Director, Supply Chain and Logistics
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Company Information
Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.
Job Description
Clinical Ink is seeking a Director, Supply Chain and Logistics to to join our Logistics team based in Horsham, PA. In this role, you will lead the company’s end to end supply chain, logistics, and third party logistics (3PL) vendor operations in support of global clinical trials. This role sets the strategy and operating model for the global movement, inventory, and lifecycle management of clinical technology equipment, including electronics, medical devices, and Software as a Medical Device (SaMD) platforms, and is accountable for the performance, cost, and compliance of a leadership team of managers and coordinators, as well as for significant inventory and asset investment. The Director, Supply Chain and Logistics' responsibilities include:
Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.
Job Description
Clinical Ink is seeking a Director, Supply Chain and Logistics to to join our Logistics team based in Horsham, PA. In this role, you will lead the company’s end to end supply chain, logistics, and third party logistics (3PL) vendor operations in support of global clinical trials. This role sets the strategy and operating model for the global movement, inventory, and lifecycle management of clinical technology equipment, including electronics, medical devices, and Software as a Medical Device (SaMD) platforms, and is accountable for the performance, cost, and compliance of a leadership team of managers and coordinators, as well as for significant inventory and asset investment. The Director, Supply Chain and Logistics' responsibilities include:
- Strategy and Leadership
- Set the multi-year strategy, operating model, and roadmap for Clinical Ink’s global supply chain, logistics, and third-party logistics (3PL) vendor operations, aligned to company growth and sponsor commitments.
- Lead, develop, and hold accountable a leadership team of managers and coordinators
- Serve as a member of the Supply Chain and Support Services leadership team and partner with the Vice President to translate sponsor facing commitments into scalable, repeatable operational processes across depots, carriers, and 3PL partners worldwide.
- Global Trade and Compliance
- Own the global import and export strategy and execution for clinical trial equipment, including electronics, medical devices, and Software as a Medical Device (SaMD) platforms, ensuring compliance with customs regulations, export controls, sanctions and denied party screening, and country specific trade requirements.
- Direct product classification (Harmonized Tariff Schedule and export control classification), duty and tariff management, importer of record responsibilities, and temporary import and re-export programs; proactively manage the impact of changing tariff and trade policy on study costs and timelines.
- Ensure compliant shipment of lithium battery powered devices and other regulated goods in accordance with applicable dangerous goods regulations.
- Serve as the executive escalation point for complex customs, duties, classification, and cross border shipment issues.
- Inventory and Asset Management
- Own the inventory management system and the integrity of the clinical technology asset base, including provisioned devices, sensors and wearables, accessories, and supplies, through defined governance, cycle counting, regular reconciliation, and timely resolution of variances.
- Participate in Sales and Operations demand planning and inventory forecasting.
- Lead end to end device lifecycle logistics, including depot kitting and configuration, direct to site shipments, returns and reverse logistics, refurbishment and redeployment, and disposition at end of life.
- Vendor and Network Management
- Oversee depot network strategy and country level shipping decisions for active studies, balancing cost, regulatory requirements, and sponsor timelines.
- Establish and monitor key performance indicators for shipment lead times, on time delivery, equipment loss and damage rates, inventory accuracy, and vendor scorecards; report results to the Vice President and executive stakeholders and lead quarterly business reviews with strategic vendors.
- Maintain business continuity and risk mitigation plans for the supply chain.
- Quality, Regulatory, and Sponsor Partnership
- Partner with Regulatory, Quality, and Compliance teams to ensure logistics and vendor practices meet requirements for medical device and SaMD handling; maintain procedures, vendor qualification, audits, and corrective and preventive action (CAPA) processes in a quality managed environment.
- Direct root cause analysis and corrective action planning for logistics escalations, including late shipments, customs holds, and equipment quality issues, and drive process improvement and automation across the function.
- Represent supply chain and logistics in executive level sponsor and CRO discussions, including sponsor audits, vendor qualification, and business reviews.
- Other duties as assigned.
Qualifications
- Bachelor’s degree in supply chain management, logistics, international business, or a related field; Master's degree preferred.
- 12 or more years of progressive supply chain and logistics experience, including 7 or more years leading multi-level teams, with demonstrated experience hiring, developing, and holding leaders accountable.
- Deep expertise in international import and export operations, including customs compliance, harmonized tariff classification, export controls, sanctions screening, and trade documentation.
- Direct experience importing and exporting electronics, medical devices, or SaMD products, including familiarity with the regulatory considerations specific to those categories and with dangerous goods requirements for lithium battery powered equipment.
- Demonstrated experience implementing and governing inventory management systems at scale, including cycle counting, reconciliation, variance resolution, and sustained inventory accuracy against defined performance targets.
- Proven experience managing 3PL providers, depots, and carrier networks in a regulated environment, including contract negotiation, SLA governance, and vendor performance management.
- Experience owning a departmental budget and delivering measurable cost, service, and compliance improvements.
- Strong analytical skills, with experience building and reporting on logistics and vendor key performance indicators to senior leadership.
- Working knowledge of Salesforce, NetSuite, or comparable CRM, ERP, and inventory systems for tracking equipment requests, shipments, inventory, and vendor cases.
- Ability to manage multiple concurrent studies, vendors, and country level requirements under tight sponsor timelines.
- Executive presence and strong written and verbal communication skills, with the ability to present logistics and vendor performance data to senior leadership, sponsors, and CROs.
- Sound judgment in balancing cost, compliance, and service level considerations in logistics decision making.
- Strategic thinking with strong change management, negotiation, and cross functional influencing skills.
- Experience in clinical trials, life sciences, or clinical technology (eCOA, eConsent, eSource, decentralized trials), including provisioned device and direct to participant logistics.
- Familiarity with medical device regulatory frameworks such as the FDA Quality System Regulation, the European Union Medical Device Regulation, ISO 13485, or comparable international standards preferred.
- Professional certification such as CSCP, CLTD, CPIM, or Lean Six Sigma, or licensed customs broker credential preferred.
- Experience supporting sponsor, CRO, or regulatory audits and responding to vendor qualification questionnaires preferred.
- Experience leading a function through rapid growth, acquisition integration, or ERP and systems implementation preferred.
Additional Information
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.
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