Senior Director, Clinical Supply Chain

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Lead and develop clinical supply strategies across Phase 1–3 programs
• Ensure uninterrupted supply of IMP across global, multi-region clinical trials
• Lead the team in end-to-end clinical supply operations, including packaging, labeling, distribution, returns, reconciliation and destruction.
• Provide strategy and support in global logistics, including import/export activities and depot strategy, ensuring compliance with country-specific labeling and regulatory requirements
• Provide strategic leadership, cross-functional alignment, and operational oversight to ensure the successful execution of key activities across Clinical Operations, Quality, Regulatory, and CMC functions.

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• Contribute to and review clinical trial documentation, including clinical protocols, pharmacy manuals, batch records, drug labels, and shipping documentation. Provide oversight of IRT strategy, setup, and execution
• Partner closely with CMC to align manufacturing schedules with clinical supply needs and scale-up activitiesOversee comparator sourcing and supply strategies as needed
• Select, manage, and oversee external vendors (CDMOs, depots, packaging and logistics providers), including RFPs, SOWs, and performance management
• Partner with QA on vendor qualification, audits, compliance activities, and the development and maintenance of supply chain-related SOPs and processes.
• Ensure compliance with GcPs, and global regulatory requirements
• Support inspection readiness and regulatory submissions related to clinical supply
• Develop and manage clinical supply budgets, forecasts, and spend tracking
• Provide regular updates to leadership on supply status, risks, and planning assumptions
• Lead, mentor, and develop a small clinical supply team and build scalable processes to support company growth

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor’s degree in life sciences, supply chain, or related field
• 12+ years of experience in biotech/pharma supply chain with 4+ years of people management experience within a clinical supply chain organization.
• Strong experience supporting Phase 2 and Phase 3 clinical trials
• Proven experience supporting global clinical trials (including EU, APAC, Canada), including multi-region labeling and distribution requirements
• Biologics experience required; oncology therapeutic area background strongly preferred
• Demonstrated ability to operate in a hands-on role within a small to mid-size biotech environment
• Strong expertise in clinical supply planning, forecasting, and inventory management
• Experience managing external vendors, including CDMOs, depots, and logistics providers
• Strong working knowledge of IRT systems and clinical supply infrastructure
• Solid understanding of GcP guidelines, 21 CFR and Annex 13 requirements
• Oncology experience strongly preferred
• Experience supporting transition from early-stage to late-stage clinical development
• Experience building or scaling clinical supply chain functions in an emerging biotech environment
• Strong leadership and people management skills, with the ability to mentor and develop team members
• Excellent cross-functional communication and stakeholder management skills
• Ability to operate effectively in a fast-paced, evolving environment and navigate ambiguity
• Strong problem-solving skills with a focus on practical execution