Director, Clinical Supply

Key Responsibilities:

• Develop and execute clinical supply strategies aligned with development timelines and program goals.
• Execute clinical supply chain activities including labeling, packaging, distribution, inventory management, forecasting, initiation, maintenance, and expiry of clinical supplies.
• Lead commercial supply readiness activities: supply planning, inventory strategy, distribution readiness, and cross-functional coordination for product launch/commercialization.
• Manage relationships with external partners (CDMOs, CROs, logistics providers) to ensure timely, efficient, and compliant delivery.
• Lead clinical supply planning and risk mitigation to prevent disruptions.
• Liaise with stakeholders to support timely approval and execution of SOPs, batch records, lot releases, change controls, deviations, and CAPAs.
• Ensure compliance with global regulatory requirements, GMP standards, and internal quality systems.
• Collaborate with Clinical Operations, Regulatory Affairs, Quality Assurance, and CMC teams.
• Monitor inventory levels and implement proactive supply chain solutions.
• Contribute to vendor selection, contract negotiations, and budget management.
• Other responsibilities as assigned.

Education & Qualifications:

• Bachelor’s or Master’s in a scientific discipline with 12+ years of relevant experience in clinical supply chain and logistics.
• Hands-on experience managing labeling, packaging, distribution, inventory management, forecasting, and IRT initiation, maintenance, and expiry.
• Experience managing clinical supply vendors and contract manufacturers.
• Strong operational skills tracking multiple activities, deliverables, timelines, contracts, and budgets.
• In-depth knowledge of quality and regulatory aspects for multi-country clinical studies (biologics/peptides).
• Excellent problem-solving, strategic thinking, and ability to work in a fast-paced, collaborative environment.
• Strong scientific leadership, collaboration, interpersonal skills, self-awareness, and ability to manage team dynamics.