Clinical Supply Chain Consultant

Overview

Rare disease biotechnology company in the search for an experienced Clinical Supply Chain Consultant to provide end to end oversight of clinical supply strategy and execution.

The consultant will take responsibility for the clinical supply chain across the development lifecycle, from CMC and manufacturing planning through packaging, labelling, distribution, site supply, inventory management and clinical trial closeout.

The role will work closely with Clinical Operations, CMC, Regulatory, Quality, Medical, CROs, CMOs, clinical sites and specialist vendors to ensure the right product is available at the right time, in the right condition and in compliance with applicable GMP and GCP requirements.

Key Responsibilities

Clinical Supply Strategy

• Develop and implement the end to end clinical supply strategy across Phase I to Phase III programmes
• Translate clinical development plans and protocol requirements into detailed supply forecasts and operational plans
• Determine manufacturing, packaging, labelling, storage and distribution requirements
• Develop supply models for complex and geographically dispersed rare disease studies
• Identify supply chain risks and develop appropriate mitigation and contingency strategies
• Plan for clinical demand, patient recruitment variability, expiry, shelf life and resupply requirements

CMC & Manufacturing

• Work closely with CMC, Technical Operations and Quality teams to align clinical supply requirements with the broader CMC strategy
• Support drug substance and drug product manufacturing planning
• Coordinate clinical batch requirements, manufacturing schedules and release timelines
• Provide supply chain input into formulation, packaging, stability and shelf life considerations
• Support technology transfer and manufacturing readiness where applicable
• Coordinate with CMOs/CDMOs to ensure clinical material is manufactured and released according to programme timelines
• Ensure GMP requirements are incorporated into manufacturing and supply activities

CRO & Vendor Set-Up

• Support selection, qualification and onboarding of CROs, CMOs/CDMOs, depots, couriers, packaging providers and other clinical supply vendors
• Define vendor scopes of work, responsibilities and operational requirements
• Support RFPs, vendor selection, contracting and implementation
• Establish appropriate governance structures and performance metrics
• Manage vendor performance, timelines, quality issues and escalation processes
• Ensure responsibilities are clearly defined across the sponsor, CRO and external supply chain

Packaging, Labelling & Distribution

• Oversee clinical trial packaging and labelling activities
• Coordinate country-specific labelling requirements with Regulatory and Clinical Operations
• Ensure supply is prepared in accordance with protocol, regulatory and GMP requirements
• Develop and manage global distribution strategies
• Coordinate depot and direct-to-site shipments
• Manage temperature-controlled and specialist logistics requirements where necessary
• Ensure appropriate documentation and chain of custody throughout distribution

Clinical Trial Supply Management

• Maintain oversight of clinical inventory across manufacturing sites, depots and clinical sites
• Develop forecasting and replenishment models based on enrolment and patient demand
• Monitor inventory levels, expiry and wastage
• Establish resupply triggers and contingency stock requirements
• Support management of drug accountability and reconciliation
• Work with Clinical Operations and CROs to understand recruitment and site activation forecasts
• Identify potential supply interruptions before they impact clinical trial timelines

Quality & Compliance

• Ensure clinical supply activities comply with GMP, GCP, GDP and applicable regulatory requirements
• Work closely with Quality Assurance on deviations, CAPAs, change controls and quality investigations
• Ensure appropriate documentation is maintained throughout the supply lifecycle
• Support audits and regulatory inspections relating to clinical supply activities
• Maintain appropriate oversight of temperature excursions, product complaints and supply chain incidents

Cross Functional Collaboration

The consultant will operate as a key link between:

• Clinical Development
• Clinical Operations
• CMC
• Regulatory Affairs
• Quality Assurance
• Manufacturing / Technical Operations
• Pharmacovigilance
• Finance and Procurement
• CROs and external vendors
• Clinical sites

The role will ensure that clinical supply planning remains aligned with patient recruitment, clinical timelines, CMC strategy and regulatory milestones.

Clinical Trial Closeout

• Develop and execute clinical supply closeout strategies
• Coordinate final inventory reconciliation
• Manage return, destruction or retention of clinical materials
• Support reconciliation of supplies across sites, depots and vendors
• Ensure appropriate documentation and records are maintained
• Contribute to lessons learned and supply strategy improvements for future programmes

Requirements

• Significant experience in clinical supply chain management within biotech, pharmaceutical or CRO environments
• Strong end to end understanding of clinical supply processes
• Experience supporting rare disease or complex clinical development programmes preferred
• Strong understanding of GMP, GCP and GDP requirements
• Experience working with CMOs/CDMOs, CROs, depots, logistics providers and packaging/labelling vendors
• Demonstrated experience developing clinical supply strategies across international studies
• Experience working closely with CMC and Technical Operations
• Strong understanding of clinical forecasting, demand planning, inventory management and resupply
• Experience managing external vendors and cross functional stakeholders
• Strong knowledge of clinical trial regulations and quality requirements

Preferred Experience

• Experience within a small or emerging biotech, where the individual has owned broad areas of the supply chain rather than operating within a highly siloed organisation
• Rare disease experience
• Experience with orphan drug development and small patient populations
• Experience supporting first in human and early phase clinical programmes
• Experience with temperature-controlled or specialist distribution
• Experience supporting global clinical trials
• Previous consulting or contract experience

The Opportunity

This is an opportunity for an experienced Clinical Supply Chain professional to take end to end ownership of clinical supply strategy within a rare disease biotech.

The successful consultant will have significant exposure across CMC, manufacturing, clinical operations, CRO and vendor management, quality, regulatory and global distribution, making this particularly suited to someone who enjoys operating across functions and building practical supply solutions in a lean biotech environment.