Associate Director, Clinical Supply Chain

Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: July 3, 2025

Job Description:

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. About the Opportunity :The Associate Director, Clinical Supply Chain is a strategic leader responsible for the end-to-end clinical supply strategy and operational execution for global clinical programs. This role will drive the planning, coordination, and continuous optimization of investigational product (IP) supply to ensure timely, cost-effective, and compliant support of clinical development milestones. The Associate Director will serve as the clinical supply chain expert for complex programs, provide functional leadership within the department, and influence cross-functional and external partner collaboration to enable portfolio success. Strategic Forecasting and Clinical Supply Planning Own and lead the clinical supply strategy from study concept through trial close-out for assigned global development programs Interpret clinical protocols and translate them into integrated demand forecasts, distribution models, and risk-adjusted supply plans across multiple regions - Drive scenario planning and long-range forecasting to ensure uninterrupted supply while managing risk and minimizing waste Program Leadership and Cross-Functional Collaboration: - Act as the primary clinical supply chain person for high-complexity programs, representing the team in cross-functional governances Partner with Product Supply Chain Owners, Global Study Operations, Global External Operations, Quality, Regulatory, and external vendors to align supply strategy with development, regulatory, and operational needs Influence program-level decisions to optimize development timelines, patient access, and budget adherence Vendor and Budget Oversight: Partner with sourcing and procurement, and other key departments on CMO/vendor strategy, including selection, contract negotiation, and performance management for packaging, labeling, distribution, and IRT Own clinical supply budgets for assigned programs, ensuring accurate forecasting, spend tracking, and identification of cost-saving opportunities Operational Execution and Quality Compliance: Provide strategic oversight of supply chain execution activities, including IMP packaging/labeling, depot seeding, and resupply plans Ensure compliance with global GxP, ICH, and regional regulatory requirements in clinical supply operations Drive SOP development and process improvements to enhance clinical supply performance, audit readiness, and operational scalability Leadership and Team Development: Provide guidance and mentorship to team members, supporting a culture of excellence, collaboration, and accountability May have direct people management responsibilities including coaching, performance management, and development planning Inspection Readiness and Regulatory Support: Act as subject matter expert for clinical supply chain during inspections and audits Lead the preparation of Trial Master File (TMF) content related to investigational product supply and support content for regulatory submissions Must have: Minimum Requirements: - 10 years of experience in clinical supply chain, technical operations, or clinical trial logistics within the pharmaceutical or biotech industry.- Proven track record of managing global clinical supply strategies and execution in complex and/or late-phase clinical programs.- Strong experience with vendor oversight, budgeting, and supply planning tools (e.g., IRT, SAP, forecasting platforms).- Excellent project management, interpersonal, and communication skills with ability to influence across functional levels.- In-depth knowledge of global GxP, ICH guidelines, and Health Authority requirements. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. IRT "Interactive Response Technology" RTSM "Randomization and Trial" Supply Management

Keywords: BioMarin Pharmaceutical Inc., Vacaville , Associate Director, Clinical Supply Chain, Science, Research & Development , San Rafael, California