Senior Director, Clinical Supply Chain
On-siteSan Diego, California, United States
Job Summary
Lead and develop clinical supply strategies across Phase 1–3 programs, ensuring uninterrupted IMP supply across global, multi-region trials. Manage end-to-end operations including packaging, labeling, distribution, returns, reconciliation, and destruction while overseeing external vendors, RFPs, and performance management. Provide strategic leadership for global logistics, import/export activities, and depot strategy, ensuring compliance with country-specific labeling and regulatory requirements. Partner closely with CMC, QA, and Regulatory functions to align manufacturing schedules, oversee IRT strategy, and support inspection readiness. Develop and manage clinical supply budgets, forecasts, and spend tracking while leading, mentoring, and building a scalable clinical supply team.
Required Qualifications
- Bachelor's degree in life sciences, supply chain, or related field
- 12+ years of experience in biotech/pharma supply chain
- 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
- Strong expertise in clinical supply planning, forecasting, and inventory management
- Experience managing external vendors, including CDMOs, depots, and logistics providers
- Strong working knowledge of GcP guidelines, 21 CFR and Annex 13 requirements
- 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
- United States work authorization
Desired Qualifications
- Oncology therapeutic area background strongly preferred
- Demonstrated ability to operate in a hands-on role within a small to mid-size biotech environment
- Solid understanding of GcP guidelines, 21 CFR and Annex 13 requirements
- Oncology experience strongly preferred
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