Director, Clinical Supply Chain IRT
$203,000–$253,000 year
On-sitePrinceton, New Jersey, United States
Job Summary
Lead development and process improvement activities for Investigational Therapy Response (IRT) standards across clinical development programs. Provide expert consultancy to internal and external stakeholders on study-specific IRT solutions, process development, and program strategy. Act as the 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 modeling performance expectations. Partner with Clinical Supply Chain, Clinical Operations, Quality, IT, and external vendors to deliver fit-for-purpose IRT solutions that support efficient study start-up and reliable execution. This high-impact role operates within Summit Therapeutics' oncology clinical studies, including multiple Phase 3 trials in NSCLC and CRC, requiring strategic thinking and strong operational execution in a dynamic biotech environment.
Required Qualifications
- Bachelor's degree in life sciences, supply chain, pharmacy, or a related discipline
- 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
Desired Qualifications
- advanced degree
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