Sr Supply Chain Specialist, Clinical Logistics

Role Summary

The Senior Supply Chain Specialist – Clinical Logistics owns the end-to-end movement, control, and compliance of clinical materials across a global, highly regulated supply network. This role establishes and optimizes transportation lanes; manages outsourced logistics with CMOs, 3PLs, and CTLs; and serves as the day-to-day relationship point for internal and external stakeholders. Success requires disciplined inventory control, shipment coordination, and meticulous data integrity, all while partnering with Trade Compliance, Regulatory, and Quality to uphold GxP, GDP, and SOPs within a regulated industry.

Responsibilities

• Execute end-to-end logistics for clinical cell banks, DS, and samples; establish transportation lanes and ensure alignment with CMOs and contract labs.
• Serve as the primary logistics point of contact for cross-functional teams and external partners, engaging early to build strong foundations and operating rhythms for collaboration.
• Support CMO logistics alignment, ensuring readiness, service levels, and risk mitigation plans are in place.
• Coordinate and monitor domestic and international clinical drug shipments across contract depots; ensure timely deliveries, temperature compliance, and chain-of-custody integrity.
• Proactively resolve shipping issues—including exceptions, delays, and temperature excursions—in collaboration with the Global Logistics Investigations Team.
• Partner with Trade Compliance, Regulatory, and Quality to ensure permits, documentation, and SOP requirements are met at contractor facilities (GDP/GMP, import/export and record-keeping).
• Maintain accurate clinical supply data in approved systems.
• Review inventory reports for quantity, lot status, and expiration.
• Investigate and resolve inventory discrepancies promptly; execute daily transactions including stock transfers, sales orders, work orders, adjustments, and disposals.
• Coordinate depot activities, distribution calendars, and study-startup readiness; maintain visibility to supply risks and implement mitigations.
• Identify and implement process improvements across planning, logistics, and data flows to enhance service, compliance, and cost.
• Review, author, and update departmental SOPs and work instructions, drive adherence and training.
• Address non-routine issues; facilitate meetings to communicate changes, decisions, and corrective/preventive actions.

Qualifications

• High School diploma with 9 years of relevant experience, OR associate’s degree with 7 years of relevant experience, OR Bachelor’s degree with 5 years of relevant experience, OR Master’s degree with 3 years of relevant experience
• Proven experience coordinating global shipments, temperature-controlled logistics, and working with CMOs, 3PLs, and CTLs.
• Strong knowledge of GxP/GDP principles, import/export documentation, and SOP governance; familiar with trade compliance requirements.
• Proficiency with ERP and clinical logistics systems (e.g., Oracle, CTMS, TMS, and clinical inventory tools); advanced Excel/analytics skills.
• Excellent stakeholder management, communication, and issue-resolution skills; ability to operate independently and make sound decisions in time-sensitive contexts.

Skills

• Operational Excellence: Drives OTIF service levels, data accuracy, and right-first-time execution.
• Risk Management: Anticipates supply risks; designs contingencies for cold-chain, lane capacity, and regulatory constraints.
• Collaboration: Builds trust and alignment with Clinical, Quality, Regulatory, Trade Compliance, CMOs, and logistics partners.
• Systems & Data: Ensures master data integrity; leverages analytics/dashboards for visibility and decision-making.
• Continuous Improvement: Streamlines processes via SOP updates, digital workflows, and partner SLAs.