Director, Clinical Supply Chain IRT
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Overview
Job Description
Location: Princeton, NJ or Palo Alto, CA ONSITE
Overview of Role:
We are seeking a highly motivated, solutions-oriented Director, Clinical Supply Chain IRT to lead the development, implementation, and continuous improvement of IRT standards across clinical development programs. This is a high-impact role for a top performer who thrives in a dynamic biotech environment, can operate strategically and hands-on, and is able to translate complex clinical, operational, and supply chain requirements into clear standards, robust processes, and effective system solutions.
The Director, Clinical Supply Chain IRT will serve as the subject matter expert and process owner for IRT standards and related ways of working. The role will partner closely with Clinical Supply Chain, Clinical Operations, Quality, IT, external vendors, and study teams to deliver fit-for-purpose IRT solutions that support efficient study start-up, reliable execution, compliant change management, and scalable clinical supply operations.
Role and Responsibilities:
- Lead development and process improvement activities within and across teams, including knowledge-sharing sessions, training forums, and targeted information sessions
- Provide expert consultancy to internal and external stakeholders on study-specific IRT solutions, process development, program strategy, and practical options to meet evolving program needs
- Act as process owner for IRT processes and sub-processes, ensuring they remain clear, compliant, efficient, and scalable
- Set the standard for excellence in IRT setup, change management, and cross-functional delivery, while modelling the values, behaviors, and performance expectations required in a dynamic biotech environment
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor's degree in life sciences, supply chain, pharmacy, or a related discipline; advanced degree preferred
- Significant experience (10+ years) in Clinical Supply Chain, Clinical Operations, IRT/RTSM, or a closely related clinical development function within the pharmaceutical, biotechnology, or CRO environment
- Strong working knowledge of IRT/RTSM design, testing, UAT, change control, and study implementation processes
- Experience developing technical standards, SOPs, process documentation, risk assessments, and training materials
- Demonstrated ability to operate effectively in a fast-paced, cross-functional, and matrixed biotech environment
- Proven ability to influence stakeholders, manage competing priorities, and drive high-quality outcomes with minimal oversight
- Strategic thinker with strong operational execution capability
- Excellent written and verbal communication skills, with the ability to simplify complex information for diverse audiences
- Strong process mindset with a focus on scalability, compliance, governance, and continuous improvement
- High attention to detail and commitment to quality, inspection readiness, and documentation excellence
- Collaborative leadership style with the ability to build credibility across internal and external stakeholders
- Self-directed, adaptable, and comfortable working through ambiguity in a growing biotech environment
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