (QA), Packaging/Labeling, Depots, and IRT vendors. The primary objective is to ensure accurate translation of subject randomization, site activation, inventory management, resupply logic, and shipment triggers into system design and operational execution.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverum’s Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
What You'll Do:
- · Lead IRT strategy during protocol development and study start-up.
- · Translate protocol requirements into IRT functional specifications in collaboration with functional leads.
- · Partner with Clinical Supply Chain to define inventory strategy within IRT, including buffer, overage, resupply thresholds, and expiry management.
- · Ensure packaging configuration is accurately reflected in the IRT system.
- · Own and govern all IRT enhancements and system request changes after go-live.
- · Assess the operational, site, and supply chain impact of proposed changes.
- · Act as a cross-functional impact assessor between Clinical Team, Supply Chain, QA, and IRT vendor.
- · Create and maintain a data change or systems change requests log and governance model to ensure inspection readiness.
- · Serve as the primary liaison with the IRT vendor.
- · Review and approve all necessary specifications with the internal team.
- · Lead User Acceptance Testing (UAT) and validation activities in partnership with Quality Assurance.
- · Govern change orders and mid-study updates.
- · Manage all IRT manuals with vendors and ensure effective rollout to study teams.
- · Monitor live study IRT performance.
- · Troubleshoot IRT-driven shipment and inventory issues, and collaborate with the vendor for resolution.
- · Act as the escalation point for site issues related to IRT.
- · Initiate deviations and/or CAPAs as required.
- · Prevent protocol deviations and missed dosing due to IRT misunderstandings or misalignments.
- · Align Clinical Operations, Clinical Supply Chain, Biostatistics, Data Management, and Clinical Development teams on IRT design.
- · Manage IRT training.
- · Establish an IRT governance model and best practices across trials.
- · Utilize data analytics tools to monitor supply chain performance and identify improvement areas.
- · Ensure IRT documentation supports FDA/EMA inspection readiness.
- · Maintain audit trails, validation documentation, and SOP alignment.
- · Ensure compliance with all relevant regulations and standards related to supply chain operations, including GMP and FDA requirements.
- · Identify potential risks within the supply chain and develop mitigation strategies.
- · Perform other job-related duties as assigned by management, within the reasonable scope of this position.
About You:
- · Bachelor’s degree in Life Sciences, Engineering, or a related field.
- · At least 5 years of experience in clinical trials, with a minimum of 3 years of direct IRT experience.
- · Strong understanding of clinical supply chain operations.
- · Experience with global, multi-depot studies.
- · Independent self-starter, able to lead ad-hoc teams, work without supervision, and exercise good judgment in determining objectives and approaches to assignments.
- · Systems thinking across Clinical Operations, Sites, and Supply Chain.
- · Ability to translate protocol into operational and site-friendly logic.
- · Strong vendor management and technical documentation skills.
- · Risk-based thinking for inventory and enrollment variability.
- · Expertise in managing IRT data changes and site issues without operational disruption.
Top Skills
Data Analytics Tools
Irt
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