Role summary
the sr. Manager, clinical supply chain management & operational excellence leads continuous improvement efforts to streamline sops and enhance efficiency across the end-to-end clinical supply chain. This role coordinates imp planning, forecasting, labeling, packaging, distribution, inventory monitoring, and reconciliation for assigned clinical studies, and collaborates with qa, finance, tax, procurement, legal, and ra to resolve logistics issues. The position supports both clinical and commercial supply chain projects and reports to the director, supply chain management. This hybrid role requires in-person collaboration in san francisco, ca approximately 2 days per week.
Responsibilities
leads continuous improvement projects to optimize processes by analyzing kpi, and fostering cross functional collaborations for improvements
develop and manage sops, work instructions, processes, systems, and forms governing supply chain management, including international logistics, in alignment with industry standards and regulatory requirements
support projects and process improvement efforts related to supply chain management, both clinical and commercial
support budget activities, including managing proposals, contracts, po generation and invoicing approvals for clinical packaging/distribution/storage
strengthen oversight and tracking of trial master file (tmf) documents, ensuring timely, accurate, and inspection-ready documentation for all clinical supply activities
work with external courier and depot vendors to set up storage, import & export, distribution, drug return, and destruction according to the logistics sop/global standards (gdp) and related logistics procedures
facilitates and coordinates with parcel carriers, couriers, and logistics brokers regarding all aspects of service, including pre-conditioned shipping containers/materials, temperature data loggers, pick-up appointments, and expedited order and emergency delivery situations
leads and oversees the execution of temperature-controlled, on-time distribution of eidos drug supply chain, ensuring on-time delivery and manage temperature excursions as needed
coordinate with external bureaus, including customs, fda, usda, and/or other applicable country agencies, to resolve logistics issues in a timely manner
ensures the requirements and business processes associated with cross-border movements function smoothly, issues and risks are identified and managed efficiently
importer of record setup and management as applicable globally and supports import permit applications and corresponding import vat refund as needed
works with internal departments including qa, finance, tax, procurement, legal, and ra to resolve logistics issues, as required
collaborate with clinical operations and internal stakeholders to align on clinical demand requirements and ensure labeling and distribution plans remain adaptive to program timelines, study design changes, recruitment needs, geographic considerations, and manufacturing schedules. Act as cmc/supply chain sme for any potential audits
collaborate with qa counterparts to ensure inspection readiness and process control for all import/export and applicable clinical trial activities; may participate in regulatory inspections
manage and assess courier vendor’s performance and reports operational metrics (kpis) to senior management and any regulatory reporting requirements related to import and export activities
assist in the process of identifying potential supply chain vendors, reviewing proposals contributing to the selection process
qualifications
5+ years of progressive experience in supply chain within the biotech/pharmaceutical industry
a minimum of 3 years in a global forwarding/trade compliance operation role for clinical/commercial products, including import/export experience and temperature-controlled distribution protocols
bachelor’s degree in supply chain, business administration, operations management, or similar required
in-depth understanding of project management processes like lean/six sigma
understands comprehensive global pharmaceutical regulatory requirements (e.g., cgmp, gdp, 21 cfr part 11) and knowledge of relevant local pharmaceutical drug product laws and regulatory guidelines
strong ability to collaborate and build strategic relationships with internal and external stakeholders
strong understanding of import/export requirements and customs practices
able to independently resolve global import & export issues, especially in the useurope
experience in vendor oversight and managing external partnerships and relations
experience in deviation investigation and capa implementation
demonstrated ability to work in a fast-paced team environment with minimal supervision and ability to multi-task across priorities
ability to foster a culture of continuous improvement and operational excellence and act as an influential leader without positional authority
proficient in microsoft office applications, irt, and erp systems preferred
education
bachelor’s degree in supply chain, business administration, operations management, or similar required
skills
proficient in microsoft office applications, irt, and erp systems
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