BS/BA in a related field with 11+ years of experience, or MS/MA with 9+ years, or equivalent combination of education and experience.
Technical expertise in international pharmaceutical logistics and supply chain management.
Strong knowledge of clinical supply distribution and GMP regulations.
Excellent communication and stakeholder management skills.
Proficient in MS Office and specialized applications for logistics.
Responsibilities
Oversee logistics and distribution of clinical supplies, ensuring GxP compliance.
Maintain documentation for regulatory requirements, including customs clearances.
Collaborate with Trade Compliance experts on customs valuation and risk management.
Manage site-by-site shipment processes and temperature excursion protocols.
Compile distribution data to assist in budget creation and adherence.
Liaise with clinical operations to resolve project issues.
Develop and maintain a database of country-specific import/export requirements.
Benefits
Modern office environment that promotes collaboration and creativity.
Provision of ergonomic equipment, including dual monitors and chairs.
Supportive atmosphere encouraging idea sharing and teamwork.
Full Job Description
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.
JOB COMPLEXITY:
WORKING CONDITIONS:
Primarily working indoors in an office environment
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
About Exelixis
Exelixis is a biotechnology company that develops and commercializes innovative medicines for the treatment of cancer. The company's flagship product, CABOMETYX® (cabozantinib), is an inhibitor of multiple tyrosine kinases, including MET, AXL, and VEGFR, which are involved in the growth and spread of cancer cells. CABOMETYX is approved in the United States for the treatment of advanced renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC), and is also approved in the European Union and other countries for the treatment of advanced RCC. Exelixis is headquartered in Alameda, California, and has additional offices in South San Francisco, California, and Basel, Switzerland. Learn more at www.exelixis.com.
