Associate Director, IRT Strategy for Clinical Trials

CSL; King of Prussia (PA); Hybrid; USD 170,000 - 210,000; Full time

Job summary

CSL Vifor is seeking an Associate Director of Clinical Trial Technology focusing on Interactive Response Technology (IRT) to drive strategy and implementation across programs. You will lead design, randomization, and product management while ensuring data integrity, regulatory alignment, and efficient vendor governance.

The role interfaces with Clinical Operations, Supply Chain, Biostatistics, and Data Management.

Qualifications

• Bachelor's degree in a scientific discipline, biological sciences, healthcare, information technology, or related field required.
• 10+ years of clinical trial technology experience within the pharmaceutical industry, CRO, and/or healthcare technology industry.
• Significant experience with Interactive Response Technology (IRT), including study design, randomization methodologies, investigational product management, and vendor oversight.
• Experience collaborating with external partners, including CROs and technology vendors.
• Demonstrated knowledge of system validation regulations and guidance for IRT and related clinical technologies.
• Proven understanding of clinical supply management principles and the role of IRT in supporting investigational product distribution, dosing, accountability, and inventory management.
• Demonstrated ability to act as an IRT subject matter expert (SME) to study teams and work closely with external partners, providing strategic and technical guidance while fostering strong collaborative relationships.
• Demonstrated ability to teach other functions the basic principles of IRT methodologies necessary to support CSL clinical trials.
• Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges.
• Project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management, and coordination skills.

Responsibilities

• Develop and implement IRT solutions that advance the clinical trial technology strategy in collaboration with Clinical Operations, Clinical Supply Chain, Biostatistics, Data Management, and other partner functions to ensure end-to-end data integrity at both the portfolio and program/study level.
• Provide strategic oversight of IRT design, randomization approaches, investigational product management, supply strategies, and system implementation to support study objectives, operational efficiency, and patient experience.
• Provide feasibility assessments and expert guidance to both insourced and outsourced program and study teams on IRT strategy, design, implementation, and oversight, including randomization methodologies, investigational product supply management, patient dosing workflows, and integration with other clinical technologies, as applicable.
• Assess and qualify external service providers and IRT solutions, sharing lessons learned and collaborating with relevant team members and external partners to drive continuous improvement, establish best practices, and ensure effective vendor oversight and governance.
• Create and maintain a communication framework for information sharing, training, and feedback with partners at the program study level, driving continuous improvement, adoption of IRT best practices, and organizational learning.
• Ensure all IRT solutions meet data quality, regulatory, and compliance requirements, including support for regulatory submissions, and align with CSL SOPs, guidelines, industry best practices, and inspection readiness expectations.
• Act as the primary point of contact, both internally and externally (e.g., vendors), for study-related IRT activities, providing strategic guidance, issue management, escalation support, and oversight throughout the study lifecyce.
• Support audits, inspections, and resolution of findings related to IRT systems and processes, ensuring appropriate documentation, traceability, and compliance with applicable regulations and CSL requirements.
• Support the development and continuous improvement of SOPs, standards, guidance documents, and governance processes related to IRT and broader clinical trial technology activities, and/or participate in cross-functional working groups focused on new processes and innovations.
• Mentor junior staff; act in an advisory capacity to Clinical Operations colleagues and cross-functional stakeholders within and across therapeutic areas on IRT strategy, best practices, and operational considerations.
• When accountable for a set of studies and/or programs, provide oversight and direction for IRT activities, ensuring appropriate delegation, vendor delivery, risk management, inter-program efficiencies, and application of lessons learned across the portfolio.

Skills

IRT strategy

IRT SME

Vendor oversight

Regulatory knowledge

Cross-functional collab

Project management

Data integrity

Clinical trial tech

Study design

Education

Bachelor's degree in a scientific discipline

Job description

CSL Vifor is seeking an Associate Director of Clinical Trial Technology focusing on Interactive Response Technology (IRT) to drive strategy and implementation across programs. You will lead design, randomization, and product management while ensuring data integrity, regulatory alignment, and efficient vendor governance.

The role interfaces with Clinical Operations, Supply Chain, Biostatistics, and Data Management.