Clinical Trial Supply Manager

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Position Summary

You will provide tactical oversight of the end-to-end supply chain for assigned GSK R&D clinical studies, from protocol review through to study close-out and reconciliation. You will define detailed demand and supply plans for investigational drugs or treatments that consistently deliver on time to patients while ensuring that supply chain performance supports published study milestones. You will review and influence clinical protocols relative to investigational product supply and determine optimal, patient-focused, risk-adjusted and cost-effective supply plans. As part of the Study Team Operating model (STOM), you will act as the primary interface between supply chain and the clinical study team, ensuring accurate and timely communication across all partner organisations. This role supports Phase I-IV GSK-sponsored clinical studies, investigator-sponsored trials and compassionate use studies.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Translate clinical study protocols into operational clinical supply strategies, including demand, supply, distribution and randomisation approaches for investigational product supplies.

• Assess operational feasibility and capacity for new and changing study demands, developing scenario analyses and risk-based supply options, and escalating risks with clear recommendations.

• Act as the single point of contact between the clinical study team and clinical supply operations for study set-up, timelines, issue resolution and communication of supply status, risks and milestones.

• Create and maintain study supply plans and logistics parameters (including depot and pack site inventory policies) in relevant planning systems and follow up to ensure supply-related milestones are met.

• Manage relationships with depots, logistics partners and internal stakeholders to ensure timely, GxP-compliant delivery and continuity of clinical supplies.

• Maintain study-related documentation (SOPs, guidance, training material) and track study KPIs to identify trends and drive proactive issue resolution and continuous improvement.

Responsibilities

• Lead operational supply set-up and follow-up for one or more clinical studies, from protocol input through to study close-out and reconciliation, ensuring investigational product supply is not on the critical path.

• Serve as the primary supply chain interface with the clinical study team (Global Study Manager/Lead, Local Delivery Lead, Quality...), following STOM principles and supporting asset-level supply strategy in partnership with the Clinical Manufacturing and Supply Chain (CMSC) Workstream Lead.

• Review and challenge clinical protocols with respect to IP supply, ensuring supply feasibility, identifying constraints, and agreeing supply options and risks with study teams before study initiation.

• Develop, implement and maintain IP demand and supply plans for each assigned study, modelling demand from patient enrolment forecasts, treatment regimens, duration and protocol design, and keeping plans up to date as studies progress.

• Define and manage depot and pack site inventory policies and collaborate with worldwide depots to meet in-country requirements, including management of IP expiry, extensions, replenishment and destruction strategies.

• Ensure label content and data are defined in the appropriate systems; liaise with labelling and packaging experts on pack design and components; and ensure appropriate IRT contracts and study set-up are in place, including packing and distribution strategies and IVRS/IWRS specifications as applicable.

• Execute supply plans to deliver on published study milestones with consistent, on-time, compliant delivery to patients, while minimising waste and ensuring timely communication and escalation of supply issues.

• Lead complex problem solving across technical, quality, regulatory and operational dimensions without compromising quality, cost or delivery, maintaining appropriate documentation in accordance with GxP and the Trial Master File (TMF).

• Monitor study KPIs, identify trends and implement corrective and preventive actions, contributing to continuous improvement of supply chain processes and ways of working.

• Oversee externalised supply chain activities by creating study-specific technical agreements, providing inputs to vendor proposals and proactively identifying and resolving obstacles with external partners.

Why You?

Basic Qualification

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• University degree in life sciences, pharmacy, logistics, engineering or related field.

• Minimum 5 years' experience in clinical supply management, clinical operations or logistics for clinical trials.

• Experience with clinical trial study designs and approaches and their implications for investigational product supply chains.

• Demonstrated knowledge of investigational product supply management, inventory management and supply chain/planning principles.

• Proven ability to manage multiple and complex projects requiring strong problem-solving and innovative thinking to address global supply challenges.

• Knowledge of regulatory requirements including GMP, GCP and a solid understanding of the drug development process across phases I-IV.

• Experience with IRT/IVRS/IWRS systems, particularly for supply management and patient randomisation.

• Strong organisational and planning skills with excellent written and oral communication, and demonstrated ability to work with aggressive, changing timelines and limited information.

• Ability to lead and work effectively within cross-functional teams across functional and geographical boundaries, with operational expertise in risk management and contingency planning and strong analytical and strategic thinking.

• Fluent English (written and spoken); additional local language skills are an advantage.

Preferred Qualification

If you have the following characteristics, it would be a plus:

• APICS or CILT certification, and/or Lean Sigma training or experience.

• Project management training or experience (e.g. PMP, PRINCE2) and practical experience managing projects in a matrix or remote environment.

• Experience in warehouse outsourcing oversight, depot network management and global clinical distribution networks.

• Experience creating and maintaining study documentation (SOPs, guidance, training materials) and study KPIs to support continuous improvement of supply chain processes.

• Additional language skills (for example, French) are an asset.

Skills

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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