Associate Director, Clinical Supply Chain
BioMarin Pharmaceutical Inc.About the role
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.
- Lead Clinical Supply Chain (CSC) operations for high complexity study and program, including strategy, budget and timeline development and adherence.
- Serve as the primary CSC representative for high complexity programs cross-functional governance forums.
- Drive cross functional collaboration with internal and external stakeholders to align supply strategy with development, regulatory, and operational needs.
- Influence program-level decisions to optimize timelines, patient access, and budget compliance.
- Provide guidance and mentorship to team members, sharing best practices and tools to support excellent performance
- Foster a culture of integrity, transparency, high standards and high accountability, tackling challenges with a positive attitude and proposing alternatives to support company’s objectives
- End-to-end global clinical supply operations management, including but not limited to timelines to ensure alignment overall clinical development, manufacturing, pack and label, logistics, inventory, reconciliation, and IRT, maintaining Clinical Supply Plan up to date.
- Translate clinical protocols into integrated demand forecasts and risk-adjusted supply plans across regions.
- Support long-range planning, scenario modeling, and financial forecasting to ensure uninterrupted supply and potentially identify cost efficiency.
- Provide input to Interactive Response Technology (IRT) system design, testing. Maintain system to support supply tracking and randomization.
- Partner with key stakeholders in GEO (Global External Operations) to strategize and understanding status of manufacturing operations (DS, DP and FG), storage and distribution
- Monitor and track manufacturing timelines and ensure alignment with clinical supply needs.
- Responsib
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