Associate Clinical Supply Distribution Director

Summary/Job Purpose

The Associate Clinical Supply Distribution Director is responsible for implementing global logistics and distribution strategies for the clinical supply chain. Focused on delivering uninterrupted availability of supply to clinical sites and patients by setting up depot network, complying with international import and export guidance, shipment execution including shipper solutions and transit temperature monitoring device utilization and vendor oversight. Function as area Subject Matter Expert.

Essential Duties and Responsibilities

• Responsible for oversight of logistics and distribution of clinical supplies, ensuring compliance with GxP regulations.
• Comply with regulatory requirements, maintain proper documentation, including transit documents and customs clearances.
• Partner with Trade Compliance expert and support to ensure processes for proper customs valuation, VAT/tax management and reclamation, and risk management through INCO terms
• Process Owner for site-by-site shipment of drug product, importation document management, temperature excursion management, Returns/Destruction/Reconciliation
• Oversee the maintenance and compilation of distribution data to assist in budget creation and adherence
• Liaise with clinical operations and clinical supply chain project team regarding project issues and resolution
• SME partnering with vendors and internal and external industry experts to develop and maintain a database of country requirements, including import and export requirements, Health Authority lead times, transit lead times and country/region specific considerations to support effective start-up and maintenance of clinical supply chain.
• Identify opportunities to improve overall service and performance of current vendors by working within governance models and through regular communications and established KPIs.

Supervisory Responsibilities

Supervises staff

Education/Experience/Knowledge & Skills

Education/Experience:

• BS/BA degree in related discipline and a minimum of eleven years of related experience; or,
• MS/MA degree in related discipline and a minimum of nine years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• Technical experience in international pharmaceutical logistics and supply chain
• Experience in the pharmaceutical and biotech industries.

Knowledge/Skills:

• Strong knowledge and demonstrated experience in clinical supply distribution.
• Strong initiative and desire to work in a fast-paced team-oriented, and dynamic environment.
• Creativity and flexibility in problem solving; work collaboratively as part of a team
• Working knowledge of regulations relating to clinical supply distribution activities.
• Working knowledge of GMP regulations
• Excellent oral and written communication skills; along with strong demonstrated stakeholder management skills
• Demonstrated technical skills and mindset in logistic and cold chain management including process optimization and delivery of drug product
• Experience with pharmaceutical supply chain requirements and international trade compliance laws and regulations including but not limited to, imports, exports, Harmonization Tariff system (HTS), country of origin, valuations for customs declarations, dangerous goods guidelines
• Demonstrated experience in maintaining a database of import data in full compliance with reporting requirements of US Customs
• Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.