Remote friendly (Stevenage, England, United Kingdom)
United States
Operations
Position Summary:
You will lead the RTSM (Randomization and Trial Supply Management) function in the United States. Partner with clinical development, operations, quality, and external vendors to design and deliver patient-focused randomization and clinical supply solutions. Shape strategy, build capability, and drive consistent delivery for clinical studies.
Responsibilities:
- Lead design and delivery of RTSM strategies across Phase IβIV clinical programs and investigator-sponsored studies.
- Direct cross-functional teams and vendors to ensure on-time randomization, kit assignment, and clinical supply availability to sites and patients.
- Own risk assessments and contingency plans for trial supply and randomization activities.
- Establish and improve RTSM processes, metrics, and governance to drive quality and efficiency.
- Partner with clinical operations, biostatistics, data management, and regulatory to align RTSM with study design and compliance needs.
- Hire, coach, and develop a diverse team; foster collaboration across internal and external partners.
Basic Qualifications:
- Bachelorβs degree in life sciences, pharmacy, engineering, IT, or related field, or equivalent experience.
- 8+ years managing RTSM, IRT, or clinical supply systems in pharma/biotech.
- Experience leading cross-functional teams and managing external vendor relationships.
- Clinical trial operations experience, including randomization methods, blinding, and investigational product supply principles.
- Experience with system vendor selection, implementation, validation, and change control.
Preferred Qualifications:
- Advanced degree (or equivalent senior leadership experience).
- Experience with eClinical ecosystems and RTSM-clinical system integrations/data flows.
- Global trial support; multi-region supply and regulatory experience.
- Track record building and mentoring teams.
- Process improvement experience (metrics/dashboards).
- Knowledge of regulations and GxP expectations for clinical supply/systems.
- Strong communication with senior stakeholder presentations and escalation management.
Work Model:
Hybrid; expected to be on-site regularly.